Adverse Event Report

Report

reporttype1Version of Safety Report ID5receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10042120serious1Date Last Updated28/07/2014receiptdateformat102companynumbUS-CELGENEUS-163-POMAL-13123396occurcountryUSseriousnessother1duplicate1Date Received27/03/2014seriousnesshospitalization1transmissiondate26/03/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification1

Patient

Onset Age73Unit of Onset AgeyearsWeight66.24SexFemale

Contents

Reaction

1)

reactionmeddraversionpt17.1ReactionPlasma cell myelomaOutcomeUnknown

2)

reactionmeddraversionpt17.1ReactionPruritusOutcomeUnknown

3)

reactionmeddraversionpt17.1ReactionInterstitial lung diseaseOutcomeRecovered/resolved

4)

reactionmeddraversionpt17.1ReactionOrganising pneumoniaOutcomeUnknown

5)

reactionmeddraversionpt17.1ReactionFatigueOutcomeUnknown

6)

reactionmeddraversionpt17.1ReactionNeuropathy peripheralOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization2medicinalproductKLOR-CONdrugstructuredosagenumb10drugstructuredosageunit029drugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenamePOTASSIUM CHLORIDE

openFDA Info on Medication

Application NumberNDA019123, ANDA209662Brand NameKLOR-CONGeneric NamePOTASSIUM CHLORIDEManufacturersSandoz Inc., Upsher-Smith Laboratories, LLCproduct_ndc66758-110, 66758-160, 0245-5315, 0245-5316, 0245-0360Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPOTASSIUM CHLORIDERXCUI312529, 628953, 628958, 832718, 1867544, 1867547spl_id b6795c1c-762b-4589-a49c-cc2d6854ba65, 0907ea1c-82f3-4ba8-9d1b-3f4fa104d7a2, d947 ... spl_set_id 466170e9-e158-4ccd-b7a3-53dc8c3cd749, 1ff53330-065c-4213-9c0c-ac498621d09d, e61a ... Package NDC 66758-110-06, 66758-110-13, 66758-110-01, 66758-110-05, 66758-160-06, 66758-160- ... UNII660YQ98I10

2)

drugcharacterization2medicinalproductAMLODIPINEdrugstructuredosagenumb2.5drugstructuredosageunit003drugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameAMLODIPINE BESYLATE

openFDA Info on Medication

Application NumberNDA211340Brand NameKATERZIAGeneric NameAMLODIPINEManufacturersAzurity Pharmaceuticals, Inc.product_ndc52652-5001Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMLODIPINE BENZOATERXCUI2184120, 2184126spl_id33926064-be3f-4380-b051-ac4136524317spl_set_iddf673a4d-acb8-444c-a472-c87ab8cbd366Package NDC52652-5001-1UNIIXD75TQ8A2P

3)

drugcharacterization2medicinalproductAMLODIPINEdrugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext5 MILLIGRAMdrugdosageformUNKNOWNdrugadministrationroute065

activesubstance

activesubstancenameAMLODIPINE BESYLATE

openFDA Info on Medication

Application NumberNDA211340Brand NameKATERZIAGeneric NameAMLODIPINEManufacturersAzurity Pharmaceuticals, Inc.product_ndc52652-5001Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMLODIPINE BENZOATERXCUI2184120, 2184126spl_id33926064-be3f-4380-b051-ac4136524317spl_set_iddf673a4d-acb8-444c-a472-c87ab8cbd366Package NDC52652-5001-1UNIIXD75TQ8A2P

4)

drugcharacterization2medicinalproductZOLOFTdrugdosageformUNKNOWNdrugadministrationroute065drugindicationDEPRESSION

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_id665a145d-44fb-4fef-a3c1-2aac26e0715cspl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

5)

drugcharacterization2medicinalproductMETOCLOPRAMIDE.drugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext15 MILLIGRAMdrugdosageformUNKNOWNdrugadministrationroute065drugindicationNAUSEA

activesubstance

activesubstancenameMETOCLOPRAMIDE

openFDA Info on Medication

Application Number ANDA073135, ANDA073118, ANDA204756, ANDA091392, ANDA070184, ANDA072801, ANDA0705 ... Brand NameMETOCLOPRAMIDEGeneric NameMETOCLOPRAMIDE, METOCLOPRAMIDE HYDROCHLORIDEManufacturers Teva Parenteral Medicines, Inc., Hospira, Inc., Heritage Pharmaceuticals Inc. d/ ... product_ndc 0703-4502, 0409-3414, 23155-240, 76045-101, 0093-2203, 0093-2204, 49884-689, 625 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsMETOCLOPRAMIDE HYDROCHLORIDERXCUI311670, 727619, 311666, 311668, 104884spl_id ae01c6cc-859a-4b82-99ba-18738f3081af, d693380f-94fa-46df-ad37-4ecf3c59b8b8, e535 ... spl_set_id cccf04bd-7463-40b8-a41f-cb1093c358d7, 373ba08b-33ad-49fc-28a7-928e89a65314, 50a3 ... Package NDC 0703-4502-01, 0703-4502-04, 0409-3414-18, 0409-3414-01, 23155-240-32, 23155-240- ... UNIIW1792A2RVD

6)

drugcharacterization2medicinalproductATIVANdrugindicationVOMITING

activesubstance

activesubstancenameLORAZEPAM

openFDA Info on Medication

Application NumberNDA017794, NDA018140Brand NameATIVANGeneric NameLORAZEPAMManufacturersBausch Health US LLC, West-Ward Pharmaceuticals Corp.product_ndc0187-0063, 0187-0064, 0187-0065, 0641-6000, 0641-6001, 0641-6003, 0641-6002Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsLORAZEPAMspl_idb87ffa4d-6634-4d66-a907-3eba6911444c, 30a1b292-640f-477d-b193-f564e84d0436spl_set_id89057c93-8155-4040-acec-64e877bd2b4c, 5fc0e987-61c9-40c4-b0d5-fcea07c8733ePackage NDC 0187-0063-01, 0187-0063-50, 0187-0063-10, 0187-0064-01, 0187-0064-50, 0187-0064- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIO26FZP769LRXCUI206819, 206820, 238100, 238101, 1665188, 1665190, 1665326, 1665327

7)

drugcharacterization2medicinalproductDEXAMETHASONE.drugauthorizationnumb021880drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803drugdosageformUNKNOWNdrugadministrationroute065drugindicationPLASMA CELL MYELOMA

activesubstance

activesubstancenameDEXAMETHASONE

openFDA Info on Medication

Application Number NDA022315, ANDA088237, NDA211379, ANDA201270, ANDA088481, ANDA088254, NDA208912, ... Brand Name OZURDEX, TAPERDEX 12-DAY, HEMADY, DEXABLISS, DEXAMETHASONE, DEXAMETHASONE 1.5 MG ... Generic NameDEXAMETHASONE, DEXAMETHASONE 1.5 MGManufacturers Allergan, Inc., Xspire Pharma, Llc, Acrotech Biopharma LLC, Levins Pharmaceutica ... product_ndc 0023-3348, 42195-149, 42195-490, 72893-015, 71905-400, 48102-045, 48102-046, 481 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVITREAL, ORAL, INTRAOCULAR, OPHTHALMIC, INTRACANALICULARActive IngredientsDEXAMETHASONERXCUI 854177, 854181, 197580, 1943550, 1998481, 2261802, 2286261, 2121587, 197577, 197 ... spl_id 04b2b881-a84c-417c-ba09-8a76cf46faea, dff2b4b8-6dba-4bf3-ac9d-3960db623d1b, 20ec ... spl_set_id 4b204f44-6e8a-4d17-803c-268f0b04679f, c3c59b82-1343-470d-bbc7-e40da3c0a28f, aec6 ... Package NDC 0023-3348-07, 0023-3348-08, 42195-149-12, 42195-490-12, 72893-015-24, 72893-015- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNII7S5I7G3JQL

