Adverse Event Report

Report

Version of Safety Report ID2Safety Report ID10860360primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate04/02/2019reporttype1serious1seriousnessother1receivedateformat102Date Received23/02/2015receiptdateformat102Date Last Updated30/10/2018fulfillexpeditecriteria2companynumbUS-CELGENEUS-163-21880-13091984duplicate1

Report Duplicate

duplicatesourceCELGENEduplicatenumbUS-CELGENEUS-163-21880-13091984

Primary Source

reportercountryUSqualification2

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age52Unit of Onset AgeyearsWeight94.1SexMale

Contents

Reaction

1)

reactionmeddraversionpt21.1ReactionNeutropeniaOutcomeUnknown

2)

reactionmeddraversionpt21.1ReactionMuscular weaknessOutcomeUnknown

3)

reactionmeddraversionpt21.1ReactionNeuropathy peripheralOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductDEXAMETHASONE.drugstructuredosagenumb20drugstructuredosageunit003drugdosageformINJECTIONdrugadministrationroute041drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate09/07/2013

activesubstance

activesubstancenameDEXAMETHASONE

openFDA Info on Medication

Application Number NDA022315, ANDA088237, ANDA088481, NDA211379, ANDA215106, ANDA201270, ANDA088254 ... Brand Name OZURDEX, TAPERDEX 12-DAY, DEXAMETHASONE, HEMADY, DEXAMETHASONE 1.5 MG, ZCORT, TA ... Generic NameDEXAMETHASONE, DEXAMETHASONE 1.5 MGManufacturers Allergan, Inc., Xspire Pharma, Llc, Alvogen Inc., Acrotech Biopharma LLC, Fera P ... product_ndc 0023-3348, 42195-149, 42195-490, 47781-914, 47781-916, 72893-015, 48102-047, 481 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVITREAL, ORAL, INTRAOCULAR, OPHTHALMIC, INTRACANALICULARActive IngredientsDEXAMETHASONERXCUI 854177, 854181, 197580, 1943550, 1998481, 197582, 197583, 2261802, 2286261, 1975 ... spl_id 04b2b881-a84c-417c-ba09-8a76cf46faea, 450c31b5-c5c0-44bb-bde5-66748f67b156, 4ce5 ... spl_set_id 4b204f44-6e8a-4d17-803c-268f0b04679f, c3c59b82-1343-470d-bbc7-e40da3c0a28f, 9ab2 ... Package NDC 0023-3348-07, 0023-3348-08, 42195-149-12, 42195-490-12, 47781-914-01, 47781-914- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNII7S5I7G3JQL

2)

drugcharacterization2medicinalproductOMEPRAZOLE.drugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext20 MILLIGRAMdrugdosageformCAPSULESdrugadministrationroute048drugstartdateformat102drugstartdate30/01/2013

activesubstance

activesubstancenameOMEPRAZOLE

openFDA Info on Medication

Application Number NDA022032, ANDA210593, ANDA207891, ANDA075410, ANDA206877, ANDA075757, NDA209400 ... Brand Name GOOD NEIGHBOR PHARMACY OMEPRAZOLE, EQUALINE OMEPRAZOLE DELAYED RELEASE, KIRKLAND ... Generic NameOMEPRAZOLE, OMEPRAZOLE MAGNESIUMManufacturers Amerisource Bergen, Supervalu Inc, Costco Wholesale Company, INNOVUS PHARMACEUTI ... product_ndc 46122-281, 41163-614, 63981-915, 57483-740, 51660-029, 62175-114, 62175-118, 621 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE, OMEPRAZOLE MAGNESIUMRXCUI402014, 198051, 199119, 200329, 2003656spl_id f8450f59-9629-41d2-92eb-9ac30593ea31, bd28c8a0-73e5-4c81-bc0e-b2c1504a88c3, 8c9d ... spl_set_id 5ee3cb79-5c0c-456f-b5d5-d5a008bbd118, 16bf0c57-0376-48b3-90e5-502d61d1b6eb, 48a4 ... Package NDC 46122-281-04, 46122-281-74, 41163-614-01, 63981-915-55, 57483-740-01, 57483-740- ... NUIN0000175525, N0000000147, N0000182140Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNIIKG60484QX9, 426QFE7XLK

3)

drugcharacterization2medicinalproductONDANSETRON HCLdrugstructuredosagenumb8drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb8drugintervaldosagedefinition805drugdosagetext24 MILLIGRAMdrugdosageformTABLETSdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate30/05/2008

activesubstance

activesubstancenameONDANSETRON HYDROCHLORIDE

openFDA Info on Medication

4)

drugcharacterization2medicinalproductPAMIDRONATEdrugstructuredosagenumb90drugstructuredosageunit003drugdosagetext90 MILLIGRAMdrugdosageformINJECTIONdrugadministrationroute041drugstartdateformat102drugstartdate03/05/2013

activesubstance

activesubstancenamePAMIDRONATE DISODIUM

5)

drugcharacterization2medicinalproductGRANISETRONdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb12drugintervaldosagedefinition805drugdosagetext2 TABLETdrugdosageformTABLETSdrugadministrationroute048drugindicationNAUSEAdrugstartdateformat102drugstartdate13/03/2014

activesubstance

activesubstancenameGRANISETRON

openFDA Info on Medication

Application NumberNDA022198, NDA022445, ANDA078096, ANDA078090Brand NameSANCUSO, SUSTOL, GRANISETRONGeneric NameGRANISETRON, GRANISETRON HYDROCHLORIDEManufacturersKyowa Kirin, Inc., Heron Therapeutics, Fresenius Kabi USA, LLCproduct_ndc42747-726, 47426-101, 63323-318, 63323-319, 63323-317Product TypeHUMAN PRESCRIPTION DRUGRouteTRANSDERMAL, SUBCUTANEOUS, INTRAVENOUSActive IngredientsGRANISETRON, GRANISETRON HYDROCHLORIDERXCUI825003, 825005, 1810484, 1810489, 240912, 543218, 1734399spl_id 1623fcfc-ee32-4e20-9e8e-a6767a5c2e13, f8caa49c-a077-484b-80a8-fdd95a831515, 9b00 ... spl_set_id ba44e7d8-0c71-4eb9-a951-3d91038293c5, f7c7ffdd-8270-4030-bc1e-a1cb28a6de56, dddc ... Package NDC 42747-726-01, 42747-726-72, 47426-101-06, 47426-101-01, 63323-319-04, 63323-318- ... NUIN0000175817, N0000175818Mechanism of ActionSerotonin 3 Receptor Antagonists [MoA]Established Pharmacologic ClassSerotonin-3 Receptor Antagonist [EPC]UNIIWZG3J2MCOL, 318F6L70J8

6)

drugcharacterization2medicinalproductLEVOFLOXACIN.drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformUNKNOWNdrugadministrationroute048drugstartdateformat102drugstartdate29/01/2009

activesubstance

activesubstancenameLEVOFLOXACIN

openFDA Info on Medication

Application Number ANDA090268, ANDA205968, ANDA090343, ANDA206908, ANDA091375, ANDA077438, ANDA0785 ... Brand NameLEVOFLOXACINGeneric NameLEVOFLOXACIN, LEVOFLOXACIN IN 5% DEXTROSEManufacturers Akorn, Cadila Healthcare Limited, Sagent Pharmaceuticals, Gland Pharma Limited, ... product_ndc 17478-106, 70771-1079, 25021-132, 68083-414, 68083-415, 68083-416, 0143-9315, 01 ... Product TypeHUMAN PRESCRIPTION DRUGRouteOPHTHALMIC, INTRAVENOUS, ORALActive IngredientsLEVOFLOXACINRXCUI 314080, 1665517, 1665519, 1665497, 1665507, 1665515, 199884, 199885, 311296, 477 ... spl_id c95440ae-7fb1-4878-bdcd-132029d1d207, aabf0379-95a8-44bd-82e5-787a33a48433, a1a2 ... spl_set_id 6987500a-2feb-48a9-9d29-89693333a801, 74ffa693-6859-4b92-998b-775b3245d45d, 699f ... Package NDC 17478-106-10, 70771-1079-2, 70771-1079-3, 25021-132-81, 25021-132-82, 25021-132- ... NUIN0000175937, M0023650Established Pharmacologic ClassQuinolone Antimicrobial [EPC]Chemical StructureQuinolones [CS]UNII6GNT3Y5LMF

7)

drugcharacterization2medicinalproductMELPHALAN.drugdosagetextHIGH-DOSEdrugdosageformUNKNOWNdrugadministrationroute065drugstartdateformat102drugstartdate25/04/2014

activesubstance

activesubstancenameMELPHALAN

openFDA Info on Medication

Application NumberNDA207155, NDA014691, ANDA207809, ANDA203393Brand NameEVOMELA, ALKERAN, MELPHALANGeneric NameMELPHALAN, MELPHALAN USP, 2 MG, MELPHALAN HYDROCHLORIDEManufacturers Acrotech Biopharma LLC, ApoPharma USA, Inc., Alvogen Inc., Fresenius Kabi USA, L ... product_ndc68152-109, 52609-0001, 47781-200, 63323-760, 72893-001Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsMELPHALAN HYDROCHLORIDE, MELPHALANRXCUI311487, 1745090, 105562, 197919spl_id dd7dd217-449f-49aa-b839-eee22d963459, b8048e20-e808-34c5-f821-de0b006fa278, c71c ... spl_set_id c5d68b96-14bd-4605-b6d2-2bf8b0c5ca8a, ff913271-0090-4832-a0fe-5154fe8f97b9, 5bc0 ... Package NDC 68152-109-00, 52609-0001-5, 47781-200-50, 63323-760-20, 63323-761-20, 63323-732- ... UNII1VXP4V453T, Q41OR9510PNUIN0000000236, N0000175558Mechanism of ActionAlkylating Activity [MoA]Established Pharmacologic ClassAlkylating Drug [EPC]

8)

drugcharacterization2medicinalproductPOTASSIUM CITRATE.drugstructuredosagenumb10drugstructuredosageunit029drugdosagetext10 MILLIEQUIVALENTSdrugdosageformTABLETSdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenamePOTASSIUM CITRATE

openFDA Info on Medication

Application Number ANDA212799, ANDA209758, NDA019071, ANDA203546, ANDA214420, ANDA206813, ANDA21277 ... Brand NamePOTASSIUM CITRATE, UROCIT-K, POTASSIUM CITRATE EXTENDED RELEASEGeneric NamePOTASSIUM CITRATEManufacturers Bionpharma Inc., Actavis Pharma, Inc., Upsher-Smith Laboratories, LLC, Zydus Pha ... product_ndc 69452-193, 69452-194, 0591-2682, 0591-2729, 0591-2742, 0245-0070, 0245-0071, 683 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPOTASSIUM CITRATERXCUI199381, 898490, 199376, 603281, 603282, 898517spl_id b6453fd1-9688-357d-e053-2995a90a70c6, 784c8e2d-1a63-4751-ab72-38b985b1a1d4, 44a6 ... spl_set_id ca8a9a4f-3bdf-495c-8e58-714dc3f1c125, ac173781-486b-461c-97ae-8b5c69e20792, 2215 ... Package NDC 69452-193-20, 69452-193-30, 69452-194-20, 69452-194-30, 0591-2682-01, 0591-2729- ... UNIIEE90ONI6FF

9)

drugcharacterization2medicinalproductTRIMIX COMPOUNDdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

10)

drugcharacterization1medicinalproductREVLIMIDdrugbatchnumbA0201B,UNKNOWN,A0408-01,A2699Adrugauthorizationnumb021880drugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext5 MILLIGRAMdrugdosageformCAPSULESdrugadministrationroute048drugstartdateformat102drugstartdate03/09/2014drugenddateformat102drugenddate15/09/2014actiondrug1drugrecurreadministration3

activesubstance

activesubstancenameLENALIDOMIDE

openFDA Info on Medication

Application NumberNDA021880Brand NameREVLIMIDGeneric NameLENALIDOMIDEManufacturersCelgene Corporationproduct_ndc59572-402, 59572-405, 59572-410, 59572-415, 59572-420, 59572-425Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLENALIDOMIDERXCUI 602910, 602912, 616114, 616116, 643712, 643714, 643720, 643722, 1242231, 1242233 ... spl_idab1a612f-883f-4e2d-8015-2efb50b08783spl_set_id5fa97bf5-28a2-48f1-8955-f56012d296bePackage NDC 59572-402-28, 59572-402-00, 59572-405-28, 59572-405-00, 59572-410-28, 59572-410- ... NUIN0000184014Established Pharmacologic ClassThalidomide Analog [EPC]UNIIF0P408N6V4

