Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10062780serious1Date Last Updated19/05/2014seriousnesslifethreatening1receiptdateformat102companynumbUS-BAYER-2014-050823occurcountryUSduplicate1Date Received07/04/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryUSseriousnessdisabling1

Primary Source

reportercountryUSqualification5

Patient

Onset Age36Unit of Onset AgeyearsWeight77.1SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionPulmonary embolism

2)

reactionmeddraversionpt17.0ReactionDyspnoea

3)

reactionmeddraversionpt17.0ReactionFatigue

4)

reactionmeddraversionpt17.0ReactionOxygen saturation decreased

5)

reactionmeddraversionpt17.0ReactionInjury

6)

reactionmeddraversionpt17.0ReactionPain

7)

reactionmeddraversionpt17.0ReactionGeneral physical health deterioration

8)

reactionmeddraversionpt17.0ReactionAnxiety

9)

reactionmeddraversionpt17.0ReactionEmotional distress

10)

reactionmeddraversionpt17.0ReactionPain

11)

reactionmeddraversionpt17.0ReactionDeformity

Drug

1)

drugcharacterization1medicinalproductYASMINdrugauthorizationnumb021098drugdosagetextUNKdrugdosageformFILM-COATED TABLETdrugstartdateformat102drugstartdate30/04/2004drugenddateformat102drugenddate13/05/2011actiondrug1

openFDA Info on Medication

Application NumberNDA021098Brand NameYASMINGeneric NameDROSPIRENONE AND ETHINYL ESTRADIOLManufacturersBayer HealthCare Pharmaceuticals Inc.product_ndc50419-402Product TypeHUMAN PRESCRIPTION DRUGRXCUI284207, 748797, 748800, 748857spl_id0972cd1d-53a1-465e-b09c-5be40ef658cbspl_set_idd7ea6a60-5a56-4f81-b206-9b27b7e58875Package NDC50419-402-03

2)

drugcharacterization1medicinalproductYAZdrugdosagetextUNKdrugdosageformFILM-COATED TABLETdrugstartdateformat102drugstartdate30/04/2004drugenddateformat102drugenddate13/05/2011actiondrug1

openFDA Info on Medication

Application NumberNDA021676Brand NameYAZGeneric NameDROSPIRENONE AND ETHINYL ESTRADIOLManufacturersBayer HealthCare Pharmaceuticals Inc.product_ndc50419-405Product TypeHUMAN PRESCRIPTION DRUGRXCUI630734, 748797, 748798, 748856spl_idc138e16e-20a7-4893-9ff0-29f930446b38spl_set_id065f33e4-b587-4e66-b896-ca9ab7b7c876Package NDC50419-405-03

3)

drugcharacterization2medicinalproductASCORBIC ACIDdrugstructuredosagenumb1000drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb42000drugcumulativedosageunit003drugdosagetext1000 MG, BIDdrugindicationSICKLE CELL ANAEMIAdrugstartdateformat102drugstartdate19/04/2011drugenddateformat102drugenddate09/05/2011

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

4)

drugcharacterization2medicinalproductFOLIC ACIDdrugdosagetextUNKdrugindicationSICKLE CELL ANAEMIAdrugstartdateformat602drugstartdate//1980

openFDA Info on Medication

Application Number ANDA040796, ANDA204418, ANDA202437, ANDA091145, ANDA211064, ANDA202522, ANDA0407 ... Brand NameFOLIC ACID, VENEXA, VITREXYL, 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]

5)

drugcharacterization2medicinalproductSERTRALINEdrugdosagetextUNKdrugstartdateformat602drugstartdate//2004

openFDA Info on Medication

Application NumberANDA077670, ANDA077864, ANDA077397Brand NameSERTRALINEGeneric NameSERTRALINE, SERTRALINE HYDROCHLORIDEManufacturers Lupin Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Exelan Pharmaceutic ... product_ndc 68180-351, 68180-352, 68180-353, 0143-9655, 0143-9656, 0143-9654, 76282-212, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941spl_id 78d3579a-260f-4bb2-95f2-8ee8a60fae18, f35de481-61af-428e-abb4-a267238b3959, 5c8d ... spl_set_id 42120ff8-b353-4632-9ea9-54de9a698724, f9641190-9151-4f7e-89ff-1e7a818c30ee, 2dac ... Package NDC 68180-351-06, 68180-351-08, 68180-351-09, 68180-351-01, 68180-351-03, 68180-352- ... UNIIUTI8907Y6X