8)

drugcharacterization2medicinalproductZOMETAdrugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition802drugdosageformUNKNOWNdrugadministrationroute065drugindicationHYPERCALCAEMIA

activesubstance

activesubstancenameZOLEDRONIC ACID

9)

drugcharacterization2medicinalproductVANCOMYCINdrugdosageformINJECTIONdrugadministrationroute041drugindicationCLOSTRIDIUM DIFFICILE INFECTIONdrugstartdateformat102drugstartdate03/04/2014

activesubstance

activesubstancenameVANCOMYCIN

openFDA Info on Medication

Application NumberANDA205694, ANDA200837, NDA211962Brand NameVANCOMYCIN HYDROCHLORIDE, VANCOMYCINGeneric NameVANCOMYCIN, VANCOMYCIN HYDROCHLORIDEManufacturers Breckenridge Pharmaceutical, Inc., Sagent Pharmaceuticals, Xellia Pharmaceutical ... product_ndc 51991-940, 51991-941, 25021-157, 25021-158, 70594-041, 70594-042, 70594-043, 705 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsVANCOMYCIN HYDROCHLORIDE, VANCOMYCINRXCUI 1807513, 1807516, 239209, 313572, 1807508, 1807510, 1807511, 2118448, 2118449, 2 ... spl_id d5cc977d-305b-46da-ae64-d8351426886b, c3aa75ec-442d-4607-aa80-6df21d09edd7, a9c3 ... spl_set_id 66a6da21-7cd7-4932-86e0-0614f2ec1a93, 06dcfd36-942f-4752-86ad-4c5a6fc3e48f, 60be ... Package NDC 51991-940-99, 51991-940-17, 51991-941-99, 51991-941-17, 25021-157-99, 25021-158- ... UNII71WO621TJD, 6Q205EH1VUNUIN0000175491, M0009481Established Pharmacologic ClassGlycopeptide Antibacterial [EPC]Chemical StructureGlycopeptides [CS]

10)

drugcharacterization2medicinalproductALOXIdrugdosageformUNKNOWNdrugadministrationroute065drugindicationNAUSEA

activesubstance

activesubstancenamePALONOSETRON HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA022233, NDA021372Brand NameALOXIGeneric NamePALONOSETRON HYDROCHLORIDEManufacturersHelsinn Therapeutics (U.S.), Inc., Eisai Inc.product_ndc69639-104, 69639-103, 62856-797, 62856-798Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsPALONOSETRON HYDROCHLORIDERXCUI805448, 805451, 1728050, 1728052, 1728055, 1728056spl_id 327cc7a4-5261-49cc-9e30-e7fffc9662ee, aa0673c1-6011-4162-9795-ddb7607f40b0, afcf ... spl_set_id ab89d423-4275-4651-9ae7-9002f17ab0a1, 795f386e-2b44-5092-e053-2991aa0a5820, 1b51 ... Package NDC69639-104-05, 69639-103-01, 69639-103-05, 62856-797-01, 62856-798-01UNII23310D4I19

11)

drugcharacterization2medicinalproductZOFRANdrugindicationVOMITING

activesubstance

activesubstancenameONDANSETRON HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020103Brand NameZOFRANGeneric NameONDANSETRON HYDROCHLORIDEManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0675, 0078-0676Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsONDANSETRON HYDROCHLORIDERXCUI104895, 104896, 198052, 312086spl_id5de8b98b-16d8-4540-8991-ebaace847a66spl_set_id555f81bc-4ce0-4f77-b394-b974838c4440Package NDC0078-0675-15, 0078-0676-15UNIINMH84OZK2B

12)

drugcharacterization2medicinalproductDEXAMETHASONE.drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803drugdosageformUNKNOWNdrugadministrationroute065drugstartdateformat610drugstartdate/10/2013

activesubstance

activesubstancenameDEXAMETHASONE

openFDA Info on Medication

Application Number NDA022315, ANDA088237, NDA211379, ANDA201270, ANDA088481, ANDA088254, NDA208912, ... Brand Name OZURDEX, TAPERDEX 12-DAY, HEMADY, DEXABLISS, DEXAMETHASONE, DEXAMETHASONE 1.5 MG ... Generic NameDEXAMETHASONE, DEXAMETHASONE 1.5 MGManufacturers Allergan, Inc., Xspire Pharma, Llc, Acrotech Biopharma LLC, Levins Pharmaceutica ... product_ndc 0023-3348, 42195-149, 42195-490, 72893-015, 71905-400, 48102-045, 48102-046, 481 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVITREAL, ORAL, INTRAOCULAR, OPHTHALMIC, INTRACANALICULARActive IngredientsDEXAMETHASONERXCUI 854177, 854181, 197580, 1943550, 1998481, 2261802, 2286261, 2121587, 197577, 197 ... spl_id 04b2b881-a84c-417c-ba09-8a76cf46faea, dff2b4b8-6dba-4bf3-ac9d-3960db623d1b, 20ec ... spl_set_id 4b204f44-6e8a-4d17-803c-268f0b04679f, c3c59b82-1343-470d-bbc7-e40da3c0a28f, aec6 ... Package NDC 0023-3348-07, 0023-3348-08, 42195-149-12, 42195-490-12, 72893-015-24, 72893-015- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNII7S5I7G3JQL

13)

drugcharacterization2medicinalproductACYCLOVIR.drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext400drugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameACYCLOVIR

openFDA Info on Medication

Application Number ANDA206535, ANDA205469, ANDA212495, ANDA203834, ANDA208702, ANDA205510, NDA01860 ... 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, 31722-968, 31722-777, 31722-778, 45802-044, 16 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, TOPICAL, ORAL, CUTANEOUS, BUCCALActive IngredientsACYCLOVIR SODIUM, ACYCLOVIRRXCUI 1734932, 1734934, 197312, 197311, 197313, 141859, 197310, 307730, 2263503, 22635 ... spl_id 48084d23-30e1-4648-875d-8068ec3a7b57, 318fdb7d-10d9-49cf-bbd1-0a7480b962d9, 8a72 ... spl_set_id 69a98000-adef-4323-89a7-09e035a257d4, 962b2e1a-ba9d-4b39-b6d1-203947166482, bedf ... 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 ...

