Adverse Event Report

Report

Version of Safety Report ID3Safety Report ID10764060primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate08/05/2018reporttype1serious2receivedateformat102Date Received04/02/2015receiptdateformat102Date Last Updated30/01/2018fulfillexpeditecriteria2companynumbUS-ACORDA-ACO_101894_2014duplicate1

Report Duplicate

duplicatesourceACORDAduplicatenumbUS-ACORDA-ACO_101894_2014

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Weight85.71SexFemale

Reaction

1)

reactionmeddraversionpt21.0ReactionDysstasiaOutcomeUnknown

2)

reactionmeddraversionpt21.0ReactionCystitisOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt21.0ReactionUrinary tract infectionOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt21.0ReactionBalance disorderOutcomeUnknown

5)

reactionmeddraversionpt21.0ReactionGait disturbanceOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductMETOPROLOL ERdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameMETOPROLOL SUCCINATE

2)

drugcharacterization2medicinalproductFLUOXETINEdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameFLUOXETINE HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA090223, ANDA209695, ANDA078619, ANDA079209, ANDA210935, ANDA211282, ANDA0754 ... Brand NameFLUOXETINEGeneric NameFLUOXETINE, FLUOXETINE HYDROCHLORIDEManufacturers Alembic Pharmaceuticals Limited, Nivagen Pharmaceuticals, Inc., BluePoint Labora ... product_ndc 46708-271, 46708-272, 46708-273, 75834-148, 68001-399, 68001-400, 68001-401, 658 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFLUOXETINE HYDROCHLORIDERXCUI310384, 310385, 313989, 1190110, 310386, 248642, 313990, 2532159, 2532163spl_id 40ef6547-f80f-45f4-8719-ebc913b4df7d, 789b1507-b5c0-4a50-bf82-f1fe9bb3c8d6, d290 ... spl_set_id 6b9c2d73-866b-44c4-8718-e7e4a9a0fb55, f4cbf9a9-1d7f-4aa0-a18d-fba50d49bd2b, f89a ... Package NDC 46708-271-30, 46708-271-31, 46708-271-71, 46708-271-91, 46708-272-30, 46708-272- ... UNIII9W7N6B1KJ

3)

drugcharacterization2medicinalproductASPIRIN.drugstructuredosagenumb81drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext81 MG, QDdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameASPIRIN

openFDA Info on Medication

Application Numberpart343, NDA203697Brand Name ASPIRIN ADULT LOW DOSE, BAYER GENUINE ASPIRIN, ZEE ASPIRIN, ENTERIC COATED ASPIR ... Generic NameASPIRIN, ASPIRIN 81 MG, ASPIRIN TABLET 325MG, ASPIRIN 325 MGManufacturers Wal-Mart Stores Inc, Unifirst First Aid Corporation, Cintas Corporation, Strateg ... product_ndc 49035-914, 47682-456, 42961-044, 49348-937, 36800-545, 0363-0587, 70000-0218, 63 ... Product TypeHUMAN OTC DRUGRouteORAL, RECTALActive IngredientsASPIRIN, CALCIUM CARBONATERXCUI 308416, 211874, 212033, 198467, 318272, 1722689, 1722695, 260847, 198471, 825180 ... spl_id 70f66f99-a450-4ab6-a3b9-c5d9207e0a79, da59962f-0c77-5c08-e053-2a95a90aaee7, 1b00 ... spl_set_id 2826d84d-b135-4e20-aeea-271e9f74f431, 356e4ff4-a7f1-4a50-9b86-2555e232b300, 4c30 ... Package NDC 49035-914-32, 47682-456-50, 47682-456-47, 42961-044-01, 42961-044-02, 42961-044- ... NUIN0000000160, N0000008836, M0001335, N0000175722, N0000175578, N0000008832Mechanism of ActionCyclooxygenase Inhibitors [MoA]Physiologic/Pharmacodynamic EffectDecreased Prostaglandin Production [PE], Decreased Platelet Aggregation [PE]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]UNIIR16CO5Y76E, H0G9379FGK

4)

drugcharacterization2medicinalproductHYDROXYCHLOROQUINEdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameHYDROXYCHLOROQUINE

