Adverse Event Report

Report

Version of Safety Report ID3Safety Report ID11074807primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate06/02/2017reporttype1serious1seriousnesshospitalization1seriousnessdisabling1receivedateformat102Date Received29/04/2015receiptdateformat102Date Last Updated07/10/2016fulfillexpeditecriteria1companynumbUS-BAYER-2015-162319duplicate1

Report Duplicate

duplicatesourceBAYERduplicatenumbUS-BAYER-2015-162319

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age25Unit of Onset Ageyearspatientagegroup5SexFemale

Reaction

1)

reactionmeddraversionpt19.1ReactionIntracranial pressure increasedOutcomeRecovered/resolved

2)

reactionmeddraversionpt19.1ReactionVision blurredOutcomeRecovered/resolved

3)

reactionmeddraversionpt19.1ReactionTinnitusOutcomeRecovered/resolved

4)

reactionmeddraversionpt19.1ReactionHeadacheOutcomeRecovered/resolved

5)

reactionmeddraversionpt19.1ReactionDiplopiaOutcomeRecovered/resolved

6)

reactionmeddraversionpt19.1ReactionPainOutcomeRecovered/resolved

7)

reactionmeddraversionpt19.1ReactionPapilloedemaOutcomeRecovered/resolved

8)

reactionmeddraversionpt19.1ReactionInjuryOutcomeRecovered/resolved

9)

reactionmeddraversionpt19.1ReactionBenign intracranial hypertensionOutcomeRecovered/resolved

10)

reactionmeddraversionpt19.1ReactionMigraineOutcomeRecovered/resolved

11)

reactionmeddraversionpt19.1ReactionVisual impairmentOutcomeRecovered/resolved

Drug

1)

drugcharacterization2medicinalproductDIAMOX SEQUELS

activesubstance

activesubstancenameACETAZOLAMIDE

2)

drugcharacterization2medicinalproductDILAUDID

activesubstance

activesubstancenameHYDROMORPHONE HYDROCHLORIDE

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, 6cac ... 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

3)

drugcharacterization2medicinalproductDRAMAMINEdrugindicationDIZZINESS

activesubstance

activesubstancenameDIMENHYDRINATE

openFDA Info on Medication

Application Numberpart336Brand NameDRAMAMINEGeneric NameDIMENHYDRINATE, MECLIZINE HYDROCHLORIDEManufacturersLil' Drug Store Products, Inc., Mechanical Servants, LLC, Medtech Products Inc.product_ndc66715-9809, 29485-1216, 29485-6925, 29485-8048, 63029-906Product TypeHUMAN OTC DRUGRouteORALActive IngredientsDIMENHYDRINATE, MECLIZINE HYDROCHLORIDERXCUI309913, 602223, 995632, 2176732spl_id c72c2be2-d554-8eb3-e053-2a95a90ab8fc, cee22d00-e8a2-d735-e053-2995a90aec04, bcb6 ... spl_set_id 960a642b-ee7c-4e92-9b5f-930425682dac, cee22d00-e8a1-d735-e053-2995a90aec04, f8cf ... Package NDC66715-9809-1, 29485-6925-3, 29485-1216-2, 29485-8048-2, 63029-906-12UNIIJB937PER5C, HDP7W44CIO

4)

drugcharacterization2medicinalproductFENTANYL CITRATE.

activesubstance

activesubstancenameFENTANYL CITRATE

openFDA Info on Medication

Application Number NDA019115, NDA020747, NDA019101, NDA021947, ANDA078907, ANDA212086, ANDA210762, ... Brand NameFENTANYL CITRATE, FENTANYL BUCCAL, ACTIQGeneric NameFENTANYL CITRATEManufacturers Hospira, Inc., Teva Pharmaceuticals USA, Inc., Hikma Pharmaceuticals USA Inc., M ... product_ndc 0409-9093, 0409-9094, 0093-7865, 0093-7866, 0093-7867, 0093-7868, 0093-7869, 009 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORAL, TRANSMUCOSAL, BUCCAL, SUBLINGUALActive IngredientsFENTANYL CITRATERXCUI 1735003, 310293, 310294, 310295, 310297, 313992, 313993, 1735007, 1735008, 17350 ... spl_id 268fba14-76ac-4b8d-810c-124f37228d91, dfb04705-85fe-46ee-b735-4e4bfc7f8063, 4b40 ... spl_set_id 1ed25b2c-334e-4021-ada1-3396f07630dc, 78221eab-66fd-4cd8-9c81-af52eb83671c, ce5d ... Package NDC 0409-9093-09, 0409-9093-11, 0409-9094-09, 0409-9094-11, 0093-7865-19, 0093-7865- ... UNIIMUN5LYG46H