11)

drugcharacterization2medicinalproductACYCLOVIR.drugstructuredosagenumb800drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1600 MILLIGRAMdrugdosageformTABLETSdrugadministrationroute048drugstartdateformat102drugstartdate21/04/2014

activesubstance

activesubstancenameACYCLOVIR

openFDA Info on Medication

Application Number ANDA206535, ANDA205469, ANDA203834, ANDA208702, ANDA205510, NDA018604, ANDA20245 ... Brand NameACYCLOVIR, ACYCLOVIX, SITAVIG, ZOVIRAXGeneric NameACYCLOVIR, ACYCLOVIR SODIUMManufacturers Zydus Pharmaceuticals (USA) Inc., Taro Pharmaceuticals U.S.A., Inc., Camber Phar ... product_ndc 68382-048, 68382-049, 51672-1360, 31722-777, 31722-778, 45802-044, 16714-885, 05 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, TOPICAL, ORAL, CUTANEOUS, BUCCALActive IngredientsACYCLOVIR SODIUM, ACYCLOVIRRXCUI 1734932, 1734934, 197312, 197311, 197313, 141859, 197310, 307730, 2263503, 22635 ... spl_id 515388e8-636f-42f6-a39e-bb4fc7c2e7cb, 318fdb7d-10d9-49cf-bbd1-0a7480b962d9, bf4d ... spl_set_id 69a98000-adef-4323-89a7-09e035a257d4, 962b2e1a-ba9d-4b39-b6d1-203947166482, 0910 ... Package NDC 68382-048-01, 68382-048-10, 68382-049-01, 68382-049-10, 51672-1360-1, 51672-1360 ... UNII927L42J563, X4HES1O11FNUIN0000020060, N0000180187, N0000180188, N0000175468, N0000175459Mechanism of ActionDNA Polymerase Inhibitors [MoA]Established Pharmacologic Class Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zo ...

12)

drugcharacterization2medicinalproductASPIRIN.drugstructuredosagenumb81drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext81 MILLIGRAMdrugdosageformTABLETSdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate13/08/2013

activesubstance

activesubstancenameASPIRIN

openFDA Info on Medication

Application Numberpart343, NDA203697Brand Name ASPIRIN ADULT LOW DOSE, BAYER GENUINE ASPIRIN, ZEE ASPIRIN, ENTERIC COATED ASPIR ... Generic NameASPIRIN, ASPIRIN 81 MG, ASPIRIN TABLET 325MG, ASPIRIN 325 MGManufacturers Wal-Mart Stores Inc, Unifirst First Aid Corporation, Cintas Corporation, Strateg ... product_ndc 49035-914, 47682-456, 42961-044, 49348-937, 36800-545, 0363-0587, 70000-0218, 63 ... Product TypeHUMAN OTC DRUGRouteORAL, RECTALActive IngredientsASPIRIN, CALCIUM CARBONATERXCUI 308416, 211874, 212033, 198467, 318272, 1722689, 1722695, 260847, 198471, 825180 ... spl_id 70f66f99-a450-4ab6-a3b9-c5d9207e0a79, da59962f-0c77-5c08-e053-2a95a90aaee7, 1b00 ... spl_set_id 2826d84d-b135-4e20-aeea-271e9f74f431, 356e4ff4-a7f1-4a50-9b86-2555e232b300, 4c30 ... Package NDC 49035-914-32, 47682-456-50, 47682-456-47, 42961-044-01, 42961-044-02, 42961-044- ... NUIN0000000160, N0000008836, M0001335, N0000175722, N0000175578, N0000008832Mechanism of ActionCyclooxygenase Inhibitors [MoA]Physiologic/Pharmacodynamic EffectDecreased Prostaglandin Production [PE], Decreased Platelet Aggregation [PE]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]UNIIR16CO5Y76E, H0G9379FGK

13)

drugcharacterization2medicinalproductDEXAMETHASONE.drugdosageformUNKNOWNdrugadministrationroute065drugstartdateformat102drugstartdate01/09/2016

activesubstance

activesubstancenameDEXAMETHASONE

openFDA Info on Medication

Application Number NDA022315, ANDA088237, ANDA088481, NDA211379, ANDA215106, ANDA201270, ANDA088254 ... Brand Name OZURDEX, TAPERDEX 12-DAY, DEXAMETHASONE, HEMADY, DEXAMETHASONE 1.5 MG, ZCORT, TA ... Generic NameDEXAMETHASONE, DEXAMETHASONE 1.5 MGManufacturers Allergan, Inc., Xspire Pharma, Llc, Alvogen Inc., Acrotech Biopharma LLC, Fera P ... product_ndc 0023-3348, 42195-149, 42195-490, 47781-914, 47781-916, 72893-015, 48102-047, 481 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVITREAL, ORAL, INTRAOCULAR, OPHTHALMIC, INTRACANALICULARActive IngredientsDEXAMETHASONERXCUI 854177, 854181, 197580, 1943550, 1998481, 197582, 197583, 2261802, 2286261, 1975 ... spl_id 04b2b881-a84c-417c-ba09-8a76cf46faea, 450c31b5-c5c0-44bb-bde5-66748f67b156, 4ce5 ... spl_set_id 4b204f44-6e8a-4d17-803c-268f0b04679f, c3c59b82-1343-470d-bbc7-e40da3c0a28f, 9ab2 ... Package NDC 0023-3348-07, 0023-3348-08, 42195-149-12, 42195-490-12, 47781-914-01, 47781-914- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNII7S5I7G3JQL

14)

drugcharacterization2medicinalproductGABAPENTIN.drugstructuredosagenumb300drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext900 MILLIGRAMdrugdosageformTABLETSdrugadministrationroute048drugstartdateformat102drugstartdate26/02/2013

activesubstance

activesubstancenameGABAPENTIN

openFDA Info on Medication

Application Number ANDA075360, ANDA206402, ANDA090858, NDA020882, NDA020235, NDA021129, ANDA075694, ... Brand NameGABAPENTIN, NEURONTIN, GRALISE, GABA 300-EZSGeneric NameGABAPENTINManufacturers Granules India Limited, Ascend Laboratories, LLC, Parke-Davis Div of Pfizer Inc, ... product_ndc 62207-922, 62207-923, 62207-924, 67877-428, 67877-429, 67877-222, 67877-223, 678 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGABAPENTINRXCUI 310430, 310431, 310432, 310433, 310434, 105028, 105029, 105030, 261280, 261281, ... spl_id b820e737-da30-5009-e053-2a95a90aab2d, 59afc809-201f-4cf8-95f6-67ae52c0a327, 4553 ... spl_set_id 2caac299-574d-4921-a5b8-dc9287426f11, 4d445d1d-02d1-4a59-b3b2-9ba5cd924c9a, 722d ... Package NDC 62207-922-43, 62207-922-47, 62207-922-49, 62207-923-43, 62207-923-47, 62207-923- ... NUIN0000175753, N0000008486Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII6CW7F3G59X

15)

drugcharacterization2medicinalproductTRAZODONEdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext150 MILLIGRAMdrugdosageformUNKNOWNdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate26/07/2013

activesubstance

activesubstancenameTRAZODONE HYDROCHLORIDE

openFDA Info on Medication

16)

drugcharacterization2medicinalproductBACITRACIN.drugdosageformOINTMENTdrugadministrationroute061drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameBACITRACIN

openFDA Info on Medication

Application NumberANDA203177, part333B, ANDA061212Brand Name BACITRACIN, UP AND UP FIRST AID ANTIBIOTIC, ANTIBIOTIC, SIGNATURE CARE FIRST AID ... Generic NameBACITRACIN, BACITRACIN ZINCManufacturers Civica, Inc., HART Health, Kroger Company, Xellia Pharmaceuticals ApS, Cosette P ... product_ndc 72572-025, 50332-0030, 30142-536, 45932-0026, 0713-0280, 11673-073, 36800-536, 2 ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteINTRAMUSCULAR, TOPICAL, OPHTHALMICActive IngredientsBACITRACIN, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATERXCUI562411, 1648110, 1366116, 204602, 308508, 1098408spl_id 934bb51d-4542-42ef-97e2-b4946d696a27, 3dc4d600-16df-4d0d-9924-a49256d43634, 743c ... spl_set_id 1054045a-0cda-4684-9675-312415316e83, 3d8918c6-f675-498a-8c97-e6b747f66e2d, 4490 ... Package NDC 72572-025-01, 72572-025-10, 50332-0030-4, 30142-536-64, 45932-0026-1, 45932-0026 ... NUIN0000008479Physiologic/Pharmacodynamic EffectDecreased Cell Wall Synthesis & Repair [PE]UNII58H6RWO52I, 89Y4M234ES, 057Y626693, 19371312D4

17)

drugcharacterization2medicinalproductFOLIC ACID.drugstructuredosagenumb800drugstructuredosageunit004drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext800 MICROGRAMdrugdosageformUNKNOWNdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate15/09/2014

activesubstance

activesubstancenameFOLIC ACID

openFDA Info on Medication

Brand NameVENTRIXYL, FOLIC ACID, VENEXA, VITRAMYN, MULTITAM, VITREXYL, VITREXATE, VITRANOLGeneric NameFOLIC ACIDManufacturers PureTek Corporation, Leading Pharma, LLC, Amneal Pharmaceuticals of New York LLC ... product_ndc 59088-186, 69315-127, 53746-361, 10135-182, 59088-176, 71209-007, 11534-165, 586 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSActive Ingredients .ALPHA.-TOCOPHEROL ACETATE, DL-, ASCORBIC ACID, CALCIUM CARBONATE, CHOLECALCIFER ... spl_id c705632c-cd1a-0f43-e053-2995a90aa0b3, 92322e52-3179-4738-8c8a-14fef62311d4, ca64 ... spl_set_id c29dc729-93be-2a20-e053-2a95a90a8ca3, 1ba8c407-9613-4319-ac40-0a429cb0f3f4, fd85 ... Package NDC 59088-186-54, 69315-127-01, 69315-127-10, 53746-361-01, 53746-361-10, 10135-182- ... NUIN0000193618, M0001797, M0022797, N0000175952, M0022794, N0000175951Established Pharmacologic ClassVitamin C [EPC], Vitamin D [EPC], Vitamin B12 [EPC]Chemical StructureAscorbic Acid [CS], Vitamin D [CS], Vitamin B 12 [CS]UNII WR1WPI7EW8, PQ6CK8PD0R, H0G9379FGK, 1C6V77QF41, A150AY412V, P6YC3EG204, 935E97BO ... Application Number ANDA040796, ANDA040625, ANDA204418, ANDA202437, ANDA211064, ANDA202522, ANDA0911 ... RXCUI310410, 237786

18)

drugcharacterization2medicinalproductTRIAMCINOLONE ACETONIDE.drugdosageformOINTMENTdrugadministrationroute061drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameTRIAMCINOLONE ACETONIDE

openFDA Info on Medication

Application Number NDA020468, ANDA209852, ANDA085692, ANDA212384, ANDA078104, ANDA213543, ANDA08569 ... Brand Name CHILDRENS NASACORT ALLERGY 24HR, TRIAMCINOLONE ACETONIDE, NASAL ALLERGY, BASIC C ... Generic NameTRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.05%Manufacturers Chattem, Inc., Teva Parenteral Medicines, Inc., E. Fougera & Co. a division of F ... product_ndc 41167-5900, 0703-0241, 0703-0243, 0703-0245, 0168-0002, 0168-0003, 0168-0004, 21 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRoute NASAL, INTRA-ARTICULAR, INTRAMUSCULAR, TOPICAL, INTRA-ARTERIAL, DENTAL, OPHTHALM ... Active IngredientsTRIAMCINOLONE ACETONIDERXCUI 1797913, 1797915, 1085754, 1792144, 1014314, 1085644, 1085686, 1090641, 1085633, ... spl_id 6235f3d4-7202-4591-8774-3e53dd765d4b, 3ca77574-c5e6-4c30-b8c2-3d956e34fb77, 719f ... spl_set_id 2683ce6a-c4d2-4d51-9bb6-d842581ebdd8, 1680315d-dcdc-407a-b8e8-8710587197d2, 92a1 ... Package NDC 41167-5900-2, 0703-0241-01, 0703-0243-01, 0703-0245-01, 0168-0003-15, 0168-0003- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIF446C597KA