6)

drugcharacterization2medicinalproductABILIFYdrugstructuredosagenumb5drugstructuredosageunit003drugdosagetext5 MG, DAILYdrugindicationDEPRESSIONdrugstartdateformat102drugstartdate19/04/2011drugenddateformat102drugenddate09/05/2011

openFDA Info on Medication

Application NumberNDA021436Brand NameABILIFYGeneric NameARIPIPRAZOLEManufacturersOtsuka America Pharmaceutical, Inc.product_ndc 59148-006, 59148-007, 59148-008, 59148-009, 59148-010, 59148-011, 59148-013, 591 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsARIPIPRAZOLERXCUI 349490, 349545, 349547, 349553, 352307, 352308, 352309, 352310, 402131, 404602, ... spl_id85ae6d7d-eb0f-44b1-bb1f-b58d196124a4spl_set_idc040bd1d-45b7-49f2-93ea-aed7220b30acPackage NDC 59148-006-13, 59148-006-92, 59148-007-13, 59148-007-35, 59148-007-94, 59148-008- ... NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNII82VFR53I78

7)

drugcharacterization2medicinalproductAMBIENdrugdosagetextUNKdrugindicationINSOMNIAdrugstartdateformat102drugstartdate19/04/2011drugenddateformat102drugenddate09/05/2011

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

8)

drugcharacterization2medicinalproductCELEBREXdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb4200drugcumulativedosageunit003drugdosagetext100 MG, BIDdrugindicationARTHRITISdrugstartdateformat102drugstartdate19/04/2011drugenddateformat102drugenddate09/05/2011

openFDA Info on Medication

Application NumberNDA020998Brand NameCELEBREXGeneric NameCELECOXIBManufacturersG.D. Searle LLC Division of Pfizer Incproduct_ndc0025-1515, 0025-1520, 0025-1525, 0025-1530Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCELECOXIBRXCUI205322, 205323, 213468, 213469, 349514, 352314, 686379, 686381spl_idd2a1146b-f1a6-4467-9ba8-b10f94494f8espl_set_id8d52185d-421f-4e34-8db7-f7676db2a226Package NDC 0025-1515-01, 0025-1520-31, 0025-1520-51, 0025-1520-34, 0025-1525-31, 0025-1525- ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIJCX84Q7J1L

9)

drugcharacterization2medicinalproductCLARITINdrugdosagetextUNKdrugindicationMULTIPLE ALLERGIESdrugstartdateformat602drugstartdate//2010

openFDA Info on Medication

Application NumberNDA020704, NDA019658, NDA021952, NDA021891, NDA021993Brand NameCLARITIN REDITABS, CLARITIN, CLARITIN LIQUI-GELSGeneric NameLORATADINEManufacturersBayer Healthcare LLC., Bayer HealthCare LLC., Bayer HealthCare LLCproduct_ndc 11523-4329, 11523-7157, 11523-0007, 11523-6655, 11523-1527, 11523-7237, 11523-71 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsLORATADINERXCUI311373, 744830, 206805, 311372, 828269, 836338, 665078, 668469, 672558, 904026spl_id 9999c20a-a166-64be-e053-2995a90ad2ce, bb8f183a-a014-b076-e053-2995a90a1d1e, 55ed ... spl_set_id b681ea25-d00b-4c8a-8054-cc6f983ce337, acf2d393-53d7-062f-e053-2995a90a0d60, ac32 ... Package NDC 11523-7157-2, 11523-7157-3, 11523-7157-4, 11523-7157-7, 11523-7157-8, 11523-7157 ... UNII7AJO3BO7QN