5)

drugcharacterization2medicinalproductSENOKOT

activesubstance

activesubstancenameSENNOSIDES

openFDA Info on Medication

Application Numberpart334Brand NameSENOKOTGeneric NameSTANDARDIZED SENNA CONCENTRATEManufacturersAvrio Health L.P.product_ndc67618-300, 67618-120Product TypeHUMAN OTC DRUGRouteORALActive IngredientsSENNOSIDESRXCUI312935, 404186, 602802, 1039965spl_idb86ea34d-113e-48d8-a43c-732f25a0d7c0, 704634b0-f1bf-4030-82d6-76bbb8879131spl_set_idc18dd7fa-993b-440b-8cdd-f1551abb99ca, d5bf67e5-82c6-edbf-e9ec-e027fdd47c84Package NDC 67618-300-20, 67618-300-50, 67618-300-10, 67618-120-12, 67618-120-36, 67618-120- ... UNII3FYP5M0IJX

6)

drugcharacterization2medicinalproductBENADRYL

activesubstance

activesubstancenameDIPHENHYDRAMINE HYDROCHLORIDE

openFDA Info on Medication

Application Numberpart341Brand NameCHILDRENS ALLERGY RELIEF, BENADRYLGeneric NameBENADRYL, DIPHENHYDRAMINE HYDROCHLORIDEManufacturers Rite Aid Corporation, Johnson & Johnson Consumer Inc., McNeil Consumer Healthcar ... product_ndc11822-0025, 50580-370, 29485-1007, 29485-6931, 29485-7963, 50580-226Product TypeHUMAN OTC DRUGRouteORALActive IngredientsDIPHENHYDRAMINE HYDROCHLORIDERXCUI1049906, 1049630, 1049632spl_id fecb0ac3-0ede-4e4a-91c3-b6322f055b5c, dfd36d48-2977-7b2d-e053-2a95a90a82a8, e3b6 ... spl_set_id 50434eaf-650c-4416-a357-d174f86d729f, 2884d2dc-2d4a-4ca6-ab73-688a80b428eb, 53de ... Package NDC 11822-0025-4, 50580-370-01, 29485-6931-6, 29485-7963-2, 29485-7963-3, 29485-1007 ... UNIITC2D6JAD40

7)

drugcharacterization2medicinalproductDIMENHYDRINATE.

activesubstance

activesubstancenameDIMENHYDRINATE

openFDA Info on Medication

Application Numberpart336, ANDA040519Brand Name MOTION SICKNESS, MOTION SICKNESS RELIEF, DRAMAMINE ORANGE, DIMENHYDRINATE, PHYSI ... Generic NameDIMENHYDRINATEManufacturers Strategic Sourcing Services, LLC (Health Mart), WinCo Foods, LLC, Medtech Produc ... product_ndc 62011-0341, 67091-118, 63029-902, 36800-930, 50844-199, 69842-206, 0924-1006, 11 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsDIMENHYDRINATERXCUI 198603, 309913, 602223, 211482, 201716, 755901, 2594768, 1245184, 1245186, 10869 ... spl_id 0535dd13-fd90-4cf2-8765-d26058f623c9, 916a27b5-ae4d-450d-98a4-bd89ee0f35d3, 7d7e ... spl_set_id 60fef11b-75df-450c-a3e7-b70c88e65ed3, be8b1af8-bf84-4de5-afc7-a04d420d918f, 7616 ... Package NDC 62011-0341-1, 67091-118-12, 63029-902-01, 63029-902-02, 63029-902-04, 36800-930- ... UNIIJB937PER5C

8)

drugcharacterization2medicinalproductTIZANIDINE.