19)

drugcharacterization2medicinalproductWARFARINdrugstructuredosagenumb12drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext12 MILLIGRAMdrugdosageformTABLETSdrugadministrationroute048drugstartdateformat102drugstartdate23/06/2014

activesubstance

activesubstancenameWARFARIN

openFDA Info on Medication

Application NumberANDA090935, ANDA202202Brand NameWARFARIN SODIUMGeneric NameWARFARINManufacturersExelan Pharmaceuticals Inc., Amneal Pharmaceuticals LLCproduct_ndc 76282-327, 76282-328, 76282-329, 76282-330, 76282-331, 76282-332, 76282-333, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsWARFARIN SODIUMRXCUI855288, 855296, 855302, 855312, 855318, 855324, 855332, 855338, 855344spl_id45e85c4e-ae91-4cf3-bd98-1d5b5aecc7c5, 02a5640e-a453-4463-976c-34d448423071spl_set_idc0cc4511-e656-4b6d-96cd-e02e76173b9d, 558b7a0d-5490-4c1b-802e-3ab3f1efe760Package NDC 76282-327-01, 76282-327-10, 76282-328-01, 76282-328-10, 76282-329-01, 76282-329- ... UNII6153CWM0CL

20)

drugcharacterization1medicinalproductREVLIMIDdrugbatchnumbA0201B,UNKNOWN,A0408-01,A2699Adrugauthorizationnumb021880drugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MILLIGRAMdrugdosageformCAPSULESdrugadministrationroute048drugstartdateformat102drugstartdate09/03/2017actiondrug1drugrecurreadministration3

activesubstance

activesubstancenameLENALIDOMIDE

openFDA Info on Medication

Application NumberNDA021880Brand NameREVLIMIDGeneric NameLENALIDOMIDEManufacturersCelgene Corporationproduct_ndc59572-402, 59572-405, 59572-410, 59572-415, 59572-420, 59572-425Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLENALIDOMIDERXCUI 602910, 602912, 616114, 616116, 643712, 643714, 643720, 643722, 1242231, 1242233 ... spl_idab1a612f-883f-4e2d-8015-2efb50b08783spl_set_id5fa97bf5-28a2-48f1-8955-f56012d296bePackage NDC 59572-402-28, 59572-402-00, 59572-405-28, 59572-405-00, 59572-410-28, 59572-410- ... NUIN0000184014Established Pharmacologic ClassThalidomide Analog [EPC]UNIIF0P408N6V4

21)

drugcharacterization2medicinalproductOMEPRAZOLE.drugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40 MILLIGRAMdrugdosageformCAPSULESdrugadministrationroute048drugstartdateformat102drugstartdate08/07/2014

activesubstance

activesubstancenameOMEPRAZOLE

openFDA Info on Medication

Application Number NDA022032, ANDA210593, ANDA207891, ANDA075410, ANDA206877, ANDA075757, NDA209400 ... Brand Name GOOD NEIGHBOR PHARMACY OMEPRAZOLE, EQUALINE OMEPRAZOLE DELAYED RELEASE, KIRKLAND ... Generic NameOMEPRAZOLE, OMEPRAZOLE MAGNESIUMManufacturers Amerisource Bergen, Supervalu Inc, Costco Wholesale Company, INNOVUS PHARMACEUTI ... product_ndc 46122-281, 41163-614, 63981-915, 57483-740, 51660-029, 62175-114, 62175-118, 621 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE, OMEPRAZOLE MAGNESIUMRXCUI402014, 198051, 199119, 200329, 2003656spl_id f8450f59-9629-41d2-92eb-9ac30593ea31, bd28c8a0-73e5-4c81-bc0e-b2c1504a88c3, 8c9d ... spl_set_id 5ee3cb79-5c0c-456f-b5d5-d5a008bbd118, 16bf0c57-0376-48b3-90e5-502d61d1b6eb, 48a4 ... Package NDC 46122-281-04, 46122-281-74, 41163-614-01, 63981-915-55, 57483-740-01, 57483-740- ... NUIN0000175525, N0000000147, N0000182140Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNIIKG60484QX9, 426QFE7XLK

22)

drugcharacterization2medicinalproductPAMIDRONATEdrugstructuredosagenumb90drugstructuredosageunit003drugdosagetext90 MILLIGRAMdrugdosageformINJECTIONdrugadministrationroute041drugstartdateformat102drugstartdate10/09/2013

activesubstance

activesubstancenamePAMIDRONATE DISODIUM

23)

drugcharacterization2medicinalproductCYCLOPHOSPHAMIDE.drugstructuredosagenumb500drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803drugdosagetext500 MILLIGRAMdrugdosageformTABLETSdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate30/01/2014

activesubstance

activesubstancenameCYCLOPHOSPHAMIDE

openFDA Info on Medication

Application Number ANDA211608, NDA212501, ANDA040745, ANDA210046, ANDA209872, ANDA204555, NDA012141 ... Brand NameCYCLOPHOSPHAMIDEGeneric NameCYCLOPHOSPHAMIDEManufacturers Cipla USA Inc., Athenex Pharmaceutical Division, LLC., Baxter Healthcare Corpora ... product_ndc 69097-516, 69097-517, 70860-218, 10019-943, 10019-944, 10019-945, 70121-1238, 70 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsCYCLOPHOSPHAMIDE ANHYDROUS, CYCLOPHOSPHAMIDERXCUI 1437968, 1437969, 2386859, 1734917, 1734919, 1734921, 197549, 197550, 2568661, 2 ... spl_id f57dbebf-f145-4e3c-bfef-b7907f6e01eb, 7eaabaf5-ac12-406b-8432-8e01db8e519d, 0eb9 ... spl_set_id 0e1cb955-99c8-4fe5-89d1-399c8e52174e, a0e99679-f939-4fb3-9d38-dfdb824f89bc, cef0 ... Package NDC 69097-516-07, 69097-517-07, 70860-218-03, 70860-218-05, 70860-218-10, 10019-943- ... NUIN0000000236, N0000175558Mechanism of ActionAlkylating Activity [MoA]Established Pharmacologic ClassAlkylating Drug [EPC]UNII6UXW23996M, 8N3DW7272P

24)

drugcharacterization2medicinalproductOSELTAMIVIR PHOSPHATE.drugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameOSELTAMIVIR PHOSPHATE

openFDA Info on Medication

Application Number ANDA209421, ANDA212784, ANDA208578, ANDA215313, ANDA209113, ANDA210186, ANDA2111 ... Brand NameOSELTAMIVIR PHOSPHATE, TAMIFLU, OSELTAMIVIR PHOSPHATE FOR ORAL SUSPENSIONGeneric NameOSELTAMIVIR PHOSPHATE, OSELTAMIVIR ACID, OSELTAMIVIRManufacturers Strides Pharma Science Limited, Ajanta Pharma USA Inc., Cadila Healthcare Limite ... product_ndc 64380-797, 64380-798, 64380-799, 27241-139, 70771-1710, 70771-1711, 70771-1712, ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOSELTAMIVIR PHOSPHATERXCUI312122, 728109, 728113, 1115698, 261315, 728111, 728115, 1115700spl_id a1279325-8446-412f-83b1-46ed6c5666c0, 3c0c1676-17c7-46dd-8068-5aae938a32b5, 2dab ... spl_set_id f26154bd-374c-44a8-983a-b2724a591653, c6f78d2d-6452-4af3-83c6-b044d1604bdc, 5811 ... Package NDC 64380-797-01, 64380-798-01, 64380-799-01, 64380-799-06, 64380-799-07, 27241-139- ... UNII4A3O49NGEZ

25)

drugcharacterization2medicinalproductPREDNISONE.drugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition803drugdosagetext5 MILLIGRAMdrugdosageformTABLETSdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenamePREDNISONE

openFDA Info on Medication

Application Number NDA202020, ANDA215246, ANDA211496, ANDA080292, ANDA088832, ANDA083677, ANDA04058 ... Brand NameRAYOS, PREDNISONEGeneric NamePREDNISONEManufacturers Horizon Therapeutics USA, Inc., Novitium Pharma LLC, GeneYork Pharmaceuticals Gr ... product_ndc 75987-020, 75987-021, 75987-022, 70954-056, 71329-106, 0378-0640, 0378-0641, 037 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREDNISONERXCUI 1303125, 1303131, 1303132, 1303134, 1303135, 1303137, 198144, 198145, 312615, 31 ... spl_id 96a17428-b512-4fd9-a64d-50160d22aaaa, 7335a293-992b-490c-ab8a-66a7ca1eea30, 4384 ... spl_set_id 281ab967-7565-4bef-9c0c-a646589c671e, 7335a293-992b-490c-ab8a-66a7ca1eea30, be50 ... Package NDC 75987-020-02, 75987-020-01, 75987-020-70, 75987-021-02, 75987-021-01, 75987-021- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIVB0R961HZT

26)

drugcharacterization2medicinalproductWARFARINdrugstructuredosagenumb1.5drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1.5 TABLETdrugdosageformTABLETSdrugadministrationroute048drugstartdateformat102drugstartdate16/05/2014

activesubstance

activesubstancenameWARFARIN

openFDA Info on Medication

Application NumberANDA090935, ANDA202202Brand NameWARFARIN SODIUMGeneric NameWARFARINManufacturersExelan Pharmaceuticals Inc., Amneal Pharmaceuticals LLCproduct_ndc 76282-327, 76282-328, 76282-329, 76282-330, 76282-331, 76282-332, 76282-333, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsWARFARIN SODIUMRXCUI855288, 855296, 855302, 855312, 855318, 855324, 855332, 855338, 855344spl_id45e85c4e-ae91-4cf3-bd98-1d5b5aecc7c5, 02a5640e-a453-4463-976c-34d448423071spl_set_idc0cc4511-e656-4b6d-96cd-e02e76173b9d, 558b7a0d-5490-4c1b-802e-3ab3f1efe760Package NDC 76282-327-01, 76282-327-10, 76282-328-01, 76282-328-10, 76282-329-01, 76282-329- ... UNII6153CWM0CL

27)

drugcharacterization2medicinalproductCARFILZOMIBdrugdosageformUNKNOWNdrugadministrationroute065drugstartdateformat102drugstartdate09/03/2017

activesubstance

activesubstancenameCARFILZOMIB

openFDA Info on Medication

Application NumberNDA202714Brand NameKYPROLISGeneric NameCARFILZOMIBManufacturersOnyx Pharmaceuticals, Inc.product_ndc76075-101, 76075-102, 76075-103Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsCARFILZOMIBRXCUI1806934, 1806937, 1806940, 1806942, 2046642, 2046644spl_id33590062-5bed-4032-9347-4f9e8b53b860spl_set_idea66eb30-e665-4693-99a1-a9d3b4bbe2d6Package NDC76075-101-01, 76075-102-01, 76075-103-01NUIN0000175604, N0000175075Established Pharmacologic ClassProteasome Inhibitor [EPC]Mechanism of ActionProteasome Inhibitors [MoA]UNII72X6E3J5AR