10)

drugcharacterization2medicinalproductDILAUDIDdrugdosagetextUNKdrugindicationSICKLE CELL ANAEMIAdrugstartdateformat102drugstartdate19/04/2011drugenddateformat102drugenddate09/05/2011

openFDA Info on Medication

Application NumberNDA019034, NDA019892, NDA019891Brand NameDILAUDIDGeneric NameHYDROMORPHONE HYDROCHLORIDEManufacturersFresenius Kabi USA, LLC, Rhodes Pharmaceuticals L.P.product_ndc76045-009, 76045-010, 76045-121, 42858-122, 42858-234, 42858-338, 42858-416Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, ORALActive IngredientsHYDROMORPHONE HYDROCHLORIDERXCUI 897756, 897757, 1433251, 1872265, 1872269, 1872752, 2277368, 2277370, 897657, 89 ... spl_id 91e4f1a1-03b1-4625-b4d4-19ab7667ee4c, f89754d5-a3d4-44c9-b175-1bf0581e18da, 487e ... spl_set_id 9eebd88a-5632-460f-b7b6-26c8a180540d, 4d77772f-874f-9c87-2d80-ca467c7690a1, d6b4 ... Package NDC 76045-009-96, 76045-009-06, 76045-009-01, 76045-009-11, 76045-010-01, 76045-010- ... UNIIL960UP2KRW

11)

drugcharacterization2medicinalproductELAVILdrugdosagetextUNKdrugindicationINSOMNIAdrugstartdateformat602drugstartdate//2010drugenddateformat602drugenddate//2011

12)

drugcharacterization2medicinalproductELAVILdrugdosagetext50-100 MG DAILYdrugindicationDEPRESSIONdrugstartdateformat102drugstartdate19/04/2011drugenddateformat102drugenddate09/05/2011

13)

drugcharacterization2medicinalproductFLEXERILdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb420drugcumulativedosageunit003drugdosagetext10 MG, BIDdrugindicationMUSCLE SPASMSdrugstartdateformat102drugstartdate19/04/2011drugenddateformat102drugenddate09/05/2011

openFDA Info on Medication

14)

drugcharacterization2medicinalproductATARAXdrugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MG,DAILYdrugindicationOSTEOPENIAdrugstartdateformat102drugstartdate19/04/2011drugenddateformat102drugenddate09/05/2011

15)

drugcharacterization2medicinalproductCOLACEdrugdosagetext100-300 MG DAILYdrugindicationCONSTIPATIONdrugstartdateformat102drugstartdate19/04/2011drugenddateformat102drugenddate09/05/2011

openFDA Info on Medication

Application Numberpart334Brand NameCOLACEGeneric NameDOCUSATE SODIUM, DOCUSATE SODIUM - SENNOSIDESManufacturersAvrio Health L.P.product_ndc67618-101, 67618-110, 67618-111Product TypeHUMAN OTC DRUGRouteORALActive IngredientsDOCUSATE SODIUM, SENNOSIDESRXCUI1115005, 1247756, 998740, 1872920, 1247759, 1247761spl_id 008f0cb3-8a9a-42f6-b985-a3dbc0deabc0, 7ec009a7-4793-524b-5e6d-202f324d81fd, f8b2 ... spl_set_id 7793fced-e8ee-44e2-b212-dd2a59a5f462, 9fce5c4b-1e2e-47ef-13e5-c3bd5320d41b, a159 ... Package NDC 67618-101-10, 67618-101-30, 67618-101-60, 67618-101-52, 67618-110-10, 67618-110- ... UNIIF05Q2T2JA0, 3FYP5M0IJX

16)

drugcharacterization2medicinalproductVITAMIN EdrugdosagetextUNKdrugstartdateformat102drugstartdate19/04/2011drugenddateformat102drugenddate09/05/2011