14)

drugcharacterization2medicinalproductAMLODIPINEdrugstructuredosagenumb.25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext.25 MILLIGRAMdrugdosageformUNKNOWNdrugadministrationroute065

activesubstance

activesubstancenameAMLODIPINE BESYLATE

openFDA Info on Medication

Application NumberNDA211340Brand NameKATERZIAGeneric NameAMLODIPINEManufacturersAzurity Pharmaceuticals, Inc.product_ndc52652-5001Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMLODIPINE BENZOATERXCUI2184120, 2184126spl_id33926064-be3f-4380-b051-ac4136524317spl_set_iddf673a4d-acb8-444c-a472-c87ab8cbd366Package NDC52652-5001-1UNIIXD75TQ8A2P

15)

drugcharacterization2medicinalproductMETRONIDAZOLE.drugdosageformINJECTIONdrugadministrationroute041drugindicationCLOSTRIDIUM DIFFICILE INFECTION

activesubstance

activesubstancenameMETRONIDAZOLE

openFDA Info on Medication

Application Number ANDA077264, ANDA077549, ANDA070772, NDA020208, NDA018657, ANDA070027, ANDA070033 ... Brand Name METRONIDAZOLE, ROSADAN, FLAGYL, METRONIDAZOLE 500 MG, METRONIDAZOLE TOPICAL GEL, ... Generic NameMETRONIDAZOLEManufacturers Sandoz Inc., Cosette Pharmaceuticals, Inc., AMICI PHARMACEUTICALS LLC, Oceanside ... product_ndc 0781-7077, 0713-0757, 69292-208, 68682-455, 0338-1055, 50111-333, 50111-334, 516 ... Product TypeHUMAN PRESCRIPTION DRUGRouteVAGINAL, TOPICAL, ORAL, INTRAVENOUSActive IngredientsMETRONIDAZOLERXCUI 142046, 311678, 311681, 311683, 314106, 311679, 199055, 1148398, 207287, 207290, ... spl_id a00b814a-ba5f-4af8-b50d-fa231339148b, 7c04e645-f7ea-4931-9451-05bd8d55bece, 3fe7 ... spl_set_id 0030514f-879d-416d-b422-24b67e334b36, 5a7065b2-e729-46d5-8da5-865dc1ea58f7, 9f1f ... Package NDC 0781-7077-87, 0713-0757-37, 69292-208-01, 69292-208-50, 68682-455-70, 0338-1055- ... NUIN0000175435, M0014907Established Pharmacologic ClassNitroimidazole Antimicrobial [EPC]Chemical StructureNitroimidazoles [CS]UNII140QMO216E

16)

drugcharacterization2medicinalproductTIMOLOL MALEATE.drugstructuredosagenumb.5drugstructuredosageunit030drugdosageformUNKNOWNdrugadministrationroute065drugindicationVOMITING

activesubstance

activesubstancenameTIMOLOL MALEATE

openFDA Info on Medication

Application Number NDA019463, ANDA204936, NDA020330, NDA021516, ANDA074261, ANDA074262, NDA020963, ... Brand Name TIMOPTIC IN OCUDOSE, TIMOLOL MALEATE, TIMOPTIC-XE, ISTALOL, TIMOLOL GFS, TIMOPTI ... Generic NameTIMOLOL MALEATE, TIMOLOLManufacturers Bausch Health US LLC, Apotex Corp, Bausch & Lomb Incorporated, Sandoz Inc, Ocean ... product_ndc 0187-1496, 0187-1498, 60505-1005, 24208-814, 24208-816, 24208-004, 61314-226, 61 ... Product TypeHUMAN PRESCRIPTION DRUGRouteOPHTHALMIC, ORALActive IngredientsTIMOLOL MALEATE, TIMOLOLRXCUI 1922876, 1922877, 1922894, 1922895, 1992299, 313407, 313408, 861420, 861422, 199 ... spl_id c8e75822-985a-47a4-a5b2-baee3c6a7e22, c6bed03c-a758-1ab5-5c36-f6b61b4c5f01, f0a5 ... spl_set_id c1293d51-b633-486c-8e13-fcf60063faeb, df10af59-3b72-ca33-fd89-d9fcd0d61e9b, a4d0 ... Package NDC 0187-1498-25, 0187-1496-05, 0187-1496-99, 60505-1005-1, 60505-1005-4, 24208-814- ... UNIIP8Y54F701R, 817W3C6175

17)

drugcharacterization2medicinalproductOMEPRAZOLE.drugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext20 MILLIGRAMdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameOMEPRAZOLE

openFDA Info on Medication

Application Number NDA022032, ANDA210593, ANDA207891, ANDA075410, ANDA075757, ANDA206877, NDA209400 ... Brand Name GOOD NEIGHBOR PHARMACY OMEPRAZOLE, KIRKLAND SIGNATURE OMEPRAZOLE, OMEPRAZOLE, AC ... Generic NameOMEPRAZOLE, OMEPRAZOLE MAGNESIUMManufacturers Amerisource Bergen, Costco Wholesale Company, INNOVUS PHARMACEUTICALS, INC., OHM ... product_ndc 46122-281, 63981-915, 57483-740, 51660-029, 62175-114, 62175-118, 62175-136, 078 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE, OMEPRAZOLE MAGNESIUMRXCUI402014, 198051, 199119, 200329, 2003656spl_id f8450f59-9629-41d2-92eb-9ac30593ea31, 8c9d9c38-9da6-4f99-9f08-26ec4693fa55, ce5c ... spl_set_id 5ee3cb79-5c0c-456f-b5d5-d5a008bbd118, 48a44d0c-3502-430b-8b75-188a49d14da2, ce5c ... Package NDC 46122-281-04, 46122-281-74, 63981-915-55, 57483-740-01, 57483-740-42, 51660-029- ... NUIN0000175525, N0000000147, N0000182140Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNIIKG60484QX9, 426QFE7XLK

18)

drugcharacterization2medicinalproductOMEPRAZOLE.drugindicationVOMITING

activesubstance

activesubstancenameOMEPRAZOLE

openFDA Info on Medication

Application Number NDA022032, ANDA210593, ANDA207891, ANDA075410, ANDA075757, ANDA206877, NDA209400 ... Brand Name GOOD NEIGHBOR PHARMACY OMEPRAZOLE, KIRKLAND SIGNATURE OMEPRAZOLE, OMEPRAZOLE, AC ... Generic NameOMEPRAZOLE, OMEPRAZOLE MAGNESIUMManufacturers Amerisource Bergen, Costco Wholesale Company, INNOVUS PHARMACEUTICALS, INC., OHM ... product_ndc 46122-281, 63981-915, 57483-740, 51660-029, 62175-114, 62175-118, 62175-136, 078 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE, OMEPRAZOLE MAGNESIUMRXCUI402014, 198051, 199119, 200329, 2003656spl_id f8450f59-9629-41d2-92eb-9ac30593ea31, 8c9d9c38-9da6-4f99-9f08-26ec4693fa55, ce5c ... spl_set_id 5ee3cb79-5c0c-456f-b5d5-d5a008bbd118, 48a44d0c-3502-430b-8b75-188a49d14da2, ce5c ... Package NDC 46122-281-04, 46122-281-74, 63981-915-55, 57483-740-01, 57483-740-42, 51660-029- ... NUIN0000175525, N0000000147, N0000182140Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNIIKG60484QX9, 426QFE7XLK

