Adverse Event Report

Report

reporttype1receiptdateformat102companynumbSYM-2014-18707Version of Safety Report ID1receivedateformat102seriousnessother1duplicate1transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10050957Date Received28/03/2014transmissiondate02/10/2014serious1Date Last Updated28/03/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age66Unit of Onset AgeyearsWeight76.66SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionRoad traffic accident

2)

reactionmeddraversionpt17.0ReactionMalaise

3)

reactionmeddraversionpt17.0ReactionHypersensitivity

4)

reactionmeddraversionpt17.0ReactionCough

5)

reactionmeddraversionpt17.0ReactionEye pruritus

6)

reactionmeddraversionpt17.0ReactionThroat irritation

7)

reactionmeddraversionpt17.0ReactionRhinorrhoea

8)

reactionmeddraversionpt17.0ReactionSinusitis

Drug

1)

drugcharacterization1medicinalproductMEPHYTONdrugauthorizationnumb010104drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberNDA010104Brand NameMEPHYTONGeneric NamePHYTONADIONEManufacturersBausch Health US LLCproduct_ndc0187-1704Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPHYTONADIONERXCUI198102, 207839spl_id90c52861-852b-4a55-bfd7-be70a95882ccspl_set_id5be7bb0a-dddb-4cb4-bf89-a8fafb726c83Package NDC0187-1704-05NUIN0000175965, N0000175982, M0022806, N0000180191, N0000175966Physiologic/Pharmacodynamic EffectIncreased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE]Chemical StructureVitamin K [CS]Established Pharmacologic ClassVitamin K [EPC], Warfarin Reversal Agent [EPC]UNIIA034SE7857

2)

drugcharacterization1medicinalproductADVAIRdrugadministrationroute055drugindicationRESPIRATORY DISORDER

openFDA Info on Medication

Application NumberNDA021077Brand NameADVAIR DISKUSGeneric NameFLUTICASONE PROPIONATE AND SALMETEROLManufacturersGlaxoSmithKline LLCproduct_ndc0173-0695, 0173-0696, 0173-0697Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsSALMETEROL XINAFOATE, FLUTICASONE PROPIONATERXCUI 896161, 896165, 896184, 896185, 896186, 896190, 896209, 896212, 896218, 896222, ... spl_idc03442a4-17dc-4c49-ae07-3f8f7f26e0dfspl_set_id4eeb5f6a-593f-4a9e-9692-adefa2caf8fcPackage NDC 0173-0695-00, 0173-0695-04, 0173-0696-00, 0173-0696-04, 0173-0697-00, 0173-0697- ... UNIIO2GMZ0LF5W, 6EW8Q962A5

3)

drugcharacterization1medicinalproductFLONASEdrugadministrationroute045drugindicationRESPIRATORY DISORDER

openFDA Info on Medication

Application NumberNDA205434Brand NameFLONASE ALLERGY RELIEFGeneric NameFLUTICASONE PROPIONATEManufacturersGlaxoSmithKline Consumer Healthcare Holdings (US) LLCproduct_ndc0135-0576Product TypeHUMAN OTC DRUGRouteNASALActive IngredientsFLUTICASONE PROPIONATERXCUI1797907, 1797933spl_id746e63f3-5386-4e7b-811d-8cfd3e9120d8spl_set_idb6134ba0-b70a-4eac-9a82-cef64b242c1dPackage NDC 0135-0576-01, 0135-0576-02, 0135-0576-03, 0135-0576-04, 0135-0576-12, 0135-0576- ... UNIIO2GMZ0LF5W

4)

drugcharacterization1medicinalproductRYTHMOLdrugstructuredosagenumb675drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationRESPIRATORY DISORDER

openFDA Info on Medication

Application NumberNDA021416Brand NameRYTHMOL SRGeneric NamePROPAFENONE HYDROCHLORIDEManufacturersGlaxoSmithKline LLCproduct_ndc0173-0823, 0173-0824, 0173-0826Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPROPAFENONE HYDROCHLORIDERXCUI861156, 861159, 861164, 861167, 861171, 861173spl_id274726a2-4a2f-4c49-b702-16d0d9147273spl_set_id8bb1bc4a-a019-49c8-af81-be899822428fPackage NDC0173-0823-18, 0173-0824-18, 0173-0826-18UNII33XCH0HOCD

