Adverse Event Report

Report

Version of Safety Report ID2Safety Report ID11758994primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate04/03/2016reporttype2serious1seriousnesshospitalization1seriousnessother1receivedateformat102Date Received20/11/2015receiptdateformat102Date Last Updated24/12/2015fulfillexpeditecriteria1companynumbUS-ABBVIE-15K-163-1500737-00duplicate1

Report Duplicate

duplicatesourceABBVIEduplicatenumbUS-ABBVIE-15K-163-1500737-00

Primary Source

reportercountryCOUNTRY NOT SPECIFIEDqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age65Unit of Onset AgeyearsWeight61.29SexFemale

Reaction

1)

reactionmeddraversionpt18.1ReactionExercise tolerance decreasedOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt18.1ReactionDyspnoeaOutcomeUnknown

3)

reactionmeddraversionpt18.1ReactionHeadacheOutcomeUnknown

4)

reactionmeddraversionpt18.1ReactionSubarachnoid haemorrhageOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt18.1ReactionAstheniaOutcomeNot recovered/not resolved

6)

reactionmeddraversionpt18.1ReactionIntracranial aneurysmOutcomeUnknown

7)

reactionmeddraversionpt18.1ReactionAcute myocardial infarctionOutcomeNot recovered/not resolved

8)

reactionmeddraversionpt18.1ReactionMobility decreasedOutcomeNot recovered/not resolved

9)

reactionmeddraversionpt18.1ReactionHypotensionOutcomeRecovered/resolved

10)

reactionmeddraversionpt18.1ReactionLoss of consciousnessOutcomeRecovered/resolved

11)

reactionmeddraversionpt18.1ReactionAcute respiratory failureOutcomeUnknown

12)

reactionmeddraversionpt18.1ReactionHypoxiaOutcomeUnknown

13)

reactionmeddraversionpt18.1ReactionAstheniaOutcomeNot recovered/not resolved

14)

reactionmeddraversionpt18.1ReactionStress cardiomyopathyOutcomeUnknown

15)

reactionmeddraversionpt18.1ReactionCardiac failure congestiveOutcomeUnknown

16)

reactionmeddraversionpt18.1ReactionRheumatoid arthritisOutcomeNot recovered/not resolved

17)

reactionmeddraversionpt18.1ReactionRespiratory disorderOutcomeUnknown

18)

reactionmeddraversionpt18.1ReactionIntracranial aneurysmOutcomeRecovering/resolving

19)

reactionmeddraversionpt18.1ReactionFatigueOutcomeNot recovered/not resolved

20)

reactionmeddraversionpt18.1ReactionCardiomyopathyOutcomeUnknown

21)

reactionmeddraversionpt18.1ReactionBreath holdingOutcomeUnknown

22)

reactionmeddraversionpt18.1ReactionBreath sounds abnormalOutcomeUnknown

23)

reactionmeddraversionpt18.1ReactionSubarachnoid haemorrhageOutcomeUnknown

24)

reactionmeddraversionpt18.1ReactionCognitive disorderOutcomeNot recovered/not resolved

25)

reactionmeddraversionpt18.1ReactionCardiogenic shockOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumb1039182drugauthorizationnumb125057drugdosageformSOLUTION FOR INJECTION IN PRE-FILLED SYRINGEdrugadministrationroute058drugstartdateformat102drugstartdate12/11/2015actiondrug1drugrecurreadministration3

activesubstance

activesubstancenameADALIMUMAB

openFDA Info on Medication

Application NumberBLA125057Brand NameHUMIRAGeneric NameADALIMUMABManufacturersAbbVie Inc.product_ndc 0074-0067, 0074-3799, 0074-6347, 0074-4339, 0074-9374, 0074-0243, 0074-0554, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRXCUI 351290, 352334, 727703, 727705, 763564, 763565, 797544, 825169, 825170, 1551887, ... spl_id1b259c93-37f5-4845-92ff-224dacfe1d50spl_set_id608d4f0d-b19f-46d3-749a-7159aa5f933dPackage NDC 0074-3799-02, 0074-3799-71, 0074-3799-06, 0074-3799-03, 0074-6347-02, 0074-4339- ...