19)

drugcharacterization2medicinalproductERGOCALCIFEROL.drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2000 UNITSdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameERGOCALCIFEROL

openFDA Info on Medication

Application NumberANDA090455, NDA003444, ANDA091004, ANDA080704, ANDA040833Brand NameVITAMIN D, DRISDOL, ERGOCALCIFEROLGeneric NameERGOCALCIFEROLManufacturers Strides Pharma Science Limited, Validus Pharmaceuticals LLC, Rising Pharamceutic ... product_ndc64380-737, 30698-493, 64980-157, 69452-151, 62332-464Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERGOCALCIFEROLRXCUI1367410, 1367416spl_id 08a99dff-5765-49b0-b289-4e854d3c6725, 9ffcac9b-b70e-40ec-a258-9d739771bdba, 7ce9 ... spl_set_id 2c4c0a36-12cf-444d-9d57-de983eef4d36, acb61678-d23d-405d-8c14-1a16cfd3a776, 9f9e ... Package NDC 64380-737-06, 64380-737-25, 30698-493-01, 64980-157-01, 69452-151-20, 62332-464- ... NUIM0007651, N0000175909Chemical StructureErgocalciferols [CS]Established Pharmacologic ClassProvitamin D2 Compound [EPC]UNIIVS041H42XC

20)

drugcharacterization2medicinalproductPROTONIXdrugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext80 MILLIGRAMdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenamePANTOPRAZOLE SODIUM

openFDA Info on Medication

Application NumberNDA020988, NDA020987, NDA022020Brand NamePROTONIX I.V., PROTONIX DELAYED-RELEASEGeneric NamePANTOPRAZOLE SODIUMManufacturersWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.product_ndc0008-0923, 0008-2001, 0008-4001, 0008-0841, 0008-0843, 0008-0844Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsPANTOPRAZOLE SODIUMRXCUI283669, 885257, 251872, 284400, 314200, 352125, 763306, 763308spl_id b326d5db-8b20-4ec4-ac25-78190fb3ac36, 1e8fa399-506d-4bcd-9097-dbf7850147bf, 7bdf ... spl_set_id 51e4144a-489e-436c-609a-39305f8f56ba, 5b5ddedd-d429-41a7-8573-10c3e9ad4e52, f39b ... Package NDC 0008-0923-51, 0008-0923-60, 0008-0923-55, 0008-2001-01, 0008-2001-25, 0008-2001- ... UNII6871619Q5X

21)

drugcharacterization2medicinalproductMIRALAXdrugstructuredosagenumb17drugstructuredosageunit002drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext17 GRAMdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenamePOLYETHYLENE GLYCOL 3350

openFDA Info on Medication

Application NumberNDA022015Brand NameMIRALAXGeneric NamePOLYETHYLENE GLYCOL 3350ManufacturersBayer HealthCare LLC.product_ndc11523-4357, 11523-7268, 11523-7234, 11523-7341Product TypeHUMAN OTC DRUGRouteORALActive IngredientsPOLYETHYLENE GLYCOL 3350RXCUI876193, 876195spl_idb1cc7dea-6153-4b82-e053-2995a90a62a7spl_set_idd69ce3d4-7ca4-4fe3-b49e-6655e48d6963Package NDC 11523-7268-3, 11523-7268-8, 11523-7268-7, 11523-7268-4, 11523-7268-9, 11523-7234 ... NUIN0000010288, N0000175811, N0000009871Mechanism of ActionOsmotic Activity [MoA]Established Pharmacologic ClassOsmotic Laxative [EPC]Physiologic/Pharmacodynamic EffectStimulation Large Intestine Fluid/Electrolyte Secretion [PE]UNIIG2M7P15E5P

22)

drugcharacterization2medicinalproductHYDROCODONE ACETAMINOPHENdrugseparatedosagenumb1drugintervaldosageunitnumb6drugintervaldosagedefinition805drugdosagetext7.5/325drugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameACETAMINOPHEN\HYDROCODONE BITARTRATE

23)

drugcharacterization2medicinalproductMILK OF MAGNESIAdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameMAGNESIUM HYDROXIDE

openFDA Info on Medication

Application Numberpart334, part331Brand NameMILK OF MAGNESIAGeneric NameMAGNESIUM HYDROXIDE, MILK OF MAGNESIAManufacturers RITE AID PHARMACY, Major Pharmaceuticals, DOLGENCORP, INC., Aurohealth LLC, Meij ... product_ndc 11822-3329, 0904-6756, 55910-649, 58602-321, 41250-949, 37808-064, 72036-005, 30 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsMAGNESIUM HYDROXIDERXCUI253017, 314087, 307675, 1049906spl_id 98cfd7f0-7e1d-2444-e053-2a95a90af737, 35de3bdb-d476-4bd2-9d36-666f6c6ecb53, bad8 ... spl_set_id 5fb30d6d-b82c-1955-e053-2991aa0ab8cd, 35de3bdb-d476-4bd2-9d36-666f6c6ecb53, b699 ... Package NDC 11822-3329-8, 0904-6756-14, 55910-649-12, 58602-321-16, 58602-321-32, 41250-949- ... UNIINBZ3QY004S, 362O9ITL9D, TC2D6JAD40

24)

drugcharacterization2medicinalproductSENOKOT-SdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameDOCUSATE SODIUM\SENNOSIDES

openFDA Info on Medication

Application Numberpart334Brand NameSENOKOT-SGeneric NameSTANDARDIZED SENNA CONCENTRATE AND DOCUSATE SODIUMManufacturersAvrio Health L.P.product_ndc67618-310Product TypeHUMAN OTC DRUGRouteORALActive IngredientsSENNOSIDES, DOCUSATE SODIUMRXCUI998740, 1248015spl_id2ed0b313-850e-d3fa-c1d4-cf9f98238739spl_set_idc24cdc5e-62e0-41a6-8afb-512202a569f4Package NDC67618-310-01, 67618-310-30, 67618-310-60UNII3FYP5M0IJX, F05Q2T2JA0

25)

drugcharacterization2medicinalproductALOXIdrugindicationVOMITING

activesubstance

activesubstancenamePALONOSETRON HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA022233, NDA021372Brand NameALOXIGeneric NamePALONOSETRON HYDROCHLORIDEManufacturersHelsinn Therapeutics (U.S.), Inc., Eisai Inc.product_ndc69639-104, 69639-103, 62856-797, 62856-798Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsPALONOSETRON HYDROCHLORIDERXCUI805448, 805451, 1728050, 1728052, 1728055, 1728056spl_id 327cc7a4-5261-49cc-9e30-e7fffc9662ee, aa0673c1-6011-4162-9795-ddb7607f40b0, afcf ... spl_set_id ab89d423-4275-4651-9ae7-9002f17ab0a1, 795f386e-2b44-5092-e053-2991aa0a5820, 1b51 ... Package NDC69639-104-05, 69639-103-01, 69639-103-05, 62856-797-01, 62856-798-01UNII23310D4I19

26)

drugcharacterization2medicinalproductZOFRANdrugdosageformUNKNOWNdrugadministrationroute065drugindicationNAUSEA

activesubstance

activesubstancenameONDANSETRON HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020103Brand NameZOFRANGeneric NameONDANSETRON HYDROCHLORIDEManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0675, 0078-0676Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsONDANSETRON HYDROCHLORIDERXCUI104895, 104896, 198052, 312086spl_id5de8b98b-16d8-4540-8991-ebaace847a66spl_set_id555f81bc-4ce0-4f77-b394-b974838c4440Package NDC0078-0675-15, 0078-0676-15UNIINMH84OZK2B