28)

drugcharacterization2medicinalproductALLOPURINOL.drugstructuredosagenumb300drugstructuredosageunit003drugdosagetext300 MILLIGRAMdrugdosageformTABLETSdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameALLOPURINOL

openFDA Info on Medication

Application Number NDA020298, ANDA203154, ANDA212363, ANDA071450, ANDA204467, NDA018832, NDA018877, ... Brand NameALOPRIM, ALLOPURINOL, ZYLOPRIMGeneric NameALLOPURINOLManufacturers Mylan Institutional LLC, Accord Healthcare Inc., Gland Pharma Limited, Sun Pharm ... product_ndc 67457-978, 16729-134, 16729-135, 68083-380, 53489-156, 53489-157, 23155-693, 231 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsALLOPURINOL SODIUM, ALLOPURINOLRXCUI252931, 261265, 197319, 197320, 213995, 213998spl_id 2acff21e-7d8f-4b03-b7b7-9400f54f66ac, d10d00c1-a0d9-6fd8-e053-2a95a90a588a, 6a0e ... spl_set_id 018525b1-e37d-4ff2-9dc3-36b3d90ac3e0, 682dd8b8-fc6e-47c5-95b7-82d7ad96b750, 4839 ... Package NDC 67457-978-50, 16729-134-10, 16729-134-01, 16729-134-16, 16729-134-17, 16729-135- ... UNII428673RC2Z, 63CZ7GJN5INUIN0000175698, N0000000206Established Pharmacologic ClassXanthine Oxidase Inhibitor [EPC]Mechanism of ActionXanthine Oxidase Inhibitors [MoA]

29)

drugcharacterization2medicinalproductACYCLOVIR.drugstructuredosagenumb800drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1600 MILLIGRAMdrugdosageformTABLETSdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate06/08/2013

activesubstance

activesubstancenameACYCLOVIR

openFDA Info on Medication

Application Number ANDA206535, ANDA205469, ANDA203834, ANDA208702, ANDA205510, NDA018604, ANDA20245 ... Brand NameACYCLOVIR, ACYCLOVIX, SITAVIG, ZOVIRAXGeneric NameACYCLOVIR, ACYCLOVIR SODIUMManufacturers Zydus Pharmaceuticals (USA) Inc., Taro Pharmaceuticals U.S.A., Inc., Camber Phar ... product_ndc 68382-048, 68382-049, 51672-1360, 31722-777, 31722-778, 45802-044, 16714-885, 05 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, TOPICAL, ORAL, CUTANEOUS, BUCCALActive IngredientsACYCLOVIR SODIUM, ACYCLOVIRRXCUI 1734932, 1734934, 197312, 197311, 197313, 141859, 197310, 307730, 2263503, 22635 ... spl_id 515388e8-636f-42f6-a39e-bb4fc7c2e7cb, 318fdb7d-10d9-49cf-bbd1-0a7480b962d9, bf4d ... spl_set_id 69a98000-adef-4323-89a7-09e035a257d4, 962b2e1a-ba9d-4b39-b6d1-203947166482, 0910 ... Package NDC 68382-048-01, 68382-048-10, 68382-049-01, 68382-049-10, 51672-1360-1, 51672-1360 ... UNII927L42J563, X4HES1O11FNUIN0000020060, N0000180187, N0000180188, N0000175468, N0000175459Mechanism of ActionDNA Polymerase Inhibitors [MoA]Established Pharmacologic Class Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zo ...

30)

drugcharacterization2medicinalproductPAMIDRONATEdrugstructuredosagenumb90drugstructuredosageunit003drugdosagetext90 MILLIGRAMdrugdosageformINJECTIONdrugadministrationroute041drugstartdateformat102drugstartdate03/09/2013

activesubstance

activesubstancenamePAMIDRONATE DISODIUM

31)

drugcharacterization2medicinalproductCYCLOPHOSPHAMIDE.drugdosageformUNKNOWNdrugadministrationroute048drugstartdateformat102drugstartdate02/01/2014

activesubstance

activesubstancenameCYCLOPHOSPHAMIDE

openFDA Info on Medication

Application Number ANDA211608, NDA212501, ANDA040745, ANDA210046, ANDA209872, ANDA204555, NDA012141 ... Brand NameCYCLOPHOSPHAMIDEGeneric NameCYCLOPHOSPHAMIDEManufacturers Cipla USA Inc., Athenex Pharmaceutical Division, LLC., Baxter Healthcare Corpora ... product_ndc 69097-516, 69097-517, 70860-218, 10019-943, 10019-944, 10019-945, 70121-1238, 70 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsCYCLOPHOSPHAMIDE ANHYDROUS, CYCLOPHOSPHAMIDERXCUI 1437968, 1437969, 2386859, 1734917, 1734919, 1734921, 197549, 197550, 2568661, 2 ... spl_id f57dbebf-f145-4e3c-bfef-b7907f6e01eb, 7eaabaf5-ac12-406b-8432-8e01db8e519d, 0eb9 ... spl_set_id 0e1cb955-99c8-4fe5-89d1-399c8e52174e, a0e99679-f939-4fb3-9d38-dfdb824f89bc, cef0 ... Package NDC 69097-516-07, 69097-517-07, 70860-218-03, 70860-218-05, 70860-218-10, 10019-943- ... NUIN0000000236, N0000175558Mechanism of ActionAlkylating Activity [MoA]Established Pharmacologic ClassAlkylating Drug [EPC]UNII6UXW23996M, 8N3DW7272P

32)

drugcharacterization2medicinalproductGRANISETRONdrugindicationVOMITING

activesubstance

activesubstancenameGRANISETRON

openFDA Info on Medication

Application NumberNDA022198, NDA022445, ANDA078096, ANDA078090Brand NameSANCUSO, SUSTOL, GRANISETRONGeneric NameGRANISETRON, GRANISETRON HYDROCHLORIDEManufacturersKyowa Kirin, Inc., Heron Therapeutics, Fresenius Kabi USA, LLCproduct_ndc42747-726, 47426-101, 63323-318, 63323-319, 63323-317Product TypeHUMAN PRESCRIPTION DRUGRouteTRANSDERMAL, SUBCUTANEOUS, INTRAVENOUSActive IngredientsGRANISETRON, GRANISETRON HYDROCHLORIDERXCUI825003, 825005, 1810484, 1810489, 240912, 543218, 1734399spl_id 1623fcfc-ee32-4e20-9e8e-a6767a5c2e13, f8caa49c-a077-484b-80a8-fdd95a831515, 9b00 ... spl_set_id ba44e7d8-0c71-4eb9-a951-3d91038293c5, f7c7ffdd-8270-4030-bc1e-a1cb28a6de56, dddc ... Package NDC 42747-726-01, 42747-726-72, 47426-101-06, 47426-101-01, 63323-319-04, 63323-318- ... NUIN0000175817, N0000175818Mechanism of ActionSerotonin 3 Receptor Antagonists [MoA]Established Pharmacologic ClassSerotonin-3 Receptor Antagonist [EPC]UNIIWZG3J2MCOL, 318F6L70J8

33)

drugcharacterization2medicinalproductLISINOPRIL.drugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext5 MILLIGRAMdrugdosageformTABLETSdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate17/10/2013

activesubstance

activesubstancenameLISINOPRIL

openFDA Info on Medication

Application Number ANDA076063, ANDA077321, ANDA077622, NDA208401, ANDA078402, ANDA208920, ANDA21204 ... Brand NameLISINOPRIL, QBRELIS, ZESTRILGeneric NameLISINOPRILManufacturers Hikma Pharmaceuticals USA Inc., International Laboratories, LLC, Rising Pharma H ... product_ndc 0143-9713, 0143-9715, 0143-9714, 54458-872, 54458-877, 54458-874, 54458-873, 165 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLISINOPRILRXCUI 311354, 314076, 314077, 197884, 205326, 311353, 1806884, 1806890, 104375, 104376 ... spl_id 533f6e0f-04a0-4ef7-81b8-0a7be07ddd1a, b685bb45-44a6-4afc-bb3e-940bce536bda, c031 ... spl_set_id b70933da-55b2-4025-a00e-63ce3e6b7fdf, 6eef83b4-ce4c-462b-bcfa-eefa525e682d, c031 ... Package NDC 0143-9715-01, 0143-9715-10, 0143-9715-99, 0143-9714-01, 0143-9714-10, 0143-9714- ... UNIIE7199S1YWR

34)

drugcharacterization2medicinalproductLORAZEPAM.drugseparatedosagenumb1drugintervaldosageunitnumb4drugintervaldosagedefinition805drugdosagetext1-2 TABLETdrugdosageformTABLETSdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate07/05/2014

activesubstance

activesubstancenameLORAZEPAM

openFDA Info on Medication

Application Number ANDA076150, NDA018140, ANDA203572, ANDA074282, ANDA072755, ANDA090260, ANDA07502 ... Brand NameLORAZEPAM, LOREEV XR, ATIVANGeneric NameLORAZEPAMManufacturers International Medication Systems, Limited, Hikma Pharmaceuticals USA Inc., Aurol ... product_ndc 76329-8261, 0641-6207, 13107-083, 13107-084, 13107-085, 0409-6778, 0054-3532, 01 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsLORAZEPAMRXCUI 238100, 197900, 197901, 197902, 1665188, 311376, 238101, 1665326, 2569564, 25695 ... spl_id 8b30da4f-e5a1-4e8a-9971-b5c687508d81, 4f2988b1-2854-4051-962f-07cc925608ab, 66ed ... spl_set_id 7dda070d-7809-46c4-8592-eb4e4c509707, b79b38ee-c29d-4099-964f-000031f47f5a, 5b85 ... Package NDC 76329-8261-1, 0641-6207-01, 0641-6207-25, 13107-083-11, 13107-083-01, 13107-083- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIO26FZP769L

35)

drugcharacterization2medicinalproductSULFAMETHOXAZOLE TRIMETHOPRIMdrugdosageformUNKNOWNdrugadministrationroute065drugstartdateformat102drugstartdate09/06/2014drugenddateformat602drugenddate//2014

activesubstance

activesubstancenameSULFAMETHOXAZOLE\TRIMETHOPRIM

openFDA Info on Medication

36)

drugcharacterization1medicinalproductREVLIMIDdrugbatchnumbA0201B,UNKNOWN,A0408-01,A2699Adrugauthorizationnumb021880drugstructuredosagenumb25drugstructuredosageunit003drugdosagetext25 MILLIGRAMdrugdosageformCAPSULESdrugadministrationroute048drugstartdateformat102drugstartdate03/09/2013drugenddateformat102drugenddate10/09/2013actiondrug1drugrecurreadministration3

activesubstance

activesubstancenameLENALIDOMIDE

openFDA Info on Medication

Application NumberNDA021880Brand NameREVLIMIDGeneric NameLENALIDOMIDEManufacturersCelgene Corporationproduct_ndc59572-402, 59572-405, 59572-410, 59572-415, 59572-420, 59572-425Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLENALIDOMIDERXCUI 602910, 602912, 616114, 616116, 643712, 643714, 643720, 643722, 1242231, 1242233 ... spl_idab1a612f-883f-4e2d-8015-2efb50b08783spl_set_id5fa97bf5-28a2-48f1-8955-f56012d296bePackage NDC 59572-402-28, 59572-402-00, 59572-405-28, 59572-405-00, 59572-410-28, 59572-410- ... NUIN0000184014Established Pharmacologic ClassThalidomide Analog [EPC]UNIIF0P408N6V4

37)

drugcharacterization2medicinalproductPAMIDRONATEdrugstructuredosagenumb90drugstructuredosageunit003drugdosagetext90 MILLIGRAMdrugdosageformINJECTIONdrugadministrationroute041drugstartdateformat102drugstartdate02/08/2013

activesubstance

activesubstancenamePAMIDRONATE DISODIUM

38)

drugcharacterization2medicinalproductTOPIRAMATE.drugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext100 MILLIGRAMdrugdosageformUNKNOWNdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameTOPIRAMATE

openFDA Info on Medication

Application Number ANDA215414, ANDA078462, ANDA078235, ANDA079162, NDA020505, NDA020844, NDA205122, ... Brand NameTOPIRAMATE, TOPAMAX, EPRONTIA, QUDEXY XR, TROKENDI XRGeneric NameTOPIRAMATEManufacturers Camber Pharmaceuticals, Inc., Rising Pharma Holdings, Inc., Cadila Healthcare Li ... product_ndc 31722-181, 31722-182, 31722-183, 31722-184, 16571-705, 16571-706, 16571-707, 165 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTOPIRAMATERXCUI 151226, 199888, 199889, 199890, 151227, 151228, 151229, 152855, 205315, 205316, ... spl_id 18aa4aae-c619-4a0e-a69e-b8c5bd7466bc, 9bb758cd-a042-4d34-ae5a-42769a8e4a36, ecd7 ... spl_set_id cefbc5f4-ef5f-4732-ab96-a69a183f0b6b, 296c5387-1bf4-4137-87f2-2ebab4933e2c, 5701 ... Package NDC 31722-181-60, 31722-181-05, 31722-182-60, 31722-182-05, 31722-183-60, 31722-183- ... NUIN0000008486, N0000185506, N0000182140Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]Mechanism of ActionCytochrome P450 3A4 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNII0H73WJJ391