2)

drugcharacterization2medicinalproductLISINOPRIL.drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameLISINOPRIL

openFDA Info on Medication

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

3)

drugcharacterization2medicinalproductRESTASISdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameCYCLOSPORINE

openFDA Info on Medication

Application NumberNDA050790Brand NameRESTASISGeneric NameCYCLOSPORINEManufacturersAllergan, Inc.product_ndc0023-9163Product TypeHUMAN PRESCRIPTION DRUGRouteOPHTHALMICActive IngredientsCYCLOSPORINERXCUI2572292, 2572293spl_id554c342b-15e5-4910-938f-d1c38ff0e516spl_set_id8e24af2b-bc1c-4849-94f2-6df950cdca89Package NDC0023-9163-12, 0023-9163-30, 0023-9163-60NUIN0000175457, N0000175458, N0000182141, N0000185503Established Pharmacologic ClassCalcineurin Inhibitor Immunosuppressant [EPC]Mechanism of Action Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprote ... UNII83HN0GTJ6D

4)

drugcharacterization2medicinalproductTYLENOLdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameACETAMINOPHEN

openFDA Info on Medication

Application Numberpart341, part343Brand Name TYLENOL COLD PLUS HEAD CONGESTION SEVERE, TYLENOL REGULAR STRENGTH, TYLENOL EXTR ... Generic NameACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHENManufacturersJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Divisionproduct_ndc 50580-566, 50580-495, 50580-458, 50580-487, 50580-496, 50580-451, 50580-600, 505 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDERXCUI1243679, 209387, 313782, 198436, 1738139, 198440, 209459spl_id da433eb1-9a1d-276e-e053-2a95a90a7794, dfd72ee1-40ac-6983-e053-2995a90a4d94, da40 ... spl_set_id ce43e5c2-fe96-4462-882c-d7479318b33d, de5c6654-56c5-40d3-a286-f04ed47ac7c8, 01f4 ... Package NDC 50580-566-25, 50580-495-01, 50580-458-11, 50580-458-50, 50580-458-10, 50580-487- ... NUIN0000193956, N0000008867, N0000009560Established Pharmacologic ClassExpectorant [EPC]Physiologic/Pharmacodynamic Effect Decreased Respiratory Secretion Viscosity [PE], Increased Respiratory Secretions ... UNII362O9ITL9D, 495W7451VQ, 04JA59TNSJ

5)

drugcharacterization2medicinalproductBENZOCAINE W/MENTHOLdrugdosagetextBENZOCAINE 15 MG WITH MENTHOL 3.6 MGdrugdosageformLOZENGEdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

6)

drugcharacterization2medicinalproductATORVASTATINdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameATORVASTATIN

openFDA Info on Medication

7)

drugcharacterization2medicinalproductCALCIUM CARBONATE.drugdosageformCHEWABLE TABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameCALCIUM CARBONATE

openFDA Info on Medication

Application Numberpart331Brand Name WINCO FOODS ANTACID ULTRA STRENGTH, ASSORTED FRUIT ANTACID FLAVOR CHEWS, ANTACID ... Generic NameCALCIUM CARBONATEManufacturers WINCO FOODS, LLC, Meijer Distribution Inc., Meijer, Unifirst First Aid Corporati ... product_ndc 67091-358, 41250-108, 41250-135, 47682-088, 47682-089, 47682-092, 30142-300, 825 ... Product TypeHUMAN OTC DRUGRouteORAL, TOPICALActive IngredientsCALCIUM CARBONATE, DIMETHICONERXCUI 308892, 308915, 1492387, 313884, 1432465, 308907, 308906, 1538595, 1044532, 3088 ... spl_id abaf7a85-739d-4b26-bd2c-ab0203a5002e, cf6f4563-972f-1341-e053-2995a90aec27, cf6f ... spl_set_id 1858cf76-cf36-4c56-9e15-14db609aa10f, 3ce0c1cd-32dc-4f78-e054-00144ff88e88, 4c6c ... Package NDC 67091-358-72, 41250-108-60, 41250-135-54, 47682-088-69, 47682-088-64, 47682-088- ... UNIIH0G9379FGK, 92RU3N3Y1ONUIN0000010282Physiologic/Pharmacodynamic EffectSkin Barrier Activity [PE]

8)

drugcharacterization2medicinalproductSENNOSIDES A+BdrugdosagetextSENNOSIDES 8.6 MG WITH DOCUSATE 50 MG 2 TABdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameSENNOSIDES A AND B

9)

drugcharacterization2medicinalproductHEPARINdrugdosagetext5000 UNITS INJECTIONSdrugdosageformCHEWABLE TABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameHEPARIN SODIUM

10)

drugcharacterization2medicinalproductMAGNESIUM OXIDE.drugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameMAGNESIUM OXIDE

openFDA Info on Medication

Application Numberpart331Brand NameMAGNESIUM OXIDE, ANTACIDGeneric NameMAGNESIUM OXIDEManufacturers Westminster Pharmaceuticals, LLC, PAR Pharmaceuticals, Marlex Pharmaceuticals In ... product_ndc 69367-298, 0603-0209, 10135-721, 58657-120, 54738-973, 68210-4171, 0603-0213, 54 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsMAGNESIUM OXIDERXCUI198741, 311430spl_id 5501dfcf-df9c-4b51-9722-b7e78076cd6f, 6dae00c5-fb60-4bb5-b278-d38ff3d1068c, dde2 ... spl_set_id 52eeac0e-94bb-48c3-81dc-578e96406c01, d3c5b01b-f0d6-4503-ab18-b1a72386e2c6, dc57 ... Package NDC 69367-298-20, 0603-0209-22, 10135-721-01, 58657-120-12, 54738-973-12, 68210-4171 ... UNII3A3U0GI71G