activesubstance

activesubstancenameTIZANIDINE

openFDA Info on Medication

Application NumberANDA076416, ANDA211798, ANDA208187, ANDA076533, ANDA076286, ANDA091283Brand NameTIZANIDINEGeneric NameTIZANIDINEManufacturers Sun Pharmaceutical Industries, Inc., Ascend Laboratories, LLC, Cadila Healthcare ... product_ndc 57664-502, 57664-503, 67877-613, 67877-614, 70771-1335, 70771-1336, 60505-0251, ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTIZANIDINE HYDROCHLORIDERXCUI313412, 313413spl_id 5e8ef5b3-9f58-46a7-833c-31ef018ea9a0, 4904688c-ba48-4db8-8720-4e6e99a6460e, 1723 ... spl_set_id 4659df31-8b89-4eff-9d86-7b7e38de416b, 72f25135-1333-4e52-83f5-7df7d90e68bb, 8910 ... Package NDC 57664-502-89, 57664-502-18, 57664-503-89, 57664-503-18, 67877-613-15, 67877-613- ... UNIIB53E3NMY5C

9)

drugcharacterization2medicinalproductLASIX

activesubstance

activesubstancenameFUROSEMIDE

openFDA Info on Medication

Application NumberNDA016273Brand NameLASIXGeneric NameFUROSEMIDEManufacturersValidus Pharmaceuticals LLCproduct_ndc30698-060, 30698-067, 30698-066Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFUROSEMIDERXCUI197732, 200801, 200809, 205732, 310429, 313988spl_id95a46760-e587-41a3-9ff3-c8dd8505f694spl_set_id2c9b4d8f-0770-482d-a9e6-9c616a440b1aPackage NDC 30698-067-01, 30698-067-10, 30698-060-01, 30698-060-10, 30698-060-50, 30698-066- ... NUIN0000175366, N0000175590Physiologic/Pharmacodynamic EffectIncreased Diuresis at Loop of Henle [PE]Established Pharmacologic ClassLoop Diuretic [EPC]UNII7LXU5N7ZO5

10)

drugcharacterization2medicinalproductTRAZODONE

activesubstance

activesubstancenameTRAZODONE HYDROCHLORIDE

openFDA Info on Medication

11)

drugcharacterization2medicinalproductINDERAL

activesubstance

activesubstancenamePROPRANOLOL HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA018553Brand NameINDERAL LAGeneric NamePROPRANOLOL HYDROCHLORIDEManufacturersANI Pharmaceuticals, Inc.product_ndc62559-520, 62559-521, 62559-522, 62559-523Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPROPRANOLOL HYDROCHLORIDERXCUI856460, 856462, 856481, 856483, 856535, 856537, 856569, 856571spl_idc5f105d2-6601-4538-b70d-b094694b15f6spl_set_id35d28979-36b1-4630-b85e-a44e0a443734Package NDC62559-520-01, 62559-521-01, 62559-522-01, 62559-523-01UNIIF8A3652H1V

12)

drugcharacterization2medicinalproductLUNESTA

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application NumberNDA021476Brand NameLUNESTAGeneric NameESZOPICLONEManufacturersSunovion Pharmaceuticals Inc.product_ndc63402-190, 63402-191, 63402-193Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id4c2704d7-3027-4240-9073-3f0b24cf15b5spl_set_idfd047b2b-05a6-4d99-95cb-955f14bf329fPackage NDC 63402-190-30, 63402-191-03, 63402-191-10, 63402-191-01, 63402-191-30, 63402-193- ... UNIIUZX80K71OE