39)

drugcharacterization2medicinalproductTRAZODONEdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext50 MILLIGRAMdrugdosageformTABLETSdrugadministrationroute048drugstartdateformat102drugstartdate12/08/2014

activesubstance

activesubstancenameTRAZODONE HYDROCHLORIDE

openFDA Info on Medication

40)

drugcharacterization2medicinalproductVITAMIN B12drugstructuredosagenumb1000drugstructuredosageunit004drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1000 MICROGRAMdrugdosageformUNKNOWNdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate15/09/2014

activesubstance

activesubstancenameCYANOCOBALAMIN

41)

drugcharacterization2medicinalproductLEVOFLOXACIN.drugstructuredosagenumb500drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext500 MILLIGRAMdrugdosageformUNKNOWNdrugadministrationroute048drugstartdateformat102drugstartdate13/04/2010

activesubstance

activesubstancenameLEVOFLOXACIN

openFDA Info on Medication

Application Number ANDA090268, ANDA205968, ANDA090343, ANDA206908, ANDA091375, ANDA077438, ANDA0785 ... Brand NameLEVOFLOXACINGeneric NameLEVOFLOXACIN, LEVOFLOXACIN IN 5% DEXTROSEManufacturers Akorn, Cadila Healthcare Limited, Sagent Pharmaceuticals, Gland Pharma Limited, ... product_ndc 17478-106, 70771-1079, 25021-132, 68083-414, 68083-415, 68083-416, 0143-9315, 01 ... Product TypeHUMAN PRESCRIPTION DRUGRouteOPHTHALMIC, INTRAVENOUS, ORALActive IngredientsLEVOFLOXACINRXCUI 314080, 1665517, 1665519, 1665497, 1665507, 1665515, 199884, 199885, 311296, 477 ... spl_id c95440ae-7fb1-4878-bdcd-132029d1d207, aabf0379-95a8-44bd-82e5-787a33a48433, a1a2 ... spl_set_id 6987500a-2feb-48a9-9d29-89693333a801, 74ffa693-6859-4b92-998b-775b3245d45d, 699f ... Package NDC 17478-106-10, 70771-1079-2, 70771-1079-3, 25021-132-81, 25021-132-82, 25021-132- ... NUIN0000175937, M0023650Established Pharmacologic ClassQuinolone Antimicrobial [EPC]Chemical StructureQuinolones [CS]UNII6GNT3Y5LMF

42)

drugcharacterization2medicinalproductPROMETHAZINEdrugseparatedosagenumb1drugintervaldosageunitnumb6drugintervaldosagedefinition805drugdosageformTABLETSdrugadministrationroute048drugindicationNAUSEAdrugstartdateformat102drugstartdate16/01/2014

activesubstance

activesubstancenamePROMETHAZINE\PROMETHAZINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA040882Brand NamePROMETHAZINE HYDROCHLORIDEGeneric NamePROMETHAZINEManufacturersAmneal Pharmaceuticals LLCproduct_ndc65162-678Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPROMETHAZINE HYDROCHLORIDERXCUI992432spl_id43553934-cb17-455f-bb9a-3f44b9da0cbbspl_set_idafb16e94-03bf-4ea2-b2fe-e65f274e55a9Package NDC65162-678-86, 65162-678-90UNIIR61ZEH7I1I

43)

drugcharacterization2medicinalproductSULFAMETHOXAZOLE TRIMETHOPRIMdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext400-80MGdrugdosageformTABLETSdrugadministrationroute048drugstartdateformat102drugstartdate21/07/2014

activesubstance

activesubstancenameSULFAMETHOXAZOLE\TRIMETHOPRIM

openFDA Info on Medication

44)

drugcharacterization2medicinalproductWARFARINdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate07/05/2014

activesubstance

activesubstancenameWARFARIN

openFDA Info on Medication

Application NumberANDA090935, ANDA202202Brand NameWARFARIN SODIUMGeneric NameWARFARINManufacturersExelan Pharmaceuticals Inc., Amneal Pharmaceuticals LLCproduct_ndc 76282-327, 76282-328, 76282-329, 76282-330, 76282-331, 76282-332, 76282-333, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsWARFARIN SODIUMRXCUI855288, 855296, 855302, 855312, 855318, 855324, 855332, 855338, 855344spl_id45e85c4e-ae91-4cf3-bd98-1d5b5aecc7c5, 02a5640e-a453-4463-976c-34d448423071spl_set_idc0cc4511-e656-4b6d-96cd-e02e76173b9d, 558b7a0d-5490-4c1b-802e-3ab3f1efe760Package NDC 76282-327-01, 76282-327-10, 76282-328-01, 76282-328-10, 76282-329-01, 76282-329- ... UNII6153CWM0CL

45)

drugcharacterization2medicinalproductCARFILZOMIBdrugdosageformUNKNOWNdrugadministrationroute065drugindicationROUTINE HEALTH MAINTENANCEdrugstartdateformat102drugstartdate01/09/2016

activesubstance

activesubstancenameCARFILZOMIB

openFDA Info on Medication

Application NumberNDA202714Brand NameKYPROLISGeneric NameCARFILZOMIBManufacturersOnyx Pharmaceuticals, Inc.product_ndc76075-101, 76075-102, 76075-103Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsCARFILZOMIBRXCUI1806934, 1806937, 1806940, 1806942, 2046642, 2046644spl_id33590062-5bed-4032-9347-4f9e8b53b860spl_set_idea66eb30-e665-4693-99a1-a9d3b4bbe2d6Package NDC76075-101-01, 76075-102-01, 76075-103-01NUIN0000175604, N0000175075Established Pharmacologic ClassProteasome Inhibitor [EPC]Mechanism of ActionProteasome Inhibitors [MoA]UNII72X6E3J5AR

46)

drugcharacterization1medicinalproductREVLIMIDdrugbatchnumbA0201B,UNKNOWN,A0408-01,A2699Adrugauthorizationnumb021880drugstructuredosagenumb15drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext15 MILLIGRAMdrugdosageformCAPSULESdrugadministrationroute048drugstartdateformat610drugstartdate/09/2016actiondrug1drugrecurreadministration3

activesubstance

activesubstancenameLENALIDOMIDE

openFDA Info on Medication

Application NumberNDA021880Brand NameREVLIMIDGeneric NameLENALIDOMIDEManufacturersCelgene Corporationproduct_ndc59572-402, 59572-405, 59572-410, 59572-415, 59572-420, 59572-425Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLENALIDOMIDERXCUI 602910, 602912, 616114, 616116, 643712, 643714, 643720, 643722, 1242231, 1242233 ... spl_idab1a612f-883f-4e2d-8015-2efb50b08783spl_set_id5fa97bf5-28a2-48f1-8955-f56012d296bePackage NDC 59572-402-28, 59572-402-00, 59572-405-28, 59572-405-00, 59572-410-28, 59572-410- ... NUIN0000184014Established Pharmacologic ClassThalidomide Analog [EPC]UNIIF0P408N6V4

47)

drugcharacterization2medicinalproductGABAPENTIN.drugstructuredosagenumb300drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext600 MILLIGRAMdrugdosageformTABLETSdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate09/12/2011

activesubstance

activesubstancenameGABAPENTIN

openFDA Info on Medication

Application Number ANDA075360, ANDA206402, ANDA090858, NDA020882, NDA020235, NDA021129, ANDA075694, ... Brand NameGABAPENTIN, NEURONTIN, GRALISE, GABA 300-EZSGeneric NameGABAPENTINManufacturers Granules India Limited, Ascend Laboratories, LLC, Parke-Davis Div of Pfizer Inc, ... product_ndc 62207-922, 62207-923, 62207-924, 67877-428, 67877-429, 67877-222, 67877-223, 678 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGABAPENTINRXCUI 310430, 310431, 310432, 310433, 310434, 105028, 105029, 105030, 261280, 261281, ... spl_id b820e737-da30-5009-e053-2a95a90aab2d, 59afc809-201f-4cf8-95f6-67ae52c0a327, 4553 ... spl_set_id 2caac299-574d-4921-a5b8-dc9287426f11, 4d445d1d-02d1-4a59-b3b2-9ba5cd924c9a, 722d ... Package NDC 62207-922-43, 62207-922-47, 62207-922-49, 62207-923-43, 62207-923-47, 62207-923- ... NUIN0000175753, N0000008486Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII6CW7F3G59X

48)

drugcharacterization2medicinalproductMORPHINE SULFATE.drugstructuredosagenumb4drugstructuredosageunit003drugdosageformINJECTIONdrugadministrationroute041drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate18/01/2013

activesubstance

activesubstancenameMORPHINE SULFATE

openFDA Info on Medication

Application Number ANDA202861, NDA018565, ANDA205509, NDA202515, ANDA203602, ANDA205386, ANDA074862 ... Brand Name MORPHINE SULFATE, INFUMORPH 200, INFUMORPH 500, MORPHINE SULFATE EXTENDED RELEAS ... Generic NameMORPHINE SULFATEManufacturers International Medication Systems, Limited, Hikma Pharmaceuticals USA Inc., ANI P ... product_ndc 76329-1912, 0641-6039, 0641-6040, 62559-170, 62559-171, 0409-1890, 0409-1891, 04 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, EPIDURAL, INTRATHECAL, ORAL, INTRAMUSCULAR, RECTALActive IngredientsMORPHINE SULFATEspl_id 15b3760b-a073-4480-a7f5-01ed5524db31, b0d9ea27-fef2-4eb7-a800-98eaacd6c2a5, 16a2 ... spl_set_id 1034467f-d436-4b87-a902-c7e8885daa8a, db9ac9e3-d761-4a99-9f34-4946ebe8f255, 6cef ... Package NDC 76329-1912-1, 0641-6039-01, 0641-6040-01, 62559-170-01, 62559-170-05, 62559-171- ... UNIIX3P646A2J0RXCUI 892652, 1731522, 1731998, 1731999, 892589, 894780, 894912, 998212, 998213, 17291 ...