11)

drugcharacterization2medicinalproductOXYBUTYNINdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameOXYBUTYNIN

openFDA Info on Medication

Application NumberANDA202332, NDA021351, NDA202211Brand NameOXYBUTYNIN, OXYTROL, OXYTROL FOR WOMENGeneric NameOXYBUTYNINManufacturersZydus Pharmaceuticals (USA) Inc., Cadila Healthcare Limited, Allergan, Inc.product_ndc 68382-255, 68382-256, 68382-257, 70771-1086, 70771-1087, 70771-1088, 0023-6153, ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteORAL, TRANSDERMALActive IngredientsOXYBUTYNIN CHLORIDE, OXYBUTYNINRXCUI863619, 863628, 863636, 403799, 404448spl_id f8631e88-7755-4b29-848c-7ef657463803, 38ac4e71-8edf-4dd1-ba35-8e84006d4b48, 07d7 ... spl_set_id c042bf06-79a3-4dc7-ae05-3ef3cfae9d44, f405a774-bd91-4513-b7c7-c44f0596d988, 20de ... Package NDC 68382-255-06, 68382-255-14, 68382-255-16, 68382-255-01, 68382-255-05, 68382-255- ... UNIIL9F3D9RENQ, K9P6MC7092NUIN0000175700, N0000000125Established Pharmacologic ClassCholinergic Muscarinic Antagonist [EPC]Mechanism of ActionCholinergic Muscarinic Antagonists [MoA]

12)

drugcharacterization2medicinalproductPANTOPRAZOLEdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenamePANTOPRAZOLE SODIUM

openFDA Info on Medication

Application NumberANDA202882, ANDA205119, ANDA077619Brand NamePANTOPRAZOLE SODIUM, PANTOPRAZOLEGeneric NamePANTOPRAZOLEManufacturers XLCare Pharmaceuticals Inc., Quallent Pharmaceuticals Health LLC, Amneal Pharmac ... product_ndc 72865-229, 72865-230, 82009-010, 82009-011, 65162-636, 65162-637, 31722-712, 317 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPANTOPRAZOLE SODIUMspl_id e208ce17-1419-981f-e053-2a95a90a01da, e0dfa5fc-8721-2083-e053-2a95a90a8392, e1e7 ... spl_set_id 17468dbf-84b6-4c53-9ad5-341350d2cfab, 643eb498-d916-4fb7-9281-32895575ab36, f3de ... Package NDC 72865-229-90, 72865-230-90, 72865-230-10, 82009-010-90, 82009-011-90, 82009-011- ... UNII6871619Q5XRXCUI251872, 314200

13)

drugcharacterization2medicinalproductLUNESTAdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

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

14)

drugcharacterization2medicinalproductACETAMINOPHEN.drugindicationPRODUCT USED FOR UNKNOWN INDICATION

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, d0629d2a-8967-26fa-e053-2995a90a9f90, 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], ...

15)

drugcharacterization2medicinalproductALBUTEROL W/IPRATROPIUMdrugdosageformNEBULISER SOLUTIONdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameALBUTEROL\IPRATROPIUM

16)

drugcharacterization2medicinalproductONDANSETRONdrugdosagetextNONCHEMOdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameONDANSETRON

openFDA Info on Medication

Application Number ANDA206846, ANDA079224, ANDA090648, ANDA078776, ANDA077851, ANDA076972, ANDA0769 ... Brand NameONDANSETRON, ZUPLENZ, ONDANSETRON HYDROCHLORIDEGeneric NameONDANSETRON, ONDANSETRON HYDROCHLORIDE, ONDANSETRON TABLETSManufacturers Accord Healthcare, Inc., Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceutical ... product_ndc 16729-298, 23155-547, 23155-549, 16714-671, 71930-017, 71930-018, 45963-538, 459 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsONDANSETRON, ONDANSETRON HYDROCHLORIDERXCUI 283504, 1740467, 312085, 198052, 312086, 998028, 998032, 998033, 998035, 104894, ... spl_id d925044c-64a5-4a04-e053-2a95a90a8950, 49c66e0c-0444-4c88-942f-7d571aeedfd3, 6a07 ... spl_set_id 35e0d160-813f-41d7-a382-d2cab6485d9c, b746d4db-43e6-4219-9e6b-f53e59581305, ac3d ... Package NDC 16729-298-05, 23155-547-31, 23155-547-41, 23155-547-42, 23155-549-31, 16714-671- ... NUIN0000175817, N0000175818Mechanism of ActionSerotonin 3 Receptor Antagonists [MoA]Established Pharmacologic ClassSerotonin-3 Receptor Antagonist [EPC]UNII4AF302ESOS, NMH84OZK2B