27)

drugcharacterization2medicinalproductAMBIENdrugindicationVOMITING

activesubstance

activesubstancenameZOLPIDEM TARTRATE

openFDA Info on Medication

Application NumberNDA021774, NDA019908Brand NameAMBIEN CR, AMBIENGeneric NameZOLPIDEM TARTRATEManufacturersSanofi-Aventis U.S. LLCproduct_ndc0024-5501, 0024-5521, 0024-5401, 0024-5421Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsZOLPIDEM TARTRATERXCUI854880, 854882, 854894, 854896, 854873, 854875, 854876, 854878spl_id6c172483-d1e2-4203-8dab-7f8a780a02ad, e932d227-dc7a-405f-855b-4994aabb85f4spl_set_id404c858c-89ac-4c9d-8a96-8702a28e6e76, c36cadf4-65a4-4466-b409-c82020b42452Package NDC 0024-5501-31, 0024-5501-10, 0024-5521-31, 0024-5521-50, 0024-5521-10, 0024-5401- ... UNIIWY6W63843K

28)

drugcharacterization2medicinalproductTIMOLOL MALEATE.drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext0.25drugdosageformEYE DROPSdrugadministrationroute057drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameTIMOLOL MALEATE

openFDA Info on Medication

Application Number NDA019463, ANDA204936, NDA020330, NDA021516, ANDA074261, ANDA074262, NDA020963, ... Brand Name TIMOPTIC IN OCUDOSE, TIMOLOL MALEATE, TIMOPTIC-XE, ISTALOL, TIMOLOL GFS, TIMOPTI ... Generic NameTIMOLOL MALEATE, TIMOLOLManufacturers Bausch Health US LLC, Apotex Corp, Bausch & Lomb Incorporated, Sandoz Inc, Ocean ... product_ndc 0187-1496, 0187-1498, 60505-1005, 24208-814, 24208-816, 24208-004, 61314-226, 61 ... Product TypeHUMAN PRESCRIPTION DRUGRouteOPHTHALMIC, ORALActive IngredientsTIMOLOL MALEATE, TIMOLOLRXCUI 1922876, 1922877, 1922894, 1922895, 1992299, 313407, 313408, 861420, 861422, 199 ... spl_id c8e75822-985a-47a4-a5b2-baee3c6a7e22, c6bed03c-a758-1ab5-5c36-f6b61b4c5f01, f0a5 ... spl_set_id c1293d51-b633-486c-8e13-fcf60063faeb, df10af59-3b72-ca33-fd89-d9fcd0d61e9b, a4d0 ... Package NDC 0187-1498-25, 0187-1496-05, 0187-1496-99, 60505-1005-1, 60505-1005-4, 24208-814- ... UNIIP8Y54F701R, 817W3C6175

29)

drugcharacterization2medicinalproductIRONdrugindicationVOMITING

activesubstance

activesubstancenameIRON

openFDA Info on Medication

Brand NameFERRUM METALLICUM, BILIOUSNESS DIARRHEAGeneric NameIRONManufacturersWashington Homeopathic Products, Boiron, Natural Health Supply, Seroyal USAproduct_ndc 71919-289, 0220-2055, 0220-2085, 0220-2051, 0220-2050, 0220-2047, 64117-791, 022 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsIRONspl_id 7e4e7e58-41be-89a2-e053-2a91aa0a790b, 8591b12c-51c9-9839-e053-2a91aa0aa937, 8737 ... spl_set_id bbca0ba2-37e5-4667-80ff-365490b25624, 8591b12c-51c8-9839-e053-2a91aa0aa937, 8737 ... Package NDC 71919-289-07, 71919-289-08, 71919-289-09, 71919-289-10, 0220-2055-41, 0220-2085- ... UNIIE1UOL152H7

30)

drugcharacterization2medicinalproductCALCITRIOL.drugstructuredosagenumb.25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext.25 MILLIGRAMdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameCALCITRIOL

openFDA Info on Medication

Application Number ANDA091174, ANDA078066, NDA022087, ANDA204556, ANDA203289, ANDA075765, ANDA09135 ... Brand NameCALCITRIOL, VECTICAL, ROCALTROLGeneric NameCALCITRIOL, CALCITRIOL CAPSULES 0.25 MCG, CALCITRIOL CAPSULES 0.5 MCGManufacturers BIONPHARMA INC., Akorn, Inc., Galderma Laboratories, L.P., Sun Pharmaceutical In ... product_ndc 69452-207, 69452-208, 17478-931, 17478-932, 0299-2012, 62756-967, 62756-968, 651 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUS, TOPICALActive IngredientsCALCITRIOLRXCUI308867, 308868, 308869, 308870, 388517, 883358, 313932, 209006, 209007, 261283spl_id 626f23d5-31e6-41ca-a696-191a4f2bc7ef, 4b9bfbb8-18d0-4bd5-865e-2c5c307b3226, 1ece ... spl_set_id 626f23d5-31e6-41ca-a696-191a4f2bc7ef, 4d6046c2-4a28-47b1-9bb4-51fadeded2d2, a156 ... Package NDC 69452-207-13, 69452-207-20, 69452-208-13, 69452-208-20, 17478-931-01, 17478-932- ... NUIM0004229, N0000175908Chemical StructureCholecalciferol [CS]Established Pharmacologic ClassVitamin D3 Analog [EPC]UNIIFXC9231JVH

31)

drugcharacterization2medicinalproductEMENDdrugdosageformUNKNOWNdrugadministrationroute065drugindicationNAUSEA

activesubstance

activesubstancenameAPREPITANT

openFDA Info on Medication

Application NumberNDA021549, NDA207865, NDA022023Brand NameEMENDGeneric NameAPREPITANT, FOSAPREPITANT DIMEGLUMINEManufacturersMerck Sharp & Dohme Corp.product_ndc0006-0461, 0006-0462, 0006-3862, 0006-0464, 0006-3066, 0006-3061Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsAPREPITANT, FOSAPREPITANT DIMEGLUMINEspl_id 37a3748d-3a29-4193-bf8a-4656c0ddc653, 496bae2e-7001-4e30-91fb-66118721cc0c, 36e0 ... spl_set_id 696f9e80-9cae-403b-de9e-078343ce4713, d4bad03f-29c7-4915-9a88-ec24955e0680, a74d ... Package NDC 0006-0461-02, 0006-0461-01, 0006-0461-06, 0006-0461-12, 0006-0462-01, 0006-0462- ... NUIN0000010262, N0000175786, N0000182141, N0000185507, N0000185506Mechanism of Action Neurokinin 1 Antagonists [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome ... Established Pharmacologic ClassSubstance P/Neurokinin-1 Receptor Antagonist [EPC]UNII1NF15YR6UY, D35FM8T64XRXCUI1731077, 1731082

32)

drugcharacterization2medicinalproductEMENDdrugindicationVOMITING

activesubstance

activesubstancenameAPREPITANT

openFDA Info on Medication

Application NumberNDA021549, NDA207865, NDA022023Brand NameEMENDGeneric NameAPREPITANT, FOSAPREPITANT DIMEGLUMINEManufacturersMerck Sharp & Dohme Corp.product_ndc0006-0461, 0006-0462, 0006-3862, 0006-0464, 0006-3066, 0006-3061Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsAPREPITANT, FOSAPREPITANT DIMEGLUMINEspl_id 37a3748d-3a29-4193-bf8a-4656c0ddc653, 496bae2e-7001-4e30-91fb-66118721cc0c, 36e0 ... spl_set_id 696f9e80-9cae-403b-de9e-078343ce4713, d4bad03f-29c7-4915-9a88-ec24955e0680, a74d ... Package NDC 0006-0461-02, 0006-0461-01, 0006-0461-06, 0006-0461-12, 0006-0462-01, 0006-0462- ... NUIN0000010262, N0000175786, N0000182141, N0000185507, N0000185506Mechanism of Action Neurokinin 1 Antagonists [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome ... Established Pharmacologic ClassSubstance P/Neurokinin-1 Receptor Antagonist [EPC]UNII1NF15YR6UY, D35FM8T64XRXCUI1731077, 1731082