5)

drugcharacterization1medicinalproductIPRATROPIUM BROMIDEdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application Number ANDA075562, ANDA075693, NDA021527, ANDA076103, ANDA076155, ANDA207903, ANDA07602 ... Brand NameIPRATROPIUM BROMIDE, ATROVENT HFAGeneric NameIPRATROPIUM BROMIDEManufacturers Nephron Pharmaceuticals Corporation, American Health Packaging, Boehringer Ingel ... product_ndc 0487-9801, 60687-394, 0597-0087, 24208-399, 60505-0827, 47335-706, 24208-398, 00 ... Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION), NASALActive IngredientsIPRATROPIUM BROMIDERXCUI836358, 836343, 836368, 1797844, 1797833spl_id b8a6d890-6561-40e9-e053-2a95a90a0d61, 98e25efe-8759-cbc3-e053-2a95a90ac41a, 694c ... spl_set_id db8095db-d1fd-4099-9fb1-d1ad4e284976, 8927f392-4c88-4ac1-a934-c444ecf6b2c8, 170e ... Package NDC 0487-9801-25, 0487-9801-30, 0487-9801-60, 0487-9801-01, 0487-9801-02, 60687-394- ... UNIIJ697UZ2A9J

6)

drugcharacterization1medicinalproductMONTELUKAST SODIUMdrugindicationASTHMA

openFDA Info on Medication

Application Number ANDA204093, ANDA204604, ANDA205683, ANDA205695, ANDA090984, ANDA201515, ANDA2104 ... Brand NameMONTELUKAST SODIUM, SINGULAIRGeneric NameMONTELUKAST SODIUM, MONTELUKASTManufacturers Camber Pharmaceuticals, Inc., Amneal Pharmaceuticals LLC, Hangzhou Minsheng Binj ... product_ndc 31722-727, 31722-728, 65162-732, 60723-010, 70436-090, 70436-091, 13668-079, 136 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMONTELUKAST, MONTELUKAST SODIUMRXCUI242438, 311759, 200224, 351246, 153892, 153893, 261367, 404406spl_id 533559ec-7167-4b38-aa0e-a4e7b3da19fc, 21e6eac4-35e5-488a-8d38-626e9569b200, a622 ... spl_set_id 23964723-2df8-4d0a-a53d-8538469672f1, ccbbf0d6-efd9-4fdd-9e7b-e3d293062609, 7223 ... Package NDC 31722-727-30, 31722-727-01, 31722-727-10, 31722-727-31, 31722-727-32, 31722-727- ... NUIN0000175777, N0000000083Established Pharmacologic ClassLeukotriene Receptor Antagonist [EPC]Mechanism of ActionLeukotriene Receptor Antagonists [MoA]UNIIMHM278SD3E, U1O3J18SFL

7)

drugcharacterization1medicinalproductALLERGY MEDICATIONdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

8)

drugcharacterization2medicinalproductSODIUM RABEPRAZOLE (RABEPRAZOLE SODIUM0

9)

drugcharacterization2medicinalproductSALBUTAMOL SULPHATE

10)