17)

drugcharacterization2medicinalproductPOTASSIUM CHLORIDE.drugdosagetextPACKETdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenamePOTASSIUM CHLORIDE

openFDA Info on Medication

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

18)

drugcharacterization1medicinalproductHUMIRAdrugbatchnumb1039182drugauthorizationnumb125057drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition803drugdosageformSOLUTION FOR INJECTION IN PRE-FILLED SYRINGEdrugadministrationroute058drugindicationRHEUMATOID ARTHRITISdrugstartdateformat602drugstartdate//2005drugenddateformat610drugenddate/09/2015actiondrug1drugrecurreadministration3

activesubstance

activesubstancenameADALIMUMAB

openFDA Info on Medication

Application NumberBLA125057Brand NameHUMIRAGeneric NameADALIMUMABManufacturersAbbVie Inc.product_ndc 0074-0067, 0074-3799, 0074-6347, 0074-4339, 0074-9374, 0074-0243, 0074-0554, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRXCUI 351290, 352334, 727703, 727705, 763564, 763565, 797544, 825169, 825170, 1551887, ... spl_id1b259c93-37f5-4845-92ff-224dacfe1d50spl_set_id608d4f0d-b19f-46d3-749a-7159aa5f933dPackage NDC 0074-3799-02, 0074-3799-71, 0074-3799-06, 0074-3799-03, 0074-6347-02, 0074-4339- ...

19)

drugcharacterization2medicinalproductMETHOTREXATEdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameMETHOTREXATE

openFDA Info on Medication

Application Number NDA011719, ANDA040385, ANDA040263, ANDA209787, ANDA040632, ANDA201749, ANDA08123 ... Brand NameMETHOTREXATE, TREXALL, RASUVO, XATMEP, REDITREX, OTREXUPGeneric NameMETHOTREXATE, METHOTREXATE SODIUMManufacturers Hospira, Inc., Teva Women's Health, Inc., Fresenius Kabi USA, LLC, Alvogen Inc., ... product_ndc 61703-350, 61703-408, 51285-366, 51285-367, 51285-368, 51285-369, 63323-123, 477 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INTRATHECAL, ORAL, INTRA-ARTERIALActive IngredientsMETHOTREXATE SODIUM, METHOTREXATERXCUI 1655956, 1946772, 105586, 283510, 283511, 283671, 284592, 284593, 284594, 284595 ... spl_id e7f451fd-9103-459a-8a81-115f1fc1077c, 17840925-09d5-493f-90ba-f2082d625a86, d2bf ... spl_set_id 0d63ba29-b692-41b4-87e8-351265c8273f, 0e30eaef-5a09-4104-8a11-c32933eadeab, e942 ... Package NDC 61703-350-37, 61703-350-38, 61703-408-41, 61703-350-09, 61703-350-10, 61703-408- ... UNII3IG1E710ZN, YL5FZ2Y5U1NUIN0000175584, N0000000111Established Pharmacologic ClassFolate Analog Metabolic Inhibitor [EPC]Mechanism of ActionFolic Acid Metabolism Inhibitors [MoA]

20)

drugcharacterization2medicinalproductFOLIC ACID.drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameFOLIC ACID

openFDA Info on Medication

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

21)

drugcharacterization2medicinalproductFERROUS SULFATEdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameFERROUS SULFATE\FERROUS SULFATE, DRIED

openFDA Info on Medication

Brand NameFERROUS SULFATE, FERRUM SULPHURICUMGeneric NameFERROUS SULFATEManufacturersRichmond Pharmaceuticals, Inc., Boiron, Richmond Pharmaceuticals Inc.product_ndc54738-963, 0220-2111Product TypeHUMAN OTC DRUGRouteORALActive IngredientsFERROUS SULFATERXCUI310325spl_id 9a63ba0a-0ded-744b-e053-2a95a90a9344, 8723d1f8-ed45-3373-e053-2991aa0a81d7, 9a63 ... spl_set_id 58dd4f30-980b-44bc-9f8e-8d4626854b91, 7a4087d8-d054-bbdc-e053-2991aa0ae8cf, 5514 ... Package NDC54738-963-01, 54738-963-03, 0220-2111-41, 54738-963-13UNII39R4TAN1VT

summary

narrativeincludeclinicalCASE EVENT DATE: 201509