33)

drugcharacterization2medicinalproductVANCOMYCINdrugstructuredosagenumb125drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext125 MILLIGRAMdrugdosageformUNKNOWNdrugadministrationroute065

activesubstance

activesubstancenameVANCOMYCIN

openFDA Info on Medication

Application NumberANDA205694, ANDA200837, NDA211962Brand NameVANCOMYCIN HYDROCHLORIDE, VANCOMYCINGeneric NameVANCOMYCIN, VANCOMYCIN HYDROCHLORIDEManufacturers Breckenridge Pharmaceutical, Inc., Sagent Pharmaceuticals, Xellia Pharmaceutical ... product_ndc 51991-940, 51991-941, 25021-157, 25021-158, 70594-041, 70594-042, 70594-043, 705 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsVANCOMYCIN HYDROCHLORIDE, VANCOMYCINRXCUI 1807513, 1807516, 239209, 313572, 1807508, 1807510, 1807511, 2118448, 2118449, 2 ... spl_id d5cc977d-305b-46da-ae64-d8351426886b, c3aa75ec-442d-4607-aa80-6df21d09edd7, a9c3 ... spl_set_id 66a6da21-7cd7-4932-86e0-0614f2ec1a93, 06dcfd36-942f-4752-86ad-4c5a6fc3e48f, 60be ... Package NDC 51991-940-99, 51991-940-17, 51991-941-99, 51991-941-17, 25021-157-99, 25021-158- ... UNII71WO621TJD, 6Q205EH1VUNUIN0000175491, M0009481Established Pharmacologic ClassGlycopeptide Antibacterial [EPC]Chemical StructureGlycopeptides [CS]

34)

drugcharacterization2medicinalproductLIDOCAINE.drugstructuredosagenumb5drugstructuredosageunit030drugdosageformPoultice or Patchdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameLIDOCAINE

openFDA Info on Medication

Application Number ANDA208822, part348, ANDA088586, part346, ANDA040911, ANDA206297, ANDA040433, AN ... Brand Name LIDOCAINE, LIDOCAINE 4% CREAM, DR. RICHS NUMBING, SATOHAP LIDOCAINE 4% PAIN RELI ... Generic Name LIDOCAINE, LIDOCAINE HYDROCHLORIDE, BURN RELIEF, LIDOCAINE HYDROCHLORIDE AND EPI ... Manufacturers VITRUVIAS THERAPEUTICS, Teligent, Inc., GenZ Online LLC, Sato Pharmaceutical Co. ... product_ndc 69680-120, 52565-122, 69191-500, 49873-617, 50488-2004, 63323-201, 63742-002, 65 ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRoute TOPICAL, INFILTRATION, PERINEURAL, PERCUTANEOUS, TRANSDERMAL, EPIDURAL, INTRACAU ... Active Ingredients LIDOCAINE, LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE, EPINEPHRINE BITARTRAT ... RXCUI 1543069, 1421893, 1291672, 1737778, 1010033, 1534792, 1442274, 1011852, 1010895, ... spl_id ae23d0c4-46d6-4941-8ba7-86b40b321d92, cac58d8c-aee5-469e-96d7-77a09ad75dd3, 47f5 ... spl_set_id a10d6d19-a275-483d-bf64-1ead5c30745c, a3216e25-82bb-4905-ac0b-b2ef4aa32ea0, a346 ... Package NDC 69680-120-35, 52565-122-07, 52565-122-15, 52565-122-30, 69191-500-06, 49873-617- ... NUIN0000175682, M0000897, N0000175426, N0000175976Established Pharmacologic ClassAmide Local Anesthetic [EPC], Antiarrhythmic [EPC]Chemical StructureAmides [CS]Physiologic/Pharmacodynamic EffectLocal Anesthesia [PE]UNII98PI200987, V13007Z41A, F5UM2KM3W7, 30Q7KI53AK

35)

drugcharacterization1medicinalproductPOMALYSTdrugbatchnumb00710402drugauthorizationnumb204026drugstructuredosagenumb4drugstructuredosageunit003drugdosagetext4 MILLIGRAMdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPLASMA CELL MYELOMAdrugstartdateformat102drugstartdate21/10/2013actiondrug5drugrecurreadministration3

activesubstance

activesubstancenamePOMALIDOMIDE

openFDA Info on Medication

Application NumberNDA204026Brand NamePOMALYSTGeneric NamePOMALIDOMIDEManufacturersCelgene Corporationproduct_ndc59572-501, 59572-502, 59572-503, 59572-504Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPOMALIDOMIDERXCUI1369718, 1369724, 1369726, 1369728, 1369730, 1369732, 1369734, 1369736spl_id11dd78c3-3991-4a83-ad3e-2f2262d6bd6fspl_set_id2b25ef01-5c9e-11e1-b86c-0800200c9a66Package NDC 59572-501-21, 59572-501-00, 59572-502-21, 59572-502-00, 59572-503-21, 59572-503- ... NUIN0000184014Established Pharmacologic ClassThalidomide Analog [EPC]UNIID2UX06XLB5

36)

drugcharacterization2medicinalproductCALCITRIOL.drugstructuredosagenumb.25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803drugdosagetext.25 MILLIGRAMdrugdosageformUNKNOWNdrugadministrationroute065

activesubstance

activesubstancenameCALCITRIOL

openFDA Info on Medication

Application Number ANDA091174, ANDA078066, NDA022087, ANDA204556, ANDA203289, ANDA075765, ANDA09135 ... Brand NameCALCITRIOL, VECTICAL, ROCALTROLGeneric NameCALCITRIOL, CALCITRIOL CAPSULES 0.25 MCG, CALCITRIOL CAPSULES 0.5 MCGManufacturers BIONPHARMA INC., Akorn, Inc., Galderma Laboratories, L.P., Sun Pharmaceutical In ... product_ndc 69452-207, 69452-208, 17478-931, 17478-932, 0299-2012, 62756-967, 62756-968, 651 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUS, TOPICALActive IngredientsCALCITRIOLRXCUI308867, 308868, 308869, 308870, 388517, 883358, 313932, 209006, 209007, 261283spl_id 626f23d5-31e6-41ca-a696-191a4f2bc7ef, 4b9bfbb8-18d0-4bd5-865e-2c5c307b3226, 1ece ... spl_set_id 626f23d5-31e6-41ca-a696-191a4f2bc7ef, 4d6046c2-4a28-47b1-9bb4-51fadeded2d2, a156 ... Package NDC 69452-207-13, 69452-207-20, 69452-208-13, 69452-208-20, 17478-931-01, 17478-932- ... NUIM0004229, N0000175908Chemical StructureCholecalciferol [CS]Established Pharmacologic ClassVitamin D3 Analog [EPC]UNIIFXC9231JVH