13)

drugcharacterization2medicinalproductALLEGRA

activesubstance

activesubstancenameFEXOFENADINE HYDROCHLORIDE

14)

drugcharacterization2medicinalproductOXYCODONE

activesubstance

activesubstancenameOXYCODONE

openFDA Info on Medication

Application NumberANDA203638, NDA208090, ANDA211748, ANDA211749Brand NameOXYCODONE HYDROCHLORIDE, XTAMPZA ER, OXYCODONEGeneric NameOXYCODONEManufacturers Amneal Pharmaceuticals LLC, Collegium Pharmaceutical, Inc., Ascend Laboratories, ... product_ndc 65162-047, 65162-048, 65162-049, 65162-050, 65162-051, 24510-110, 24510-115, 245 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOXYCODONE HYDROCHLORIDE, OXYCODONERXCUI 1049611, 1049618, 1049621, 1049683, 1049686, 1790527, 1790533, 1791558, 1791560, ... spl_id 65642e87-702d-404b-9d4c-816f116c7664, 1f9ccc6c-e3be-4e4b-a5e0-cfdf69253a2b, d906 ... spl_set_id 094b64b3-cd32-4de5-afb6-ea00d9caad74, b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c, 08b2 ... Package NDC 65162-047-03, 65162-047-10, 65162-047-25, 65162-047-50, 65162-048-03, 65162-048- ... UNIIC1ENJ2TE6C, CD35PMG570NUIN0000175684, N0000175690Mechanism of ActionFull Opioid Agonists [MoA]Established Pharmacologic ClassOpioid Agonist [EPC]

15)

drugcharacterization2medicinalproductCITALOPRAM

activesubstance

activesubstancenameCITALOPRAM HYDROBROMIDE

openFDA Info on Medication

Application Number ANDA077048, ANDA077043, NDA215428, ANDA077534, ANDA077042, ANDA077031, ANDA07728 ... Brand NameCITALOPRAM, CITALOPRAM HYDROBROMIDE, CELEXAGeneric NameCITALOPRAM TABLETS, CITALOPRAM TABLET, CITALOPRAM, CITALOPRAM HYDROBROMIDEManufacturers Cosette Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Almatica Pharma L ... product_ndc 0713-4740, 0713-4741, 0713-4742, 0054-0062, 52427-691, 69097-822, 69097-823, 690 ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteORALActive IngredientsCITALOPRAM HYDROBROMIDE, CITALOPRAMRXCUI200371, 283672, 309314, 309313, 2591786, 213344, 213345, 284591spl_id 8eadc3e4-81a3-4b3b-aa1c-1dc65151f94c, 3b571c67-5234-44ad-8276-e29b1ceabec3, bde4 ... spl_set_id cf7b6823-108b-ebff-8f41-91f8b8325e3a, 29408d84-7b00-4cee-969c-8095f8083ff5, 2f81 ... Package NDC 0713-4740-01, 0713-4740-05, 0713-4741-01, 0713-4741-05, 0713-4742-01, 0713-4742- ... UNIII1E9D14F36, 0DHU5B8D6VNUIN0000175696, N0000000109Established Pharmacologic ClassSerotonin Reuptake Inhibitor [EPC]Mechanism of ActionSerotonin Uptake Inhibitors [MoA]

16)

drugcharacterization2medicinalproductFIORICET

activesubstance

activesubstancenameACETAMINOPHEN\BUTALBITAL\CAFFEINE

openFDA Info on Medication

Application NumberANDA040885Brand NameFIORICETGeneric NameBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEManufacturersActavis Pharma, Inc.product_ndc52544-080Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsACETAMINOPHEN, BUTALBITAL, CAFFEINERXCUI889520, 1432261spl_id14ca4151-a727-4708-8e35-8eb08e175db8spl_set_idc018be7d-f7b8-45e2-97b8-8e7a71740657Package NDC52544-080-01NUIN0000175693, M0002177, N0000175739, N0000175729, N0000175790, M0023046Established Pharmacologic ClassBarbiturate [EPC], Central Nervous System Stimulant [EPC], Methylxanthine [EPC]Chemical StructureBarbiturates [CS], Xanthines [CS]Physiologic/Pharmacodynamic EffectCentral Nervous System Stimulation [PE]UNII362O9ITL9D, KHS0AZ4JVK, 3G6A5W338E