17)

drugcharacterization2medicinalproductSUDAFEDdrugstructuredosagenumb60drugstructuredosageunit003drugdosagetext60 MG, UNKdrugindicationNASAL CONGESTIONdrugstartdateformat102drugstartdate19/04/2011drugenddateformat102drugenddate09/05/2011

openFDA Info on Medication

Application NumberNDA020021, part341Brand NameSUDAFED 24 HOUR, SUDAFEDGeneric NamePSEUDOEPHEDRINE HYDROCHLORIDEManufacturersJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Divisionproduct_ndc50580-669, 50580-545Product TypeHUMAN OTC DRUGRouteORALActive IngredientsPSEUDOEPHEDRINE HYDROCHLORIDERXCUI1049670, 1049672, 1049160, 1049529spl_id6a06fbd9-c10d-43a4-9a6e-be1720992624, 0243c7ca-77fa-4189-bce2-ada15361b6cbspl_set_id9991599a-b49b-4ea6-a6e1-c05f0c992f71, d280abe9-6bdf-4e1e-a0cf-95fd0451c999Package NDC50580-669-10, 50580-545-24, 50580-545-72, 50580-545-48UNII6V9V2RYJ8N

18)

drugcharacterization2medicinalproductFLONASEdrugdosagetextUNKdrugindicationMULTIPLE ALLERGIESdrugstartdateformat602drugstartdate//2011

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

19)

drugcharacterization2medicinalproductCITRACALdrugdosagetextUNK

20)

drugcharacterization2medicinalproductDULCOLAX [BISACODYL]drugdosagetext5-15 MG DAILYdrugindicationCONSTIPATIONdrugstartdateformat102drugstartdate19/04/2011drugenddateformat102drugenddate09/05/2011

21)

drugcharacterization2medicinalproductLEVAQUINdrugdosagetextUNKdrugstartdateformat102drugstartdate09/05/2011

openFDA Info on Medication

22)

drugcharacterization2medicinalproductALBUTEROLdrugdosagetextUNKdrugstartdateformat102drugstartdate09/05/2011

openFDA Info on Medication

Application Number ANDA210948, ANDA077788, ANDA213657, ANDA211397, ANDA208804, ANDA207046, ANDA0728 ... Brand NameALBUTEROL, ALBUTEROL SULFATEGeneric NameALBUTEROL SULFATE, ALBUTEROLManufacturers Nivagen Pharmaceuticals Inc, VistaPharm, Inc., Aurobindo Pharma Limited, Virtus ... product_ndc 75834-273, 75834-274, 66689-100, 59651-333, 59651-334, 69543-290, 69543-291, 692 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALBUTEROL SULFATERXCUI197316, 197318, 755497spl_id b736135f-6e13-3e29-e053-2a95a90a67f4, 737932ca-a391-48c3-96c5-14de8ae1000e, ff9b ... spl_set_id b735e92d-eb1a-6fc1-e053-2995a90afce2, c7713a63-af2a-40d3-8deb-cbb92d5f1cd3, ff9b ... Package NDC 75834-273-01, 75834-274-01, 66689-100-16, 66689-100-08, 59651-333-01, 59651-333- ... UNII021SEF3731

23)

drugcharacterization2medicinalproductPROTONIXdrugstructuredosagenumb40drugstructuredosageunit003drugdosagetext40 MG, DAILYdrugindicationGASTROOESOPHAGEAL REFLUX DISEASEdrugstartdateformat102drugstartdate19/04/2011drugenddateformat102drugenddate09/05/2011

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

24)

drugcharacterization2medicinalproductPRISTIQdrugdosagetextUNKdrugindicationDEPRESSIONdrugstartdateformat102drugstartdate19/04/2011drugenddateformat102drugenddate09/05/2011

openFDA Info on Medication

Application NumberNDA021992Brand NamePRISTIQ EXTENDED-RELEASEGeneric NameDESVENLAFAXINE SUCCINATEManufacturersWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.product_ndc0008-1210, 0008-1211, 0008-1222Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDESVENLAFAXINE SUCCINATERXCUI790267, 790290, 1607617, 1607619, 1874553, 1874559spl_idafb3acb3-3c1c-42a0-98b7-9f3ea41450fbspl_set_id0f43610c-f290-46ea-d186-4f998ed99fcePackage NDC 0008-1211-50, 0008-1211-01, 0008-1211-14, 0008-1211-30, 0008-1222-01, 0008-1222- ... UNIIZB22ENF0XR