49)

drugcharacterization2medicinalproductOMEPRAZOLE.drugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext20 MILLIGRAMdrugdosageformCAPSULESdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate17/04/2009

activesubstance

activesubstancenameOMEPRAZOLE

openFDA Info on Medication

Application Number NDA022032, ANDA210593, ANDA207891, ANDA075410, ANDA206877, ANDA075757, NDA209400 ... Brand Name GOOD NEIGHBOR PHARMACY OMEPRAZOLE, EQUALINE OMEPRAZOLE DELAYED RELEASE, KIRKLAND ... Generic NameOMEPRAZOLE, OMEPRAZOLE MAGNESIUMManufacturers Amerisource Bergen, Supervalu Inc, Costco Wholesale Company, INNOVUS PHARMACEUTI ... product_ndc 46122-281, 41163-614, 63981-915, 57483-740, 51660-029, 62175-114, 62175-118, 621 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE, OMEPRAZOLE MAGNESIUMRXCUI402014, 198051, 199119, 200329, 2003656spl_id f8450f59-9629-41d2-92eb-9ac30593ea31, bd28c8a0-73e5-4c81-bc0e-b2c1504a88c3, 8c9d ... spl_set_id 5ee3cb79-5c0c-456f-b5d5-d5a008bbd118, 16bf0c57-0376-48b3-90e5-502d61d1b6eb, 48a4 ... Package NDC 46122-281-04, 46122-281-74, 41163-614-01, 63981-915-55, 57483-740-01, 57483-740- ... NUIN0000175525, N0000000147, N0000182140Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNIIKG60484QX9, 426QFE7XLK

50)

drugcharacterization2medicinalproductCYCLOPHOSPHAMIDE.drugdosageformUNKNOWNdrugadministrationroute048drugstartdateformat102drugstartdate27/02/2014

activesubstance

activesubstancenameCYCLOPHOSPHAMIDE

openFDA Info on Medication

Application Number ANDA211608, NDA212501, ANDA040745, ANDA210046, ANDA209872, ANDA204555, NDA012141 ... Brand NameCYCLOPHOSPHAMIDEGeneric NameCYCLOPHOSPHAMIDEManufacturers Cipla USA Inc., Athenex Pharmaceutical Division, LLC., Baxter Healthcare Corpora ... product_ndc 69097-516, 69097-517, 70860-218, 10019-943, 10019-944, 10019-945, 70121-1238, 70 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsCYCLOPHOSPHAMIDE ANHYDROUS, CYCLOPHOSPHAMIDERXCUI 1437968, 1437969, 2386859, 1734917, 1734919, 1734921, 197549, 197550, 2568661, 2 ... spl_id f57dbebf-f145-4e3c-bfef-b7907f6e01eb, 7eaabaf5-ac12-406b-8432-8e01db8e519d, 0eb9 ... spl_set_id 0e1cb955-99c8-4fe5-89d1-399c8e52174e, a0e99679-f939-4fb3-9d38-dfdb824f89bc, cef0 ... Package NDC 69097-516-07, 69097-517-07, 70860-218-03, 70860-218-05, 70860-218-10, 10019-943- ... NUIN0000000236, N0000175558Mechanism of ActionAlkylating Activity [MoA]Established Pharmacologic ClassAlkylating Drug [EPC]UNII6UXW23996M, 8N3DW7272P

51)

drugcharacterization2medicinalproductENOXAPARINdrugdosageformUNKNOWNdrugadministrationroute058drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate07/05/2014

activesubstance

activesubstancenameENOXAPARIN

52)

drugcharacterization2medicinalproductHYDROCODONE BITARTRATE AND ACETAMINOPHENdrugseparatedosagenumb1drugintervaldosageunitnumb4drugintervaldosagedefinition805drugdosagetext5/325drugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate27/10/2008

activesubstance

activesubstancenameACETAMINOPHEN\HYDROCODONE BITARTRATE

openFDA Info on Medication

Application Number ANDA211023, ANDA202214, ANDA206245, ANDA203863, ANDA206869, ANDA202991, ANDA2077 ... Brand NameHYDROCODONE BITARTRATE AND ACETAMINOPHEN, LORTABGeneric NameHYDROCODONE BITARTRATE AND ACETAMINOPHENManufacturers Eywa Pharma Inc, Tris Pharma Inc, Novel Laboratories, Inc., Epic Pharma, LLC, Am ... product_ndc 71930-027, 27808-035, 27808-036, 27808-037, 40032-356, 40032-358, 40032-357, 428 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsACETAMINOPHEN, HYDROCODONE BITARTRATERXCUI856940, 856999, 857002, 857005, 856987, 856980, 856992, 1044427, 857391, 1442445spl_id 6b16103c-b56a-461d-9875-b7eeb31411f6, 8ea12d79-1c1f-4c5e-a611-475226dd0285, 102f ... spl_set_id adb37532-aa19-48a2-95a1-8c92a6ce8651, d4caec6d-4af2-4f1c-9add-c0c948b83b16, 7a89 ... Package NDC 71930-027-43, 27808-035-01, 27808-035-02, 27808-035-03, 27808-036-01, 27808-036- ... UNII362O9ITL9D, NO70W886KK

53)

drugcharacterization2medicinalproductLEVOFLOXACIN.drugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate12/12/2008

activesubstance

activesubstancenameLEVOFLOXACIN

openFDA Info on Medication

Application Number ANDA090268, ANDA205968, ANDA090343, ANDA206908, ANDA091375, ANDA077438, ANDA0785 ... Brand NameLEVOFLOXACINGeneric NameLEVOFLOXACIN, LEVOFLOXACIN IN 5% DEXTROSEManufacturers Akorn, Cadila Healthcare Limited, Sagent Pharmaceuticals, Gland Pharma Limited, ... product_ndc 17478-106, 70771-1079, 25021-132, 68083-414, 68083-415, 68083-416, 0143-9315, 01 ... Product TypeHUMAN PRESCRIPTION DRUGRouteOPHTHALMIC, INTRAVENOUS, ORALActive IngredientsLEVOFLOXACINRXCUI 314080, 1665517, 1665519, 1665497, 1665507, 1665515, 199884, 199885, 311296, 477 ... spl_id c95440ae-7fb1-4878-bdcd-132029d1d207, aabf0379-95a8-44bd-82e5-787a33a48433, a1a2 ... spl_set_id 6987500a-2feb-48a9-9d29-89693333a801, 74ffa693-6859-4b92-998b-775b3245d45d, 699f ... Package NDC 17478-106-10, 70771-1079-2, 70771-1079-3, 25021-132-81, 25021-132-82, 25021-132- ... NUIN0000175937, M0023650Established Pharmacologic ClassQuinolone Antimicrobial [EPC]Chemical StructureQuinolones [CS]UNII6GNT3Y5LMF

54)

drugcharacterization2medicinalproductLORAZEPAM.drugstructuredosagenumb.5drugstructuredosageunit003drugdosagetext.5 MILLIGRAMdrugdosageformTABLETSdrugadministrationroute065

activesubstance

activesubstancenameLORAZEPAM

openFDA Info on Medication

Application Number ANDA076150, NDA018140, ANDA203572, ANDA074282, ANDA072755, ANDA090260, ANDA07502 ... Brand NameLORAZEPAM, LOREEV XR, ATIVANGeneric NameLORAZEPAMManufacturers International Medication Systems, Limited, Hikma Pharmaceuticals USA Inc., Aurol ... product_ndc 76329-8261, 0641-6207, 13107-083, 13107-084, 13107-085, 0409-6778, 0054-3532, 01 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsLORAZEPAMRXCUI 238100, 197900, 197901, 197902, 1665188, 311376, 238101, 1665326, 2569564, 25695 ... spl_id 8b30da4f-e5a1-4e8a-9971-b5c687508d81, 4f2988b1-2854-4051-962f-07cc925608ab, 66ed ... spl_set_id 7dda070d-7809-46c4-8592-eb4e4c509707, b79b38ee-c29d-4099-964f-000031f47f5a, 5b85 ... Package NDC 76329-8261-1, 0641-6207-01, 0641-6207-25, 13107-083-11, 13107-083-01, 13107-083- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIO26FZP769L

55)

drugcharacterization2medicinalproductPOTASSIUM CHLORIDE.drugstructuredosagenumb20drugstructuredosageunit029drugdosageformTABLETSdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate07/05/2014

activesubstance

activesubstancenamePOTASSIUM CHLORIDE

openFDA Info on Medication

Brand Name KALI MURIATICUM, POTASSIUM CHLORIDE, SORE THROAT 911, POTASSIUM CHLORIDE EXTENDE ... Generic Name POTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASE, POTASSIUM CHLORIDE, DEX ... Manufacturers Hyland's, Camber Pharmaceuticals, Inc., Epic Pharma, LLC, DelCorean, LLC, Actavi ... product_ndc 54973-5224, 31722-133, 31722-134, 31722-135, 42806-094, 35484-204, 62037-559, 62 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, TOPICAL, INTRAVENOUS, PARENTERAL, SUBLINGUALActive IngredientsPOTASSIUM CHLORIDE, POTASSIUM CATION, DEXTROSE MONOHYDRATEspl_id d43e4cfe-351c-7369-e053-2995a90ab722, dd7e7134-d695-4776-92ce-8c940715a702, e172 ... spl_set_id 2e8a4762-d28d-4b64-892f-913e04d18d2d, b1e827aa-b2fb-4fa5-984d-ddd94338ff53, 1373 ... Package NDC 54973-5224-1, 54973-5224-2, 31722-133-01, 31722-133-05, 31722-134-01, 31722-135- ... UNII660YQ98I10, 295O53K152, LX22YL083GApplication Number ANDA214422, ANDA210200, ANDA077419, ANDA209922, ANDA209786, NDA018279, ANDA08020 ... RXCUI 403888, 1801294, 1801298, 1867544, 312504, 315183, 312515, 314182, 198116, 31252 ... NUIM0026737, N0000175600, N0000175811, N0000009371, N0000009726, N0000010288Chemical StructurePotassium Compounds [CS]Established Pharmacologic ClassPotassium Salt [EPC], Osmotic Laxative [EPC]Physiologic/Pharmacodynamic Effect Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Elect ... Mechanism of ActionOsmotic Activity [MoA]

56)

drugcharacterization2medicinalproductFLUARIX QUADdrugstructuredosagenumb60drugstructuredosageunit004drugdosagetext60 MICROGRAMdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat602drugstartdate//2017drugenddateformat602drugenddate//2018

57)

drugcharacterization1medicinalproductREVLIMIDdrugbatchnumbA0201B,UNKNOWN,A0408-01,A2699Adrugauthorizationnumb021880drugstructuredosagenumb25drugstructuredosageunit003drugdosagetext25 MILLIGRAMdrugdosageformCAPSULESdrugadministrationroute048drugindicationPLASMA CELL MYELOMAdrugstartdateformat610drugstartdate/08/2013actiondrug1drugrecurreadministration3

activesubstance

activesubstancenameLENALIDOMIDE

openFDA Info on Medication

Application NumberNDA021880Brand NameREVLIMIDGeneric NameLENALIDOMIDEManufacturersCelgene Corporationproduct_ndc59572-402, 59572-405, 59572-410, 59572-415, 59572-420, 59572-425Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLENALIDOMIDERXCUI 602910, 602912, 616114, 616116, 643712, 643714, 643720, 643722, 1242231, 1242233 ... spl_idab1a612f-883f-4e2d-8015-2efb50b08783spl_set_id5fa97bf5-28a2-48f1-8955-f56012d296bePackage NDC 59572-402-28, 59572-402-00, 59572-405-28, 59572-405-00, 59572-410-28, 59572-410- ... NUIN0000184014Established Pharmacologic ClassThalidomide Analog [EPC]UNIIF0P408N6V4

58)

drugcharacterization2medicinalproductDEXAMETHASONE.drugstructuredosagenumb4drugstructuredosageunit003drugdosagetext40 MILLIGRAMdrugdosageformTABLETSdrugadministrationroute048drugstartdateformat102drugstartdate02/01/2014

activesubstance

activesubstancenameDEXAMETHASONE

openFDA Info on Medication

Application Number NDA022315, ANDA088237, ANDA088481, NDA211379, ANDA215106, ANDA201270, ANDA088254 ... Brand Name OZURDEX, TAPERDEX 12-DAY, DEXAMETHASONE, HEMADY, DEXAMETHASONE 1.5 MG, ZCORT, TA ... Generic NameDEXAMETHASONE, DEXAMETHASONE 1.5 MGManufacturers Allergan, Inc., Xspire Pharma, Llc, Alvogen Inc., Acrotech Biopharma LLC, Fera P ... product_ndc 0023-3348, 42195-149, 42195-490, 47781-914, 47781-916, 72893-015, 48102-047, 481 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVITREAL, ORAL, INTRAOCULAR, OPHTHALMIC, INTRACANALICULARActive IngredientsDEXAMETHASONERXCUI 854177, 854181, 197580, 1943550, 1998481, 197582, 197583, 2261802, 2286261, 1975 ... spl_id 04b2b881-a84c-417c-ba09-8a76cf46faea, 450c31b5-c5c0-44bb-bde5-66748f67b156, 4ce5 ... spl_set_id 4b204f44-6e8a-4d17-803c-268f0b04679f, c3c59b82-1343-470d-bbc7-e40da3c0a28f, 9ab2 ... Package NDC 0023-3348-07, 0023-3348-08, 42195-149-12, 42195-490-12, 47781-914-01, 47781-914- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNII7S5I7G3JQL