37)

drugcharacterization2medicinalproductMIRTAZAPINE.drugdosageformUNKNOWNdrugadministrationroute065drugindicationDEPRESSION

activesubstance

activesubstancenameMIRTAZAPINE

openFDA Info on Medication

Application Number ANDA076541, ANDA076921, ANDA077376, ANDA205798, ANDA077666, NDA020415, NDA021208 ... Brand NameMIRTAZAPINE, REMERON, REMERONSOLTABGeneric NameMIRTAZAPINEManufacturers Northstar Rx LLC, Aurolife Pharma LLC, Sun Pharmaceutical Industries, Inc., Auro ... product_ndc 16714-706, 16714-707, 16714-708, 16714-709, 13107-001, 13107-031, 13107-003, 131 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMIRTAZAPINERXCUI 311725, 311726, 314111, 476809, 283406, 283407, 283485, 211322, 211323, 261135, ... spl_id 0506d20e-0f1c-4bd5-a298-383279478f20, ae272efb-da52-4ff3-9ea9-353cef42a174, 03b7 ... spl_set_id 0039f505-7cd0-4d79-b5dd-bf2d172571a0, aa05d606-29fd-443e-802b-1d65584d6bb1, f236 ... Package NDC 16714-706-01, 16714-707-01, 16714-708-01, 16714-709-01, 16714-709-02, 13107-001- ... UNIIA051Q2099Q

38)

drugcharacterization2medicinalproductLYRICAdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext150 MILLIGRAMdrugdosageformUNKNOWNdrugadministrationroute065drugindicationNEUROPATHY PERIPHERAL

activesubstance

activesubstancenamePREGABALIN

openFDA Info on Medication

Application NumberNDA021446, NDA022488Brand NameLYRICAGeneric NamePREGABALINManufacturersParke-Davis Div of Pfizer Inc, U.S. Pharmaceuticalsproduct_ndc 0071-1012, 0071-1013, 0071-1014, 0071-1015, 0071-1016, 0071-1017, 0071-1019, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREGABALINRXCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127, 607018, 607020, ... spl_idb9b1285a-2cb3-4789-8b0e-8d5e1b253534, 0fbd5d1f-30cd-464d-a1d6-71e8057a9377spl_set_id60185c88-ecfd-46f9-adb9-b97c6b00a553, ce1a4b9d-3127-4416-8bf2-fee5899fc0baPackage NDC 0071-1012-68, 0071-1013-41, 0071-1013-68, 0071-1014-41, 0071-1014-68, 0071-1015- ... UNII55JG375S6M

39)

drugcharacterization2medicinalproductATIVANdrugdosageformUNKNOWNdrugadministrationroute065drugindicationNAUSEA

activesubstance

activesubstancenameLORAZEPAM

openFDA Info on Medication

Application NumberNDA017794, NDA018140Brand NameATIVANGeneric NameLORAZEPAMManufacturersBausch Health US LLC, West-Ward Pharmaceuticals Corp.product_ndc0187-0063, 0187-0064, 0187-0065, 0641-6000, 0641-6001, 0641-6003, 0641-6002Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsLORAZEPAMspl_idb87ffa4d-6634-4d66-a907-3eba6911444c, 30a1b292-640f-477d-b193-f564e84d0436spl_set_id89057c93-8155-4040-acec-64e877bd2b4c, 5fc0e987-61c9-40c4-b0d5-fcea07c8733ePackage NDC 0187-0063-01, 0187-0063-50, 0187-0063-10, 0187-0064-01, 0187-0064-50, 0187-0064- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIO26FZP769LRXCUI206819, 206820, 238100, 238101, 1665188, 1665190, 1665326, 1665327

40)

drugcharacterization2medicinalproductVANCOMYCINdrugstructuredosagenumb125drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb6drugintervaldosagedefinition805drugdosagetext500 MILLIGRAMdrugdosageformUNKNOWNdrugadministrationroute048drugstartdateformat102drugstartdate04/04/2014drugenddateformat610drugenddate/05/2014

activesubstance

activesubstancenameVANCOMYCIN

openFDA Info on Medication

Application NumberANDA205694, ANDA200837, NDA211962Brand NameVANCOMYCIN HYDROCHLORIDE, VANCOMYCINGeneric NameVANCOMYCIN, VANCOMYCIN HYDROCHLORIDEManufacturers Breckenridge Pharmaceutical, Inc., Sagent Pharmaceuticals, Xellia Pharmaceutical ... product_ndc 51991-940, 51991-941, 25021-157, 25021-158, 70594-041, 70594-042, 70594-043, 705 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsVANCOMYCIN HYDROCHLORIDE, VANCOMYCINRXCUI 1807513, 1807516, 239209, 313572, 1807508, 1807510, 1807511, 2118448, 2118449, 2 ... spl_id d5cc977d-305b-46da-ae64-d8351426886b, c3aa75ec-442d-4607-aa80-6df21d09edd7, a9c3 ... spl_set_id 66a6da21-7cd7-4932-86e0-0614f2ec1a93, 06dcfd36-942f-4752-86ad-4c5a6fc3e48f, 60be ... Package NDC 51991-940-99, 51991-940-17, 51991-941-99, 51991-941-17, 25021-157-99, 25021-158- ... UNII71WO621TJD, 6Q205EH1VUNUIN0000175491, M0009481Established Pharmacologic ClassGlycopeptide Antibacterial [EPC]Chemical StructureGlycopeptides [CS]

41)

drugcharacterization2medicinalproductAMBIENdrugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext5 MILLIGRAMdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameZOLPIDEM TARTRATE

openFDA Info on Medication

Application NumberNDA021774, NDA019908Brand NameAMBIEN CR, AMBIENGeneric NameZOLPIDEM TARTRATEManufacturersSanofi-Aventis U.S. LLCproduct_ndc0024-5501, 0024-5521, 0024-5401, 0024-5421Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsZOLPIDEM TARTRATERXCUI854880, 854882, 854894, 854896, 854873, 854875, 854876, 854878spl_id6c172483-d1e2-4203-8dab-7f8a780a02ad, e932d227-dc7a-405f-855b-4994aabb85f4spl_set_id404c858c-89ac-4c9d-8a96-8702a28e6e76, c36cadf4-65a4-4466-b409-c82020b42452Package NDC 0024-5501-31, 0024-5501-10, 0024-5521-31, 0024-5521-50, 0024-5521-10, 0024-5401- ... UNIIWY6W63843K

42)

drugcharacterization2medicinalproductMETOCLOPRAMIDE.drugindicationVOMITING

activesubstance

activesubstancenameMETOCLOPRAMIDE

openFDA Info on Medication

Application Number ANDA073135, ANDA073118, ANDA204756, ANDA091392, ANDA070184, ANDA072801, ANDA0705 ... Brand NameMETOCLOPRAMIDEGeneric NameMETOCLOPRAMIDE, METOCLOPRAMIDE HYDROCHLORIDEManufacturers Teva Parenteral Medicines, Inc., Hospira, Inc., Heritage Pharmaceuticals Inc. d/ ... product_ndc 0703-4502, 0409-3414, 23155-240, 76045-101, 0093-2203, 0093-2204, 49884-689, 625 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsMETOCLOPRAMIDE HYDROCHLORIDERXCUI311670, 727619, 311666, 311668, 104884spl_id ae01c6cc-859a-4b82-99ba-18738f3081af, d693380f-94fa-46df-ad37-4ecf3c59b8b8, e535 ... spl_set_id cccf04bd-7463-40b8-a41f-cb1093c358d7, 373ba08b-33ad-49fc-28a7-928e89a65314, 50a3 ... Package NDC 0703-4502-01, 0703-4502-04, 0409-3414-18, 0409-3414-01, 23155-240-32, 23155-240- ... UNIIW1792A2RVD