17)

drugcharacterization1medicinalproductMIRENAdrugbatchnumb83457Adrugauthorizationnumb021225drugstructuredosagenumb20drugstructuredosageunit004drugdosagetext20 MCG/24HR, CONTdrugdosageformINTRAUTERINE DELIVERY SYSTEMdrugadministrationroute015drugindicationCONTRACEPTIONdrugstartdateformat102drugstartdate22/04/2009drugenddateformat610drugenddate/05/2013actiondrug4

activesubstance

activesubstancenameLEVONORGESTREL

openFDA Info on Medication

Application NumberNDA021225Brand NameMIRENAGeneric NameLEVONORGESTRELManufacturersBayer HealthCare Pharmaceuticals Inc.product_ndc50419-423Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAUTERINEActive IngredientsLEVONORGESTRELRXCUI804156, 807283spl_id21ce3b07-0588-4ac3-915b-d1c238d756easpl_set_iddcbd6aa2-b3fa-479a-a676-56ea742962fcPackage NDC50419-423-01, 50419-423-08NUIN0000175830, M0447349, N0000175602, N0000175832Physiologic/Pharmacodynamic EffectInhibit Ovum Fertilization [PE]Chemical StructureProgesterone Congeners [CS]Established Pharmacologic ClassProgestin [EPC], Progestin-containing Intrauterine Device [EPC]UNII5W7SIA7YZW

18)

drugcharacterization2medicinalproductPHENERGANdrugindicationNAUSEA

activesubstance

activesubstancenamePROMETHAZINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA083312Brand NamePHENERGANGeneric NamePROMETHAZINE HYDROCHLORIDEManufacturersHikma Pharmaceuticals USA Inc.product_ndc0641-6082, 0641-6083, 0641-6084, 0641-6085Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUSActive IngredientsPROMETHAZINE HYDROCHLORIDEspl_ide134cda8-8ad2-4863-906b-83e57303806c, bc2d8f01-1268-4bb2-8db9-793866d32782spl_set_id6f7e47cc-f823-4336-8107-f980e3049617, 481866da-a712-48a5-853f-8e84aacaab6dPackage NDC 0641-6082-01, 0641-6082-25, 0641-6083-01, 0641-6083-25, 0641-6084-01, 0641-6084- ... UNIIR61ZEH7I1IRXCUI992460, 992462, 992858, 992876

19)

drugcharacterization2medicinalproductZOFRAN

activesubstance

activesubstancenameONDANSETRON HYDROCHLORIDE

20)

drugcharacterization2medicinalproductREGLAN

activesubstance

activesubstancenameMETOCLOPRAMIDE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA017854Brand NameREGLANGeneric NameMETOCLOPRAMIDE HYDROCHLORIDEManufacturersANI Pharmaceuticals, Inc.product_ndc62559-165, 62559-166Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETOCLOPRAMIDE HYDROCHLORIDERXCUI207265, 207266, 311666, 311668spl_id06daee34-5164-4630-af92-bc43fa9c295dspl_set_idde55c133-eb08-4a35-91a2-5dc093027397Package NDC62559-165-01, 62559-166-01UNIIW1792A2RVD

21)

drugcharacterization2medicinalproductVERSED

activesubstance

activesubstancenameMIDAZOLAM HYDROCHLORIDE

22)

drugcharacterization2medicinalproductIMITREX

activesubstance

activesubstancenameSUMATRIPTAN SUCCINATE

openFDA Info on Medication

Application NumberNDA020080, NDA020132, NDA020626Brand NameIMITREXGeneric NameSUMATRIPTANManufacturersGlaxoSmithKline LLCproduct_ndc 0173-0478, 0173-0739, 0173-0479, 0173-0735, 0173-0736, 0173-0737, 0173-0523, 017 ... Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUS, ORAL, NASALActive IngredientsSUMATRIPTAN SUCCINATE, SUMATRIPTANRXCUI 758523, 860088, 1657160, 1657173, 208450, 209169, 284460, 313160, 313161, 315223 ... spl_id ae0a5f62-ace2-491d-bcb4-49c28bf1e0f1, db469bf0-d651-450f-87cb-9fcaa88459be, 7aca ... spl_set_id fee7d073-0b99-48f2-7985-0d8cf970894b, 584abe73-8290-4484-ff8e-5890831c095e, cc11 ... Package NDC 0173-0739-00, 0173-0739-02, 0173-0479-00, 0173-0478-00, 0173-0735-00, 0173-0736- ... UNIIJ8BDZ68989, 8R78F6L9VONUIN0000175763, N0000175764, N0000175765Mechanism of ActionSerotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA]Established Pharmacologic ClassSerotonin-1b and Serotonin-1d Receptor Agonist [EPC]