25)

drugcharacterization2medicinalproductNEURONTINdrugstructuredosagenumb60drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb3780drugcumulativedosageunit003drugdosagetext60 MG, TIDdrugindicationNEURALGIAdrugstartdateformat102drugstartdate19/04/2011drugenddateformat102drugenddate09/05/2011

openFDA Info on Medication

Application NumberNDA020882, NDA020235, NDA021129Brand NameNEURONTINGeneric NameGABAPENTINManufacturersParke-Davis Div of Pfizer Incproduct_ndc0071-0401, 0071-0803, 0071-0805, 0071-0806, 0071-0513, 0071-2012Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGABAPENTINRXCUI 105028, 105029, 105030, 261280, 261281, 283523, 310430, 310431, 310432, 310433, ... spl_id597965f8-e2d2-4010-b57b-482f6e59a810spl_set_idee9ad9ed-6d9f-4ee1-9d7f-cfad438df388Package NDC 0071-0803-24, 0071-0803-40, 0071-0805-24, 0071-0805-40, 0071-0806-24, 0071-0806- ... NUIN0000175753, N0000008486Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII6CW7F3G59X

26)

drugcharacterization2medicinalproductMULTIVITAMINdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb63drugcumulativedosageunit032drugdosagetext1 DF, TIDdrugstartdateformat102drugstartdate19/04/2011drugenddateformat102drugenddate09/05/2011

27)

drugcharacterization2medicinalproductLYRICAdrugstructuredosagenumb75drugstructuredosageunit003drugdosagetext75 MG, UNK

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

28)

drugcharacterization2medicinalproductZOLPIDEMdrugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG, UNK

openFDA Info on Medication

Application NumberANDA077214Brand NameZOLPIDEMGeneric NameZOLPIDEM TARTRATEManufacturersACI Healthcare USA, Incproduct_ndc71093-155, 71093-156Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsZOLPIDEM TARTRATERXCUI854873, 854876spl_idad76e67e-f0d0-4f39-b3d8-68d43560b07fspl_set_id021153ce-fe27-4ed1-8d88-b4157b0ed734Package NDC71093-155-06, 71093-155-04, 71093-156-04, 71093-156-06UNIIWY6W63843K

29)

drugcharacterization2medicinalproductCLONAZEPAMdrugstructuredosagenumb.5drugstructuredosageunit003drugdosagetext0.5 MG, UNK

openFDA Info on Medication

Application Number ANDA077171, ANDA074569, ANDA074869, ANDA077194, ANDA077147, ANDA074979, ANDA2110 ... Brand NameCLONAZEPAM, KLONOPINGeneric NameCLONAZEPAMManufacturers Par Pharmaceutical, Inc., Teva Pharmaceuticals USA, Inc., Actavis Pharma, Inc., ... product_ndc 49884-306, 49884-307, 49884-308, 49884-309, 49884-310, 0093-0832, 0093-3212, 009 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONAZEPAMRXCUI 349194, 349195, 349196, 349197, 349198, 197527, 197528, 197529, 206157, 206159, ... spl_id a95f8799-0bb3-41d6-aa27-8a291127ad54, 90dc0b61-37a3-4e54-bde3-7e4c3f7dae98, 9b58 ... spl_set_id 1aef0069-80ea-483d-ac70-c8d485462c5b, 8069b1a0-7c06-4252-b44e-e2eef065d9b8, a58f ... Package NDC 49884-306-02, 49884-307-02, 49884-308-02, 49884-309-02, 49884-310-02, 0093-0832- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII5PE9FDE8GB

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drugcharacterization2medicinalproductMS CONTINdrugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb4200drugcumulativedosageunit003drugdosagetext100 MG, BIDdrugindicationPAINdrugstartdateformat102drugstartdate19/04/2011drugenddateformat102drugenddate09/05/2011