drugcharacterization2medicinalproductSPIRONOLACTONE

openFDA Info on Medication

Application Number ANDA091426, ANDA040750, ANDA203512, ANDA203253, NDA012151, ANDA089424, ANDA20593 ... Brand NameSPIRONOLACTONE, ALDACTONEGeneric NameSPIRONOLACTONEManufacturers Amneal Pharmaceuticals LLC, Oxford Pharmaceuticals, LLC, Accord Healthcare, Inc. ... product_ndc 65162-511, 65162-514, 65162-515, 69584-852, 69584-853, 69584-854, 16729-225, 167 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSPIRONOLACTONERXCUI198222, 198223, 313096spl_id 5c663162-67fb-4890-977c-70db2561d387, db73b6cc-b152-4ec1-8566-f4ead6f9ae6d, 9590 ... spl_set_id fb66327e-8261-46ae-b39a-4fa79d520844, 852684dc-e1c6-4caa-bccb-10ac90bbb3bb, 8a96 ... Package NDC 65162-511-03, 65162-511-06, 65162-511-09, 65162-511-10, 65162-511-11, 65162-511- ... NUIN0000175557, N0000011310Established Pharmacologic ClassAldosterone Antagonist [EPC]Mechanism of ActionAldosterone Antagonists [MoA]UNII27O7W4T232

11)

drugcharacterization2medicinalproductDIPHENHYDRAMINE HCL (DIPHENHYDRAMINE HYDROCHLORIDE)

12)

drugcharacterization2medicinalproductDICYCLOMINE HYDROCHLORIDE (DICYCLOVERINE HYDROCHLORIDE)

13)

drugcharacterization2medicinalproductCITRACAL (CITRACAL + D /01438101/) (ERGOCALCIFEROL, CALCIUM CITRATE)

14)

drugcharacterization2medicinalproductWARFARIN SODIUM

openFDA Info on Medication

Application NumberANDA040663, ANDA040301, ANDA090935, ANDA040416, ANDA040616, ANDA202202Brand NameWARFARIN SODIUM, JANTOVENGeneric NameWARFARIN SODIUM, WARFARINManufacturers Cadila Healthcare Limited, Taro Pharmaceuticals U.S.A., Inc., Exelan Pharmaceuti ... product_ndc 65841-052, 65841-053, 65841-064, 65841-054, 65841-055, 65841-056, 65841-057, 658 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsWARFARIN SODIUMRXCUI 855288, 855296, 855302, 855312, 855318, 855324, 855332, 855338, 855344, 855292, ... spl_id b9846c53-80c7-4264-a78f-87c3b18edfc7, 23995412-b23d-4ea0-96df-f1b31ce4f024, 45e8 ... spl_set_id 3fb2aa58-3a40-4255-a261-e2db5b9a5dde, 8ad881e0-ca41-42ad-9d7d-eb85b3a30af0, c0cc ... Package NDC 65841-052-01, 65841-052-10, 65841-053-01, 65841-053-10, 65841-064-01, 65841-064- ... UNII6153CWM0CL

15)

drugcharacterization2medicinalproductPANCREATIN

openFDA Info on Medication

Brand NamePANCREATINUMGeneric NamePANCREATINManufacturersSeroyal USAproduct_ndc62106-7110Product TypeHUMAN OTC DRUGRouteORALActive IngredientsORYCTOLAGUS CUNICULUS WHOLEspl_id9a75318e-26fd-781a-e053-2a95a90a44f6spl_set_id155903b0-3998-24c4-e054-00144ff8d46cPackage NDC62106-7110-4UNII768BE616L8

16)

drugcharacterization2medicinalproductDIAZEPAM

openFDA Info on Medication

Application Number ANDA072079, ANDA071134, ANDA071135, ANDA071136, NDA020124, ANDA210363, NDA020648 ... Brand NameDIAZEPAM, DIASTAT, VALTOCO, VALIUMGeneric NameDIAZEPAMManufacturers Hospira, Inc., Mayne Pharma, Meridian Medical Technologies, Inc., Dash Pharmaceu ... product_ndc 0409-1273, 51862-062, 51862-063, 51862-064, 11704-600, 69339-136, 66490-650, 686 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORAL, RECTAL, NASALActive IngredientsDIAZEPAMspl_id 14233fc1-606a-4e78-8da4-df9eedb1c793, 49cd2631-74e5-4291-a491-b15b2fa31ee3, 26b3 ... spl_set_id 41044928-dd1f-40bf-1fa6-709dff559124, 7d81850c-ad3f-4e2e-ac41-ed9c567aea4b, fa35 ... Package NDC 0409-1273-03, 0409-1273-32, 51862-062-01, 51862-062-05, 51862-062-10, 51862-063- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIQ3JTX2Q7TURXCUI197589, 197590, 197591, 2120550, 801957, 801961, 801966, 309843, 309844, 309845