23)

drugcharacterization2medicinalproductCARBAMAZEPINE.

activesubstance

activesubstancenameCARBAMAZEPINE

openFDA Info on Medication

Application Number ANDA212948, ANDA076697, ANDA070541, NDA206030, ANDA214328, ANDA073524, ANDA21162 ... Brand Name CARBAMAZEPINE ER, CARBAMAZEPINE, EPITOL, CARNEXIV, TEGRETOL, TEGRETOL XR, CARBAM ... Generic NameCARBAMAZEPINEManufacturers Eywa Pharma Inc, Nostrum Laboratories, Inc., Teva Pharmaceuticals USA, Inc., Lun ... product_ndc 71930-072, 71930-073, 71930-074, 29033-004, 29033-019, 29033-020, 0093-0090, 673 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsCARBAMAZEPINERXCUI 199378, 402505, 402506, 200131, 200133, 388311, 211817, 308979, 2119860, 2119862 ... spl_id fe788fd8-8083-4201-af83-010af795d108, 9fcd6487-e123-44ca-a48f-3aa2e5858979, 6a0f ... spl_set_id 48010b2b-526b-4bd6-87fd-87745c22cb8f, fbca2152-0022-47a5-a1ea-58950b45bcbf, 32bb ... Package NDC 71930-072-12, 71930-073-12, 71930-074-90, 71930-074-12, 29033-019-12, 29033-020- ... NUI N0000008486, N0000175751, N0000185506, N0000191266, N0000187064, N0000185507, N0 ... Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]Established Pharmacologic ClassMood Stabilizer [EPC]Mechanism of Action Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochro ... UNII33CM23913M

24)

drugcharacterization2medicinalproductCYMBALTA

activesubstance

activesubstancenameDULOXETINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021427Brand NameCYMBALTAGeneric NameDULOXETINE HYDROCHLORIDEManufacturersEli Lilly and Companyproduct_ndc0002-3235, 0002-3240, 0002-3270Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDULOXETINE HYDROCHLORIDERXCUI596926, 596928, 596930, 596932, 596934, 615186spl_id892f05de-dd11-4ae3-9a85-ce9cfcbeaaccspl_set_id2f7d4d67-10c1-4bf4-a7f2-c185fbad64baPackage NDC0002-3235-60, 0002-3240-30, 0002-3240-90, 0002-3270-30, 0002-3270-04UNII9044SC542W

25)

drugcharacterization2medicinalproductMIDAZOLAM

activesubstance

activesubstancenameMIDAZOLAM\MIDAZOLAM HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA075243, NDA211321, ANDA075154, ANDA090850, ANDA203460, ANDA075494, ANDA20887 ... Brand NameMIDAZOLAM, NAYZILAMGeneric NameMIDAZOLAM, MIDAZOLAM HYDROCHLORIDEManufacturers Hikma Pharmaceuticals USA Inc., UCB, Inc., Fresenius Kabi USA, LLC, Almaject, In ... product_ndc 0641-6190, 50474-500, 63323-411, 63323-412, 0641-6209, 0641-6210, 0641-6211, 726 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, NASALActive IngredientsMIDAZOLAM HYDROCHLORIDE, MIDAZOLAMRXCUI311702, 2173494, 2173500, 311700, 998211, 1551393, 1551395, 1666798, 1666800spl_id 09e2995b-4a40-4346-9305-42421b5e1b85, d482be4b-6617-4aa5-bc25-5aed7ef03480, 8ef4 ... spl_set_id f8bb3427-c887-47b6-8042-8a21dc161c79, 2b29422e-54d5-4a49-8522-e9cf752368c3, a91c ... Package NDC 0641-6190-01, 0641-6190-10, 50474-500-14, 50474-500-15, 63323-411-15, 63323-411- ... UNIIW7TTW573JJ, R60L0SM5BCNUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]