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Application NumberNDA019516Brand NameMS CONTINGeneric NameMORPHINE SULFATEManufacturersRhodes Pharmaceuticals L.P.product_ndc42858-515, 42858-631, 42858-760, 42858-799, 42858-900Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMORPHINE SULFATERXCUI891874, 891881, 891888, 891893, 892560, 892574, 892646, 892648, 892660, 894813spl_id018d2e3f-c076-48e4-b1ee-b4c1bdb082e6spl_set_idc354b3bf-86c0-4bb8-8b1f-be2164942698Package NDC 42858-515-01, 42858-631-01, 42858-631-50, 42858-760-01, 42858-760-50, 42858-799- ... UNIIX3P646A2J0

31)

drugcharacterization2medicinalproductFENTANYL

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Application NumberNDA022569, ANDA202097, ANDA077449, NDA021947, NDA202788, NDA019813, ANDA076258Brand NameLAZANDA, FENTANYL SYSTEM, FENTANYL, FENTORA, SUBSYS, DURAGESIC (FENTANYL SYSTEM)Generic NameFENTANYLManufacturers West Therapeutic Development LLC, Alvogen, Apotex Corp., Cephalon, Inc., Insys T ... product_ndc 71500-110, 71500-140, 71500-130, 47781-423, 47781-424, 47781-426, 47781-427, 477 ... Product TypeHUMAN PRESCRIPTION DRUGRouteNASAL, TRANSDERMAL, BUCCAL, SUBLINGUALActive IngredientsFENTANYL CITRATE, FENTANYLRXCUI 1115573, 1115575, 1115577, 1115579, 1729320, 1729322, 197696, 245134, 245135, 24 ... spl_id 9f5c9d6b-1f8a-0f2e-e053-2a95a90a1458, b9f82be8-5426-7518-e053-2995a90abd81, 4696 ... spl_set_id 73f38bde-2132-2b5a-e053-2a91aa0a6efb, 242759ef-cb6d-4e3e-9f8d-5e31efa1f289, 0ff7 ... Package NDC 71500-140-01, 71500-130-01, 71500-110-01, 47781-423-47, 47781-424-47, 47781-426- ... UNIIMUN5LYG46H, UF599785JZNUIN0000175684, N0000175690Mechanism of ActionFull Opioid Agonists [MoA]Established Pharmacologic ClassOpioid Agonist [EPC]

32)

drugcharacterization2medicinalproductMORPHINE

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Brand NameOPIUM TINCTURE DEODORIZEDGeneric NameMORPHINEManufacturersEdenbridge Pharmaceuticals, LLCproduct_ndc42799-217Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMORPHINERXCUI830196spl_id5b376952-010f-adfc-e053-2a91aa0ae464spl_set_ide2a5697a-cc41-4cf1-b3a8-59b0268740d7Package NDC42799-217-01, 42799-217-02NUIN0000175684, N0000175690Mechanism of ActionFull Opioid Agonists [MoA]Established Pharmacologic ClassOpioid Agonist [EPC]UNII76I7G6D29C

33)

drugcharacterization2medicinalproductVENLAFAXINE

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Application Number ANDA211323, ANDA079098, ANDA206250, ANDA078627, ANDA078932, ANDA090555, ANDA0776 ... Brand NameVENLAFAXINE, VENLAFAXINE HYDROCHLORIDEGeneric NameVENLAFAXINE, VENLAFAXINE HYDROCHLORIDEManufacturers Cadila Pharmaceuticals Limited, Amneal Pharmaceuticals LLC, Sun Pharmaceutical I ... product_ndc 71209-087, 71209-088, 71209-089, 65162-300, 65162-302, 65162-306, 65162-307, 651 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsVENLAFAXINE HYDROCHLORIDERXCUI808744, 808748, 808753, 313580, 313582, 313584, 313586, 314277, 808751spl_id f0cda912-3f9e-4f18-a55e-a5cc80bd2e7a, 11f387e7-a398-4a1f-90d8-7454e9bd499d, a3b2 ... spl_set_id 516e7566-35c2-4a25-88d8-54d9dbc8f6be, 62c02cdb-ea65-41ff-a531-4d9ea498f705, 2ed6 ... Package NDC 71209-087-01, 71209-087-04, 71209-087-11, 71209-088-01, 71209-088-04, 71209-088- ... UNII7D7RX5A8MO

34)

drugcharacterization2medicinalproductADVAIR

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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

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