17)

drugcharacterization2medicinalproductASCORBIC ACID

openFDA Info on Medication

Brand NameASCORBIC ACID, DR CELLAPY SR PREMIUM, ASCOR, AROMACURA SHOWER FILTERGeneric NameASCORBIC ACIDManufacturers Mylan Institutional LLC, Deseret Biologicals, Inc., GM Holdings Co., Ltd, McGuff ... product_ndc67457-118, 43742-0561, 69278-100, 67157-101, 72832-0010Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, ORAL, TOPICALActive IngredientsASCORBIC ACIDRXCUI308395, 2002739spl_id 55bc23e3-828d-4b2f-8fd7-30c785555140, b11b2d5b-fc71-4d20-acaa-36a10dafc6aa, 9ca0 ... spl_set_id d05200cb-cf29-4bc7-bf0c-b42ab2d20958, 2921d70b-834f-4eb9-abc3-6e9438c3167f, 1082 ... Package NDC 67457-118-50, 43742-0561-1, 69278-100-02, 69278-101-01, 69278-101-02, 69278-102- ... NUIN0000193618, M0001797Established Pharmacologic ClassVitamin C [EPC]Chemical StructureAscorbic Acid [CS]UNIIPQ6CK8PD0RApplication NumberNDA209112

18)

drugcharacterization2medicinalproductVITAMIN E (TOCOPHEROL)

19)

drugcharacterization2medicinalproductFIORICET WITH CODEINE (CODEINE PHOSPHATE, CAFFEINE, BUTALBITAL, PARACETAMOL)

20)

drugcharacterization2medicinalproductFOLIC ACID

openFDA Info on Medication

Application Number ANDA040796, ANDA204418, ANDA202437, ANDA091145, ANDA211064, ANDA202522, ANDA0407 ... Brand NameFOLIC ACID, VENEXA, VITREXYL, VITREXATE, VITRANOLGeneric NameFOLIC ACIDManufacturers Leading Pharma, LLC, Marlex Pharmaceuticals Inc, PureTek Corporation, Cadila Pha ... product_ndc 69315-127, 10135-182, 59088-176, 71209-007, 58657-150, 11534-165, 58657-151, 731 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSActive Ingredients FOLIC ACID, .ALPHA.-TOCOPHEROL ACETATE, DL-, MAGNESIUM OXIDE, CHROMIUM NICOTINAT ... RXCUI310410, 237786spl_id 92322e52-3179-4738-8c8a-14fef62311d4, ba726c8a-bfad-11f7-e053-2995a90a239e, ba13 ... spl_set_id 1ba8c407-9613-4319-ac40-0a429cb0f3f4, 35cd5498-0af8-4bcc-a755-bf30f37b091a, ba13 ... Package NDC 69315-127-01, 69315-127-10, 10135-182-01, 10135-182-10, 59088-176-54, 71209-007- ... UNII 935E97BOY8, WR1WPI7EW8, 3A3U0GI71G, A150AY412V, 68Y4CF58BV, 81AH48963U, H6241UJ2 ... NUIM0022797, N0000175952, N0000193618, M0001797, M0022794, N0000175951Chemical StructureVitamin D [CS], Ascorbic Acid [CS], Vitamin B 12 [CS]Established Pharmacologic ClassVitamin D [EPC], Vitamin C [EPC], Vitamin B12 [EPC]

21)

drugcharacterization2medicinalproductFRUSEMIDE (FUROSEMIDE)

22)

drugcharacterization2medicinalproductGUAIPHENESIN (GUAIPHENESIN EXTENDED RELEASE)