59)

drugcharacterization2medicinalproductONDANSETRON HCLdrugstructuredosagenumb8drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext16 MILLIGRAMdrugdosageformTABLETSdrugadministrationroute048drugstartdateformat102drugstartdate12/08/2013

activesubstance

activesubstancenameONDANSETRON HYDROCHLORIDE

openFDA Info on Medication

60)

drugcharacterization2medicinalproductPAMIDRONATEdrugstructuredosagenumb90drugstructuredosageunit003drugdosagetext90 MILLIGRAMdrugdosageformINJECTIONdrugadministrationroute041drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate01/04/2013

activesubstance

activesubstancenamePAMIDRONATE DISODIUM

61)

drugcharacterization2medicinalproductPAMIDRONATEdrugstructuredosagenumb90drugstructuredosageunit003drugdosagetext90 MILLIGRAMdrugdosageformINJECTIONdrugadministrationroute041drugstartdateformat102drugstartdate04/06/2013

activesubstance

activesubstancenamePAMIDRONATE DISODIUM

62)

drugcharacterization2medicinalproductPAMIDRONATEdrugstructuredosagenumb90drugstructuredosageunit003drugdosagetext90 MILLIGRAMdrugdosageformINJECTIONdrugadministrationroute041drugstartdateformat102drugstartdate22/02/2013

activesubstance

activesubstancenamePAMIDRONATE DISODIUM

63)

drugcharacterization2medicinalproductPAMIDRONATEdrugstructuredosagenumb90drugstructuredosageunit003drugdosagetext90 MILLIGRAMdrugdosageformINJECTIONdrugadministrationroute041drugstartdateformat102drugstartdate18/01/2013

activesubstance

activesubstancenamePAMIDRONATE DISODIUM

64)

drugcharacterization2medicinalproductESZOPICLONE.drugstructuredosagenumb2drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 MILLIGRAMdrugdosageformUNKNOWNdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate14/03/2008

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application Number ANDA091124, ANDA091166, ANDA091103, ANDA091113, ANDA091024, ANDA208451, ANDA2029 ... Brand NameESZOPICLONE, LUNESTAGeneric NameESZOPICLONEManufacturers Lupin Pharmaceuticals, Inc., Glenmark Pharmaceuticals Inc. USA, Sun Pharmaceutic ... product_ndc 68180-322, 68180-323, 68180-324, 68462-382, 68462-383, 68462-384, 47335-586, 473 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, OROPHARYNGEALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id c15b2322-c078-46c1-8959-9288faaab19e, 8d6002b1-95d9-445c-8ace-e6dccea36852, 95e9 ... spl_set_id 7068c455-691e-4c56-9857-b7b4e13f4784, 584dc66c-063a-4552-a056-74b811e2bc80, 8bb1 ... Package NDC 68180-322-01, 68180-322-11, 68180-322-13, 68180-323-01, 68180-323-02, 68180-323- ... UNIIUZX80K71OE

65)

drugcharacterization2medicinalproductGUAIFENESIN.drugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate13/04/2010

activesubstance

activesubstancenameGUAIFENESIN

openFDA Info on Medication

Application Number part341, ANDA207342, ANDA209215, ANDA213420, ANDA210453, NDA021282, ANDA091009, ... Brand Name SIMPEX GUAIFENESIN, MUCUS RELIEF, GOOD NEIGHBOR PHARMACY TABTUSSIN, MUCUS RELIEF ... Generic NameGUAIFENESINManufacturers Simpex Pharma Pvt. Ltd, Strategic Sourcing Services LLC, AmerisourceBergen Drug ... product_ndc 76457-004, 70677-0049, 46122-057, 55301-532, 10956-002, 41520-731, 68163-743, 05 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDERXCUI 359601, 636522, 310604, 213160, 310621, 197741, 198687, 310625, 891301, 1112205, ... spl_id 7d870204-c1ad-fa24-e053-2a91aa0a2be6, 9148996d-3708-4b7f-a08c-f5abdf2ab624, 31a9 ... spl_set_id 1594f9d6-0c48-42bf-b76b-d621f215179a, 2200cd7d-3611-4413-9ce3-91fdac9c76c2, 3cab ... Package NDC 76457-004-00, 70677-0049-1, 46122-057-62, 55301-532-11, 10956-002-60, 41520-731- ... NUIN0000193956, N0000008867, N0000009560Established Pharmacologic ClassExpectorant [EPC]Physiologic/Pharmacodynamic Effect Decreased Respiratory Secretion Viscosity [PE], Increased Respiratory Secretions ... UNII495W7451VQ, 9D2RTI9KYH

66)

drugcharacterization2medicinalproductLANSOPRAZOLE.drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformUNKNOWNdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameLANSOPRAZOLE

openFDA Info on Medication

Application Number ANDA202319, ANDA203187, ANDA202366, NDA208025, ANDA091269, ANDA210465, ANDA20217 ... Brand Name BASIC CARE LANSOPRAZOLE, EQUALINE LANSOPRAZOLE, HEALTH MART LANSOPRAZOLE, LANSOP ... Generic NameLANSOPRAZOLE, LANSOPRAZOLE DELAYED RELEASEManufacturers Amazon.com Services LLC, Supervalu Inc, Strategic Sourcing Services LLC, Chain D ... product_ndc 72288-343, 41163-117, 62011-0472, 68016-758, 65841-769, 65841-770, 45802-245, 49 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLANSOPRAZOLERXCUI596843, 311277, 351261, 351260, 206205, 206206, 596918, 866152spl_id 618a52b6-812d-412b-8838-b059f8b92d9b, a9daca89-e2f8-40bf-9beb-4267aaac7d3e, 181f ... spl_set_id 6b57eb00-74fd-435f-bd08-086c9f8ac62c, ea8efda5-9d08-446b-9424-68a98122589a, 181f ... Package NDC 72288-343-03, 72288-343-01, 41163-117-01, 41163-117-02, 41163-117-03, 62011-0472 ... NUIN0000175525, N0000000147, N0000009724Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA]Physiologic/Pharmacodynamic EffectInhibition Gastric Acid Secretion [PE]UNII0K5C5T2QPG

67)

drugcharacterization2medicinalproductPROMETHAZINEdrugdosageformUNKNOWNdrugadministrationroute065drugindicationVOMITINGdrugstartdateformat102drugstartdate20/02/2014

activesubstance

activesubstancenamePROMETHAZINE\PROMETHAZINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA040882Brand NamePROMETHAZINE HYDROCHLORIDEGeneric NamePROMETHAZINEManufacturersAmneal Pharmaceuticals LLCproduct_ndc65162-678Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPROMETHAZINE HYDROCHLORIDERXCUI992432spl_id43553934-cb17-455f-bb9a-3f44b9da0cbbspl_set_idafb16e94-03bf-4ea2-b2fe-e65f274e55a9Package NDC65162-678-86, 65162-678-90UNIIR61ZEH7I1I

68)

drugcharacterization2medicinalproductSENNOSIDEdrugstructuredosagenumb8.6drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1-3 TABSdrugdosageformTABLETSdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameSENNOSIDES

69)

drugcharacterization1medicinalproductREVLIMIDdrugbatchnumbA0201B,UNKNOWN,A0408-01,A2699Adrugauthorizationnumb021880drugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MILLIGRAMdrugdosageformCAPSULESdrugadministrationroute048drugstartdateformat102drugstartdate27/09/2018drugenddateformat102drugenddate25/10/2018actiondrug1drugrecurreadministration3

activesubstance

activesubstancenameLENALIDOMIDE

openFDA Info on Medication

Application NumberNDA021880Brand NameREVLIMIDGeneric NameLENALIDOMIDEManufacturersCelgene Corporationproduct_ndc59572-402, 59572-405, 59572-410, 59572-415, 59572-420, 59572-425Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLENALIDOMIDERXCUI 602910, 602912, 616114, 616116, 643712, 643714, 643720, 643722, 1242231, 1242233 ... spl_idab1a612f-883f-4e2d-8015-2efb50b08783spl_set_id5fa97bf5-28a2-48f1-8955-f56012d296bePackage NDC 59572-402-28, 59572-402-00, 59572-405-28, 59572-405-00, 59572-410-28, 59572-410- ... NUIN0000184014Established Pharmacologic ClassThalidomide Analog [EPC]UNIIF0P408N6V4

70)

drugcharacterization2medicinalproductBORTEZOMIB.drugstructuredosagenumb2.8drugstructuredosageunit003drugdosageformINJECTIONdrugadministrationroute058drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate13/08/2013

activesubstance

activesubstancenameBORTEZOMIB

openFDA Info on Medication

Application Number ANDA210824, ANDA210204, NDA209191, ANDA212825, NDA205004, ANDA208392, ANDA209659 ... Brand NameBORTEZOMIB, VELCADEGeneric NameBORTEZOMIB, BORTEXOMIBManufacturers BluePoint Laboratories, Zydus Pharmaceuticals USA Inc., Ingenus Pharmaceuticals, ... product_ndc 68001-540, 70710-1411, 50742-484, 0409-1703, 0409-1704, 55150-337, 63323-721, 51 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, SUBCUTANEOUSActive IngredientsBORTEZOMIBRXCUI402243, 2601542, 2601544, 402244spl_id df1f04a5-b5bc-73e6-e053-2a95a90aa6d4, a22e9a33-0c4c-4e0c-8eaf-991e66c50753, 125f ... spl_set_id 12500f21-8e2f-4bcd-861e-4dfca843da2e, 0eb8daef-18da-43bb-b7c6-38c4c8b5dd80, c9bf ... Package NDC 68001-540-36, 70710-1411-1, 50742-484-01, 0409-1703-01, 0409-1704-01, 55150-337- ... NUIN0000175604, N0000175075Established Pharmacologic ClassProteasome Inhibitor [EPC]Mechanism of ActionProteasome Inhibitors [MoA]UNII69G8BD63PP

71)

drugcharacterization2medicinalproductDEXAMETHASONE.drugstructuredosagenumb4drugstructuredosageunit003drugdosagetext40 MILLIGRAMdrugdosageformTABLETSdrugadministrationroute048drugstartdateformat102drugstartdate03/09/2013

activesubstance

activesubstancenameDEXAMETHASONE

openFDA Info on Medication

Application Number NDA022315, ANDA088237, ANDA088481, NDA211379, ANDA215106, ANDA201270, ANDA088254 ... Brand Name OZURDEX, TAPERDEX 12-DAY, DEXAMETHASONE, HEMADY, DEXAMETHASONE 1.5 MG, ZCORT, TA ... Generic NameDEXAMETHASONE, DEXAMETHASONE 1.5 MGManufacturers Allergan, Inc., Xspire Pharma, Llc, Alvogen Inc., Acrotech Biopharma LLC, Fera P ... product_ndc 0023-3348, 42195-149, 42195-490, 47781-914, 47781-916, 72893-015, 48102-047, 481 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVITREAL, ORAL, INTRAOCULAR, OPHTHALMIC, INTRACANALICULARActive IngredientsDEXAMETHASONERXCUI 854177, 854181, 197580, 1943550, 1998481, 197582, 197583, 2261802, 2286261, 1975 ... spl_id 04b2b881-a84c-417c-ba09-8a76cf46faea, 450c31b5-c5c0-44bb-bde5-66748f67b156, 4ce5 ... spl_set_id 4b204f44-6e8a-4d17-803c-268f0b04679f, c3c59b82-1343-470d-bbc7-e40da3c0a28f, 9ab2 ... Package NDC 0023-3348-07, 0023-3348-08, 42195-149-12, 42195-490-12, 47781-914-01, 47781-914- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNII7S5I7G3JQL