43)

drugcharacterization2medicinalproductIRONdrugstructuredosagenumb325drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext325 MILLIGRAMdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameIRON

openFDA Info on Medication

Brand NameFERRUM METALLICUM, BILIOUSNESS DIARRHEAGeneric NameIRONManufacturersWashington Homeopathic Products, Boiron, Natural Health Supply, Seroyal USAproduct_ndc 71919-289, 0220-2055, 0220-2085, 0220-2051, 0220-2050, 0220-2047, 64117-791, 022 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsIRONspl_id 7e4e7e58-41be-89a2-e053-2a91aa0a790b, 8591b12c-51c9-9839-e053-2a91aa0aa937, 8737 ... spl_set_id bbca0ba2-37e5-4667-80ff-365490b25624, 8591b12c-51c8-9839-e053-2a91aa0aa937, 8737 ... Package NDC 71919-289-07, 71919-289-08, 71919-289-09, 71919-289-10, 0220-2055-41, 0220-2085- ... UNIIE1UOL152H7

44)

drugcharacterization2medicinalproductRAGLANdrugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext15 MILLIGRAMdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

45)

drugcharacterization1medicinalproductPOMALYSTdrugbatchnumb00710402drugstructuredosagenumb3drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext3 MILLIGRAMdrugdosageformUNKNOWNdrugadministrationroute065drugstartdateformat610drugstartdate/12/2013actiondrug5drugrecurreadministration3

activesubstance

activesubstancenamePOMALIDOMIDE

openFDA Info on Medication

Application NumberNDA204026Brand NamePOMALYSTGeneric NamePOMALIDOMIDEManufacturersCelgene Corporationproduct_ndc59572-501, 59572-502, 59572-503, 59572-504Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPOMALIDOMIDERXCUI1369718, 1369724, 1369726, 1369728, 1369730, 1369732, 1369734, 1369736spl_id11dd78c3-3991-4a83-ad3e-2f2262d6bd6fspl_set_id2b25ef01-5c9e-11e1-b86c-0800200c9a66Package NDC 59572-501-21, 59572-501-00, 59572-502-21, 59572-502-00, 59572-503-21, 59572-503- ... NUIN0000184014Established Pharmacologic ClassThalidomide Analog [EPC]UNIID2UX06XLB5

46)

drugcharacterization2medicinalproductLYRICAdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext300 MILLIGRAMdrugdosageformUNKNOWNdrugadministrationroute065

activesubstance

activesubstancenamePREGABALIN

openFDA Info on Medication

Application NumberNDA021446, NDA022488Brand NameLYRICAGeneric NamePREGABALINManufacturersParke-Davis Div of Pfizer Inc, U.S. Pharmaceuticalsproduct_ndc 0071-1012, 0071-1013, 0071-1014, 0071-1015, 0071-1016, 0071-1017, 0071-1019, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREGABALINRXCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127, 607018, 607020, ... spl_idb9b1285a-2cb3-4789-8b0e-8d5e1b253534, 0fbd5d1f-30cd-464d-a1d6-71e8057a9377spl_set_id60185c88-ecfd-46f9-adb9-b97c6b00a553, ce1a4b9d-3127-4416-8bf2-fee5899fc0baPackage NDC 0071-1012-68, 0071-1013-41, 0071-1013-68, 0071-1014-41, 0071-1014-68, 0071-1015- ... UNII55JG375S6M

47)

drugcharacterization2medicinalproductKYPROLISdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

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_id926b52de-e4fc-4827-8cf0-21910483b0e5spl_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

48)

drugcharacterization2medicinalproductVITAMIN D2drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2000 UNITSdrugdosageformUNKNOWNdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameERGOCALCIFEROL

openFDA Info on Medication

Application NumberANDA090455Brand NameVITAMIN DGeneric NameERGOCALCIFEROLManufacturersStrides Pharma Science Limitedproduct_ndc64380-737Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERGOCALCIFEROLRXCUI1367410spl_id08a99dff-5765-49b0-b289-4e854d3c6725spl_set_id2c4c0a36-12cf-444d-9d57-de983eef4d36Package NDC64380-737-06, 64380-737-25NUIM0007651, N0000175909Chemical StructureErgocalciferols [CS]Established Pharmacologic ClassProvitamin D2 Compound [EPC]UNIIVS041H42XC

49)

drugcharacterization2medicinalproductVITAMIN D2drugindicationVOMITING

activesubstance

activesubstancenameERGOCALCIFEROL

openFDA Info on Medication

Application NumberANDA090455Brand NameVITAMIN DGeneric NameERGOCALCIFEROLManufacturersStrides Pharma Science Limitedproduct_ndc64380-737Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERGOCALCIFEROLRXCUI1367410spl_id08a99dff-5765-49b0-b289-4e854d3c6725spl_set_id2c4c0a36-12cf-444d-9d57-de983eef4d36Package NDC64380-737-06, 64380-737-25NUIM0007651, N0000175909Chemical StructureErgocalciferols [CS]Established Pharmacologic ClassProvitamin D2 Compound [EPC]UNIIVS041H42XC

50)

drugcharacterization2medicinalproductTIMOLOL MALEATE.drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext0.25drugdosageformEYE DROPSdrugadministrationroute047

activesubstance

activesubstancenameTIMOLOL MALEATE

openFDA Info on Medication

Application Number NDA019463, ANDA204936, NDA020330, NDA021516, ANDA074261, ANDA074262, NDA020963, ... Brand Name TIMOPTIC IN OCUDOSE, TIMOLOL MALEATE, TIMOPTIC-XE, ISTALOL, TIMOLOL GFS, TIMOPTI ... Generic NameTIMOLOL MALEATE, TIMOLOLManufacturers Bausch Health US LLC, Apotex Corp, Bausch & Lomb Incorporated, Sandoz Inc, Ocean ... product_ndc 0187-1496, 0187-1498, 60505-1005, 24208-814, 24208-816, 24208-004, 61314-226, 61 ... Product TypeHUMAN PRESCRIPTION DRUGRouteOPHTHALMIC, ORALActive IngredientsTIMOLOL MALEATE, TIMOLOLRXCUI 1922876, 1922877, 1922894, 1922895, 1992299, 313407, 313408, 861420, 861422, 199 ... spl_id c8e75822-985a-47a4-a5b2-baee3c6a7e22, c6bed03c-a758-1ab5-5c36-f6b61b4c5f01, f0a5 ... spl_set_id c1293d51-b633-486c-8e13-fcf60063faeb, df10af59-3b72-ca33-fd89-d9fcd0d61e9b, a4d0 ... Package NDC 0187-1498-25, 0187-1496-05, 0187-1496-99, 60505-1005-1, 60505-1005-4, 24208-814- ... UNIIP8Y54F701R, 817W3C6175

summary

narrativeincludeclinicalCASE EVENT DATE: 2013

Report Duplicate

duplicatesourceCELGENEduplicatenumbUS-CELGENEUS-163-POMAL-13123396

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use