23)

drugcharacterization2medicinalproductNORCO (VICODIN) (PARACETAMOL, HYDROCODONE BITARTRATE)

24)

drugcharacterization2medicinalproductPOTASSIUM CHLORIDE

openFDA Info on Medication

Brand Name KALI MURIATICUM, POTASSIUM CHLORIDE, SORE THROAT 911, KLOR-CON M, POTASSIUM CHLO ... Generic NamePOTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASEManufacturers 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 CATIONspl_id 603fa445-ab7d-3929-e053-2a91aa0afb47, 4dca93f2-d9a9-4ecb-89d2-f67b819f82dc, ebba ... 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, 31722-133-10, 31722-134- ... UNII660YQ98I10, 295O53K152Application 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]

25)

drugcharacterization2medicinalproductPRAVASTATIN SODIUM

openFDA Info on Medication

Application Number ANDA209869, ANDA207068, ANDA076056, ANDA077793, ANDA076714, ANDA077917, ANDA2033 ... Brand NamePRAVASTATIN SODIUM, PRAVACHOLGeneric NamePRAVASTATIN SODIUMManufacturers BIOCON PHARMA INC.,, Accord Healthcare Inc., Teva Pharmaceuticals USA, Inc., Dr. ... product_ndc 70377-045, 70377-046, 70377-047, 70377-048, 16729-008, 16729-009, 16729-010, 167 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPRAVASTATIN SODIUMRXCUI904458, 904467, 904475, 904481, 904469, 904477spl_id 35751ea8-7d0f-5334-0e36-df438b2b9202, 96d49c2d-3263-3692-e053-2995a90ac8f4, c288 ... spl_set_id 9bd4a493-1f75-e33a-53fb-4e2fbc64a1eb, 6c011348-a236-47d3-bbef-3e0b956dd080, 99e0 ... Package NDC 70377-045-11, 70377-045-12, 70377-045-14, 70377-046-11, 70377-046-12, 70377-046- ... UNII3M8608UQ61

26)

drugcharacterization2medicinalproductBECLOMETHASONE DIPROPIONATE

openFDA Info on Medication

Application NumberNDA202813Brand NameQNASLGeneric NameBECLOMETHASONE DIPROPIONATEManufacturersTeva Respiratory, LLCproduct_ndc59310-406, 59310-410Product TypeHUMAN PRESCRIPTION DRUGRouteNASALActive IngredientsBECLOMETHASONE DIPROPIONATERXCUI1797900, 1797902, 1797920, 1797921spl_id51e488e5-60e2-4cfb-97a3-e34a0d74770espl_set_id4b8d8e84-b5d2-4e56-97ec-4f72971465c5Package NDC59310-406-06, 59310-406-08, 59310-410-12, 59310-410-13UNII5B307S63B2

27)

drugcharacterization2medicinalproductZOLEDRONIC ACID

openFDA Info on Medication

Application Number ANDA204217, ANDA091186, NDA204016, ANDA091170, ANDA207751, ANDA202650, NDA021817 ... Brand NameZOLEDRONIC ACID, RECLASTGeneric NameZOLEDRONIC ACIDManufacturers Fresenius Kabi USA, LLC, Dr. Reddy's Laboratories Limited, Hospira, Inc., Dr. Re ... product_ndc 63323-966, 55111-685, 0409-4229, 43598-330, 51991-065, 55150-266, 67457-390, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsZOLEDRONIC ACIDRXCUI705824, 351114, 1114085, 705875spl_id 7e97e142-a680-f566-e053-2991aa0aadeb, cb61b922-aa73-27ed-a2d9-dfe6e8a005f9, c74a ... spl_set_id 16fcf8c9-ef8a-4e93-9ee6-acfadd35a861, 1738a682-5903-b675-3a7a-61d299a6f248, e446 ... Package NDC 63323-966-00, 55111-685-07, 0409-4229-01, 43598-330-11, 51991-065-98, 55150-266- ... UNII6XC1PAD3KF