72)

drugcharacterization2medicinalproductOMEPRAZOLE.drugdosageformUNKNOWNdrugadministrationroute065drugstartdateformat102drugstartdate19/03/2014

activesubstance

activesubstancenameOMEPRAZOLE

openFDA Info on Medication

Application Number NDA022032, ANDA210593, ANDA207891, ANDA075410, ANDA206877, ANDA075757, NDA209400 ... Brand Name GOOD NEIGHBOR PHARMACY OMEPRAZOLE, EQUALINE OMEPRAZOLE DELAYED RELEASE, KIRKLAND ... Generic NameOMEPRAZOLE, OMEPRAZOLE MAGNESIUMManufacturers Amerisource Bergen, Supervalu Inc, Costco Wholesale Company, INNOVUS PHARMACEUTI ... product_ndc 46122-281, 41163-614, 63981-915, 57483-740, 51660-029, 62175-114, 62175-118, 621 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE, OMEPRAZOLE MAGNESIUMRXCUI402014, 198051, 199119, 200329, 2003656spl_id f8450f59-9629-41d2-92eb-9ac30593ea31, bd28c8a0-73e5-4c81-bc0e-b2c1504a88c3, 8c9d ... spl_set_id 5ee3cb79-5c0c-456f-b5d5-d5a008bbd118, 16bf0c57-0376-48b3-90e5-502d61d1b6eb, 48a4 ... Package NDC 46122-281-04, 46122-281-74, 41163-614-01, 63981-915-55, 57483-740-01, 57483-740- ... NUIN0000175525, N0000000147, N0000182140Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNIIKG60484QX9, 426QFE7XLK

73)

drugcharacterization2medicinalproductONDANSETRON HCLdrugstructuredosagenumb8drugstructuredosageunit003drugdosageformTABLETSdrugadministrationroute048drugstartdateformat102drugstartdate13/08/2013

activesubstance

activesubstancenameONDANSETRON HYDROCHLORIDE

openFDA Info on Medication

74)

drugcharacterization2medicinalproductONDANSETRON HCLdrugseparatedosagenumb1drugintervaldosageunitnumb6drugintervaldosagedefinition805drugdosageformTABLETSdrugadministrationroute048drugstartdateformat102drugstartdate07/05/2014

activesubstance

activesubstancenameONDANSETRON HYDROCHLORIDE

openFDA Info on Medication

75)

drugcharacterization2medicinalproductPAMIDRONATEdrugstructuredosagenumb90drugstructuredosageunit003drugdosagetext90 MILLIGRAMdrugdosageformINJECTIONdrugadministrationroute041drugstartdateformat102drugstartdate02/07/2013

activesubstance

activesubstancenamePAMIDRONATE DISODIUM

76)

drugcharacterization2medicinalproductSODIUM CHLORIDE.drugdosagetext0.9%drugdosageformINJECTIONdrugadministrationroute041drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate20/08/2013

activesubstance

activesubstancenameSODIUM CHLORIDE

openFDA Info on Medication

Application Number NDA018897, NDA019635, ANDA201833, ANDA201850, part349, NDA016677, ANDA207310, ND ... Brand Name SODIUM CHLORIDE, LICEFREEE EVERYDAY, VORTEX MOISTURIZER NASAL, AQUA MARINA, NATR ... Generic NameSODIUM CHLORIDE, SODIUM CHLORIDE OPHTHALMIC OINTMENTManufacturers Hospira, Inc., B. Braun Medical Inc., Tec Laboratories,Inc., Vortex Life Science ... product_ndc 0409-6660, 0409-6657, 0264-9375, 51879-191, 82529-000, 0641-6144, 0641-0497, 064 ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRoute INTRAVENOUS, TOPICAL, NASAL, INTRAMUSCULAR, SUBCUTANEOUS, ORAL, OPHTHALMIC, IRRI ... Active IngredientsSODIUM CHLORIDERXCUI 1807578, 1807580, 1807637, 707251, 1807636, 313016, 351179, 1298435, 1299626, 26 ... spl_id a1599a5f-a627-426c-a32b-30d7110ac4c6, 7a6642e8-d304-47fc-acd9-0dcac4650f88, cf35 ... spl_set_id 018a8807-1331-41c3-4889-c7ec502a9043, 24a08a93-df23-474b-873e-c59ec8855f9f, 407b ... Package NDC 0409-6657-01, 0409-6657-73, 0409-6660-01, 0409-6660-75, 0264-9375-88, 51879-191- ... UNII451W47IQ8X

77)

drugcharacterization2medicinalproductAMOXICILLIN.drugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 TABLETdrugdosageformTABLETSdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate30/08/2014

activesubstance

activesubstancenameAMOXICILLIN

openFDA Info on Medication

Application Number ANDA065255, ANDA065056, ANDA065271, ANDA065256, ANDA064013, ANDA061926, ANDA0619 ... Brand NameAMOXICILLINGeneric NameAMOXICILLINManufacturers Hikma Pharmaceuticals USA Inc., Teva Pharmaceuticals USA, Inc., NorthStar Rx LLC ... product_ndc 0143-9285, 0093-2263, 0093-2264, 16714-298, 16714-299, 57237-028, 57237-029, 009 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMOXICILLINRXCUI308194, 308192, 308182, 308191, 239191, 308177, 598025, 308189, 313850, 313797spl_id 11f42795-cdea-4c98-a921-2c54e40370ba, 7b44bb9c-2d87-4260-81f1-fea8539749a5, 832f ... spl_set_id c8591c2a-92ef-4432-b19a-bb46063047ee, 20c86622-85b7-4827-a317-57aee79dfe57, 843f ... Package NDC 0143-9285-01, 0143-9285-20, 0093-2263-01, 0093-2264-01, 16714-298-01, 16714-298- ... UNII804826J2HU

78)

drugcharacterization2medicinalproductFLUTICASONE.drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate01/02/2009

activesubstance

activesubstancenameFLUTICASONE

openFDA Info on Medication

Application NumberANDA078492Brand NameFLUTICASONEGeneric NameFLUTICASONE PROPIONATEManufacturersMorton Grove Pharmaceuticals, Inc.product_ndc60432-264Product TypeHUMAN PRESCRIPTION DRUGRouteNASALActive IngredientsFLUTICASONE PROPIONATERXCUI1797907spl_ida9e7f8b6-a38a-4128-b1c8-8a008bd15842spl_set_id7c692ed5-959e-4c48-aeec-0799d8979693Package NDC60432-264-15UNIIO2GMZ0LF5W

79)

drugcharacterization2medicinalproductPROCHLORPERAZINE MALEATE.drugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb6drugintervaldosagedefinition805drugdosagetext40 MILLIGRAMdrugdosageformTABLETSdrugadministrationroute048drugindicationNAUSEAdrugstartdateformat102drugstartdate07/05/2014

activesubstance

activesubstancenamePROCHLORPERAZINE MALEATE

openFDA Info on Medication

Application NumberANDA040185, ANDA040268Brand NamePROCHLORPERAZINE MALEATEGeneric NamePROCHLORPERAZINE MALEATEManufacturersMylan Pharmaceuticals Inc., JUBILANT CADISTA PHARMACEUTICALS INC.product_ndc0378-5105, 0378-5110, 59746-113, 59746-115Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPROCHLORPERAZINE MALEATERXCUI198365, 312635spl_id86370b37-2a3d-4231-92a8-640b467db17d, aeb0f87c-6809-496d-8162-72c2e405bde0spl_set_id6b0e958b-fde0-74ea-b196-1e62f90b5bbe, b05bc20e-cd19-ab40-1ad0-84a115d6d69ePackage NDC 0378-5105-01, 0378-5110-01, 59746-113-06, 59746-113-10, 59746-115-06, 59746-115- ... UNIII1T8O1JTL6

80)

drugcharacterization2medicinalproductSULFAMETHOXAZOLE TRIMETHOPRIMdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate29/05/2014

activesubstance

activesubstancenameSULFAMETHOXAZOLE\TRIMETHOPRIM

openFDA Info on Medication

81)

drugcharacterization2medicinalproductWARFARINdrugstructuredosagenumb12drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext12 MILLIGRAMdrugdosageformUNKNOWNdrugadministrationroute065drugstartdateformat102drugstartdate22/05/2014

activesubstance

activesubstancenameWARFARIN

openFDA Info on Medication

Application NumberANDA090935, ANDA202202Brand NameWARFARIN SODIUMGeneric NameWARFARINManufacturersExelan Pharmaceuticals Inc., Amneal Pharmaceuticals LLCproduct_ndc 76282-327, 76282-328, 76282-329, 76282-330, 76282-331, 76282-332, 76282-333, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsWARFARIN SODIUMRXCUI855288, 855296, 855302, 855312, 855318, 855324, 855332, 855338, 855344spl_id45e85c4e-ae91-4cf3-bd98-1d5b5aecc7c5, 02a5640e-a453-4463-976c-34d448423071spl_set_idc0cc4511-e656-4b6d-96cd-e02e76173b9d, 558b7a0d-5490-4c1b-802e-3ab3f1efe760Package NDC 76282-327-01, 76282-327-10, 76282-328-01, 76282-328-10, 76282-329-01, 76282-329- ... UNII6153CWM0CL

82)

drugcharacterization2medicinalproductWARFARINdrugstructuredosagenumb2drugstructuredosageunit032drugdosageformTABLETSdrugadministrationroute048drugstartdateformat102drugstartdate15/05/2014drugenddateformat102drugenddate15/05/2014

activesubstance

activesubstancenameWARFARIN

openFDA Info on Medication

Application NumberANDA090935, ANDA202202Brand NameWARFARIN SODIUMGeneric NameWARFARINManufacturersExelan Pharmaceuticals Inc., Amneal Pharmaceuticals LLCproduct_ndc 76282-327, 76282-328, 76282-329, 76282-330, 76282-331, 76282-332, 76282-333, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsWARFARIN SODIUMRXCUI855288, 855296, 855302, 855312, 855318, 855324, 855332, 855338, 855344spl_id45e85c4e-ae91-4cf3-bd98-1d5b5aecc7c5, 02a5640e-a453-4463-976c-34d448423071spl_set_idc0cc4511-e656-4b6d-96cd-e02e76173b9d, 558b7a0d-5490-4c1b-802e-3ab3f1efe760Package NDC 76282-327-01, 76282-327-10, 76282-328-01, 76282-328-10, 76282-329-01, 76282-329- ... UNII6153CWM0CL

83)

drugcharacterization2medicinalproductZOLPIDEMdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MILLIGRAMdrugdosageformUNKNOWNdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate21/06/2010

activesubstance

activesubstancenameZOLPIDEM\ZOLPIDEM TARTRATE

openFDA Info on Medication

Application NumberANDA077214Brand NameZOLPIDEMGeneric NameZOLPIDEM TARTRATEManufacturersACI Healthcare USA, Incproduct_ndc71093-155, 71093-156Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsZOLPIDEM TARTRATERXCUI854873, 854876spl_ide4a5e984-a50b-4f1e-a50d-b1acd2b34d52spl_set_id021153ce-fe27-4ed1-8d88-b4157b0ed734Package NDC71093-155-06, 71093-155-04, 71093-156-04, 71093-156-06UNIIWY6W63843K

84)

drugcharacterization2medicinalproductMELPHALAN.drugdosagetextHIGH-DOSEdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat602drugstartdate//2007

activesubstance

activesubstancenameMELPHALAN

openFDA Info on Medication

Application NumberNDA207155, NDA014691, ANDA207809, ANDA203393Brand NameEVOMELA, ALKERAN, MELPHALANGeneric NameMELPHALAN, MELPHALAN USP, 2 MG, MELPHALAN HYDROCHLORIDEManufacturers Acrotech Biopharma LLC, ApoPharma USA, Inc., Alvogen Inc., Fresenius Kabi USA, L ... product_ndc68152-109, 52609-0001, 47781-200, 63323-760, 72893-001Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsMELPHALAN HYDROCHLORIDE, MELPHALANRXCUI311487, 1745090, 105562, 197919spl_id dd7dd217-449f-49aa-b839-eee22d963459, b8048e20-e808-34c5-f821-de0b006fa278, c71c ... spl_set_id c5d68b96-14bd-4605-b6d2-2bf8b0c5ca8a, ff913271-0090-4832-a0fe-5154fe8f97b9, 5bc0 ... Package NDC 68152-109-00, 52609-0001-5, 47781-200-50, 63323-760-20, 63323-761-20, 63323-732- ... UNII1VXP4V453T, Q41OR9510PNUIN0000000236, N0000175558Mechanism of ActionAlkylating Activity [MoA]Established Pharmacologic ClassAlkylating Drug [EPC]

summary

narrativeincludeclinicalCASE EVENT DATE: 20130903