26)

drugcharacterization2medicinalproductNICORETTE

activesubstance

activesubstancenameNICOTINE

openFDA Info on Medication

Application NumberNDA021330, NDA022360, NDA018612, NDA020066Brand Name NICORETTE, NICORETTE ORIGINAL, NICORETTE FRESH MINT, NICORETTE MINT, NICORETTE S ... Generic NameNICOTINE POLACRILEXManufacturersGlaxoSmithKline Consumer Healthcare Holdings (US) LLCproduct_ndc 0135-0625, 0135-0626, 0135-1500, 0135-2800, 0135-0508, 0135-0509, 0135-0157, 013 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsNICOTINERXCUI359817, 359818, 968849, 968851, 105071, 209326, 311975, 314119spl_id c15288fe-8c1b-4de3-a54f-b193e313e29e, c7f32ab1-f6bd-46f5-9852-8eb5b78a3326, b26e ... spl_set_id f350e050-2173-43e0-8738-848382ce0700, c7f32ab1-f6bd-46f5-9852-8eb5b78a3326, fdee ... Package NDC 0135-0625-01, 0135-0625-02, 0135-0625-03, 0135-0626-01, 0135-0626-02, 0135-0626- ... NUIN0000175706, M0014836Established Pharmacologic ClassCholinergic Nicotinic Agonist [EPC]Chemical StructureNicotine [CS]UNII6M3C89ZY6R

27)

drugcharacterization2medicinalproductPROPRANOLOL HCL W/HYDROCHLOROTHIAZIDE

28)

drugcharacterization2medicinalproductNICOTROL

activesubstance

activesubstancenameNICOTINE

openFDA Info on Medication

Application NumberNDA020385, NDA020714Brand NameNICOTROLGeneric NameNICOTINEManufacturersPharmacia & Upjohn Company LLCproduct_ndc0009-5401, 0009-5400Product TypeHUMAN PRESCRIPTION DRUGRouteNASAL, RESPIRATORY (INHALATION)Active IngredientsNICOTINERXCUI1797886, 1797888, 250983, 1046920spl_id81c50c19-8c24-4258-9a63-7b01f42e7ff6, 00c25938-fb91-4e66-ac58-11b6e10d6d3aspl_set_idacb7d02d-249b-4645-ac1b-8ff9a56dd244, 62245d7d-b50d-48d9-9f03-071c61620ccfPackage NDC0009-5401-01, 0009-5400-01NUIN0000175706, M0014836Established Pharmacologic ClassCholinergic Nicotinic Agonist [EPC]Chemical StructureNicotine [CS]UNII6M3C89ZY6R

29)

drugcharacterization2medicinalproductMIRALAX

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_idd7a274a0-b5a1-1a00-e053-2a95a90a0387spl_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

30)

drugcharacterization2medicinalproductSEROQUEL

activesubstance

activesubstancenameQUETIAPINE FUMARATE

openFDA Info on Medication

Application NumberNDA022047, NDA020639Brand NameSEROQUEL XR, SEROQUELGeneric NameQUETIAPINEManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0310-0280, 0310-0282, 0310-0283, 0310-0284, 0310-0281, 0310-0271, 0310-0275, 031 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsQUETIAPINE FUMARATERXCUI 721791, 721793, 721794, 721795, 721796, 721797, 853201, 853202, 895670, 895671, ... spl_idc3b26ed5-6f3a-4ca5-80a5-b98380040294, 37cb4cbf-8192-4921-b17c-e562467fc018spl_set_id473a3ac4-67f4-4782-baa9-7f9bdd8761f4, 0584dda8-bc3c-48fe-1a90-79608f78e8a0Package NDC 0310-0282-39, 0310-0282-94, 0310-0282-60, 0310-0283-39, 0310-0283-55, 0310-0283- ... UNII2S3PL1B6UJ

31)

drugcharacterization2medicinalproductZANAFLEX

activesubstance

activesubstancenameTIZANIDINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020397, NDA021447Brand NameZANAFLEXGeneric NameTIZANIDINE HYDROCHLORIDEManufacturersCovis Pharma US, Incproduct_ndc70515-594, 70515-602, 70515-604, 70515-606Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTIZANIDINE HYDROCHLORIDERXCUI153735, 313413, 485484, 485485, 485486, 580267, 583165, 583211spl_id4caebc2e-bf10-442a-b24d-c3b51876c67fspl_set_id043d9e51-bfa2-4add-9058-5ece332f7e99Package NDC70515-602-15, 70515-604-15, 70515-606-15, 70515-594-15UNIIB53E3NMY5C