28)

drugcharacterization2medicinalproductSIMETHICONE

openFDA Info on Medication

Application Numberpart332, part347, part331, part356Brand Name ULTRA STRENGTH GAS RELIEF, GAS RELIEF ULTRA STRENGTH, SIMETHICONE, GAS RELIEF EX ... Generic NameSIMETHICONEManufacturers Chain Drug Marketing Association Inc., TOP CARE (Topco Associates LLC), Spirit P ... product_ndc 63868-098, 36800-963, 68210-0314, 41163-608, 11788-032, 41250-882, 21130-015, 59 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsDIMETHICONE, CALCIUM CARBONATE, SILICON DIOXIDERXCUI 252294, 314221, 198857, 198852, 412111, 809376, 314216, 2262288, 2119393, 603288 ... spl_id 825a9598-82c0-40d9-85ec-689708dbd7c8, 679bebfe-4b3c-48af-aeac-c9e65c8d947f, a0fc ... spl_set_id 01911ad2-063d-4d8c-b6ea-09784b883548, 3be41f57-862b-472c-97a7-91d0a0a3074b, 6844 ... Package NDC 63868-098-60, 36800-963-50, 68210-0314-5, 41163-608-44, 11788-032-00, 41250-882- ... NUIN0000010282Physiologic/Pharmacodynamic EffectSkin Barrier Activity [PE]UNII92RU3N3Y1O, H0G9379FGK, ETJ7Z6XBU4

29)

drugcharacterization2medicinalproductIRON SALT (IRON)

30)

drugcharacterization2medicinalproductTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)

31)

drugcharacterization2medicinalproductMETOPROLOL SUCCINATE

openFDA Info on Medication

Application Number ANDA090617, ANDA203028, ANDA203894, ANDA203699, ANDA076862, ANDA077298, NDA01996 ... Brand NameMETOPROLOL SUCCINATE, TOPROL XL, KAPSPARGOGeneric NameMETOPROLOL SUCCINATE, METOPROLOL SUCCINATE ER TABLETSManufacturers BluePoint Laboratories, Pharmadax Inc., Zydus Pharmaceuticals (USA) Inc., Actavi ... product_ndc 68001-121, 68001-122, 60050-001, 60050-002, 68382-564, 68382-565, 68382-566, 683 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETOPROLOL SUCCINATE, METOPROLOL TARTRATERXCUI 866427, 866436, 866412, 866419, 866414, 866421, 866429, 866438, 1999031, 1999033 ... spl_id 98f8056c-5885-e243-e053-2995a90a68d1, a2d8f185-a2c4-bc6f-e053-2995a90aeea9, b573 ... spl_set_id 7bacd1ea-5546-47a1-8cff-a30327cadec3, b292330e-c69c-4915-a984-e3a62a327796, bd77 ... Package NDC 68001-121-00, 68001-121-03, 68001-122-00, 68001-122-03, 60050-001-01, 60050-001- ... UNIITH25PD4CCB, W5S57Y3A5L

32)

drugcharacterization2medicinalproductTYLENOL WITH COEDINE (PANADEINE CO) (CODEINE PHOSPHATE, PARACETAMOL)

33)

drugcharacterization2medicinalproductVALACICOLVIR HYDROCHLORIDE

34)

drugcharacterization2medicinalproductVANCOMYCIN

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]

35)

drugcharacterization2medicinalproductCYANOCOBALAMIN

openFDA Info on Medication

Application Number ANDA206503, ANDA213874, ANDA209255, ANDA080515, NDA021642, ANDA080737, ANDA20942 ... Brand Name CYANOCOBALAMIN, VITAMIN DEFICIENCY SYSTEM, COCO12, NASCOBAL, VITAMIN DEFICIENCY ... Generic NameCYANOCOBALAMINManufacturers Somerset Therapeutics, LLC, AuroMedics Pharma LLC, Vitruvias Therapeutics, West- ... product_ndc 70069-005, 70069-172, 55150-364, 69680-112, 69680-113, 69680-121, 0143-9619, 014 ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteINTRAMUSCULAR, SUBCUTANEOUS, TOPICAL, NASALActive IngredientsCYANOCOBALAMINRXCUI309594, 861113, 861115, 797544spl_id f24e1ba1-2063-44bf-958e-d3fad248436d, db84d0ea-5c15-47f5-bbe2-8d455e75695e, 47ad ... spl_set_id 41ac0dc1-0a71-4c69-8e25-ba838f5f16a3, db84d0ea-5c15-47f5-bbe2-8d455e75695e, 2117 ... Package NDC 70069-005-01, 70069-005-10, 70069-172-01, 70069-172-10, 70069-172-25, 55150-364- ... NUIM0022794, N0000175951Chemical StructureVitamin B 12 [CS]Established Pharmacologic ClassVitamin B12 [EPC]UNIIP6YC3EG204

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drugcharacterization2medicinalproductMULTIVITAMINS + MINERALS (MINERALS NOS W/VITAMINS NOS)

37)

drugcharacterization2medicinalproductONDANSETRON HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA076183, ANDA078539, ANDA078776, ANDA090116, ANDA077729, NDA020103, ANDA07697 ... Brand NameONDANSETRON HYDROCHLORIDE, ONDANSETRON, ZOFRANGeneric NameONDANSETRON HYDROCHLORIDE, ONDANSETRONManufacturers Dr. Reddy's Laboratories Limited, Aurobindo Pharma Limited, NorthStar Rx LLC, La ... product_ndc 55111-153, 55111-154, 55111-156, 65862-187, 65862-188, 65862-189, 16714-671, 052 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsONDANSETRON HYDROCHLORIDERXCUI 198052, 312084, 312086, 312085, 283504, 1740467, 104895, 104896, 692695, 1314133 ... spl_id 7112c99c-2cce-1faa-5d82-45b0fd973bb0, 6e42aef7-5459-4ee3-9e3a-7d6d6d8a9b1c, f821 ... spl_set_id 162f2088-9fb1-47e7-b88c-45104be7e7bb, 57578387-1918-4e56-a564-f14fb22340bf, ac3d ... Package NDC 55111-153-30, 55111-153-01, 55111-153-05, 55111-153-78, 55111-153-13, 55111-154- ... UNIINMH84OZK2B, 4AF302ESOSNUIN0000175817, N0000175818Mechanism of ActionSerotonin 3 Receptor Antagonists [MoA]Established Pharmacologic ClassSerotonin-3 Receptor Antagonist [EPC]

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drugcharacterization2medicinalproductSERTRALINE HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA077206, NDA020990, NDA019839, ANDA078861, ANDA077864, ANDA077106, ANDA076934 ... Brand NameSERTRALINE HYDROCHLORIDE, SERTRALINE, ZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturers Aurobindo Pharma Limited, Greenstone LLC, Rising Pharmaceuticals, Inc., Hikma Ph ... product_ndc 65862-011, 65862-012, 65862-013, 59762-0067, 59762-4960, 59762-4900, 59762-4910, ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941, 861064, 208149, 208161, 212233, 861066spl_id 80aac5d8-bb02-46f5-a8ca-5fc9f934541c, 1ef7897d-60bb-4685-820f-21c78a097642, 96aa ... spl_set_id 39a85db1-9e59-4ab0-9e18-36757f019faa, 1a58062b-e635-431a-908d-2651c6a4a21c, af2c ... Package NDC 65862-011-30, 65862-011-50, 65862-011-60, 65862-011-90, 65862-011-01, 65862-011- ... UNIIUTI8907Y6X

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drugcharacterization2medicinalproductPNEUMOCOCCAL VAC NONGSK

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drugcharacterization2medicinalproductSEASON TRIVAL INFLU DRESD (OTHER THERAPEUTIC PRODUCTS)

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drugcharacterization2medicinalproductNORMAL IMMUNOGLOBULIN

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