32)

drugcharacterization2medicinalproductHYPROMELLOSE

activesubstance

activesubstancenameHYPROMELLOSES

openFDA Info on Medication

Application Numberpart349Brand NameSPLASH TEARS, ROHTO JOLT, SYSTANE, GENTEAL TEARS SEVEREGeneric NameHYPROMELLOSEManufacturers LABORATORIOS SOPHIA, S.A. DE C.V., The Mentholatum Company, Alcon Laboratories, ... product_ndc57619-303, 10742-8194, 0065-0474, 0065-8064Product TypeHUMAN OTC DRUGRouteOPHTHALMICActive IngredientsHYPROMELLOSE 2910 (4000 MPA.S), HYPROMELLOSE 2906 (4000 MPA.S)RXCUI359634, 1946824, 310932, 793204spl_id d2a5f033-8751-991a-e053-2995a90a9cb1, 8f87439c-2fd4-429f-b00f-38de7ed127de, e26b ... spl_set_id a58a8478-9cc5-aa39-e053-2995a90a347d, 0dc29577-6b66-428b-a46b-546973654841, 5f74 ... Package NDC 57619-303-01, 57619-303-03, 10742-8194-1, 0065-0474-01, 0065-0474-02, 0065-8064- ... UNIIRN3152OP35, 5EYA69XGAT

33)

drugcharacterization2medicinalproductACETAMINOPHEN.

activesubstance

activesubstancenameACETAMINOPHEN

openFDA Info on Medication

Application Number part343, ANDA211544, ANDA075077, ANDA076200, NDA019872, ANDA070607, ANDA207035, ... Brand Name ACETAMINOPHEN, TYLENOL ACETAMINOPHEN EXTRA STRENGTH, PAIN RELIEVER EXTRA STRENGT ... Generic Name ACETAMINOPHEN, ACETAMINOPHEN,, ACETAMINOPHEN TABLET EXTENDED RELEASE, ACETAMINOP ... Manufacturers Major Pharmaceuticals, Mechanical Servants, LLC, L.N.K. International, Inc., AME ... product_ndc 0904-6719, 29485-1887, 29485-7025, 29485-7003, 29485-6926, 50844-519, 46122-629, ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, RECTAL, INTRAVENOUSActive Ingredients ACETAMINOPHEN, ASPIRIN, CAFFEINE, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCC ... RXCUI 313782, 198440, 209459, 1148399, 307668, 828555, 198439, 313820, 1243440, 198434 ... spl_id 4612b5f6-4120-4364-a6f8-b43d15d0caf8, e42a3015-18e1-0c56-e053-2a95a90ad743, ab4b ... spl_set_id 5483b704-88c0-4176-a04c-f8b2b85e8c57, 68bb463c-91af-4eca-b2d5-9d134a756a45, 72ba ... Package NDC 0904-6719-50, 0904-6719-60, 0904-6719-80, 29485-7025-2, 29485-1887-4, 29485-7003 ... UNII 362O9ITL9D, R16CO5Y76E, 3G6A5W338E, 9D2RTI9KYH, V9BI9B5YI2, 04JA59TNSJ, TC2D6JAD ... NUI N0000000160, N0000008836, M0001335, N0000175722, N0000175578, N0000008832, N0000 ... Mechanism of ActionCyclooxygenase Inhibitors [MoA]Physiologic/Pharmacodynamic Effect Decreased Prostaglandin Production [PE], Decreased Platelet Aggregation [PE], Ce ... Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS], Xanthines [CS]Established Pharmacologic Class Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], ...

34)

drugcharacterization2medicinalproductPROMETHAZINE

activesubstance

activesubstancenamePROMETHAZINE\PROMETHAZINE HYDROCHLORIDE

openFDA Info on Medication

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

35)

drugcharacterization2medicinalproductGABAPENTIN.

activesubstance

activesubstancenameGABAPENTIN

openFDA Info on Medication

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

summary

narrativeincludeclinicalCASE EVENT DATE: 201001