5)

drugcharacterization2medicinalproductCOPAXONEdrugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition803drugdosagetext40 MG, 3X/WKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameGLATIRAMER ACETATE

openFDA Info on Medication

Application NumberNDA020622Brand NameCOPAXONEGeneric NameGLATIRAMER ACETATEManufacturersTeva Neuroscience, Inc.product_ndc68546-317, 68546-325Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUSActive IngredientsGLATIRAMER ACETATERXCUI1111641, 1111642, 1487361, 1487363spl_id04f9ea25-0d45-4e44-8ed8-dc61db4f5466spl_set_idaa88f583-4f5f-433b-80b4-1f4c9fb28357Package NDC68546-317-00, 68546-317-30, 68546-325-06, 68546-325-12UNII5M691HL4BO

6)

drugcharacterization2medicinalproductLEFLUNOMIDE.drugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameLEFLUNOMIDE

openFDA Info on Medication

Application Number ANDA091369, ANDA211863, ANDA213652, ANDA077086, ANDA212308, ANDA212453, NDA02090 ... Brand NameLEFLUNOMIDE, ARAVAGeneric NameLEFLUNOMIDEManufacturers Alembic Pharmaceuticals Limited, Lupin Pharmaceuticals, Inc., Aurobindo Pharma L ... product_ndc 46708-436, 46708-437, 70748-129, 70748-130, 59651-348, 59651-349, 23155-043, 231 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLEFLUNOMIDERXCUI205284, 205285, 205286, 213377, 213379, 213380spl_id e61a8fad-d513-4d27-aba0-e1a55b49c164, 94bf71d8-81f1-4285-b2c0-364434bccc26, 379c ... spl_set_id f6a4107e-b393-45ed-8e5a-70af5bd53826, 5d48fded-b43b-461a-8488-ca1da5c41a03, c358 ... Package NDC 46708-436-30, 46708-436-60, 46708-436-31, 46708-436-71, 46708-437-30, 46708-437- ... NUIN0000175713Established Pharmacologic ClassAntirheumatic Agent [EPC]UNIIG162GK9U4W

7)

drugcharacterization2medicinalproductMODAFINIL.drugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameMODAFINIL

openFDA Info on Medication

Application Number ANDA202700, ANDA077667, ANDA202566, NDA020717, ANDA209966, ANDA078963, ANDA20719 ... Brand NameMODAFINIL, PROVIGILGeneric NameMODAFINILManufacturers Alembic Pharmaceuticals Limited, Apotex Corp., Alembic Pharmaceuticals Inc., Ris ... product_ndc 46708-385, 46708-386, 60505-2526, 60505-2527, 62332-385, 62332-386, 57237-154, 5 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMODAFINILRXCUI205324, 260218, 213471, 226426spl_id b7315903-20d7-4dce-80ea-3d33fa5f9f16, a2501635-6969-cca6-92c1-e6259d7d7708, 7aa2 ... spl_set_id 5b8496fe-b647-4ce6-aeef-71245712e46f, 944daf47-49a6-93ca-e348-4a0f1b6d937e, 41f9 ... Package NDC 46708-385-30, 46708-385-91, 46708-385-10, 46708-385-60, 46708-385-90, 46708-386- ... NUIN0000175729, N0000175651, N0000175769Physiologic/Pharmacodynamic EffectCentral Nervous System Stimulation [PE], Increased Sympathetic Activity [PE]Established Pharmacologic ClassSympathomimetic-like Agent [EPC]UNIIR3UK8X3U3D

8)

drugcharacterization2medicinalproductTROSPIUM ERdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

9)

drugcharacterization2medicinalproductCELEBREXdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameCELECOXIB

openFDA Info on Medication

Application NumberNDA020998Brand NameCELEBREXGeneric NameCELECOXIBManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc0025-1515, 0025-1520, 0025-1525, 0025-1530Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCELECOXIBRXCUI205322, 205323, 213468, 213469, 349514, 352314, 686379, 686381spl_idaa50b33d-5037-4cd8-968a-b0f64f8fb490spl_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

10)

drugcharacterization2medicinalproductBACLOFEN.drugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameBACLOFEN

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA209102, ANDA215885, ANDA209594, ANDA074584, ANDA2100 ... Brand NameBACLOFEN, BACLOFEN (INTRATHECAL), LYVISPAH, OZOBAX, FLEQSUVYGeneric NameBACLOFENManufacturers Northstar RxLLC, TruPharma LLC, Lifestar Pharma LLC, Mylan Institutional LLC, Up ... product_ndc 16714-071, 16714-072, 52817-319, 52817-320, 52817-321, 70756-085, 70756-288, 707 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 430902, 1300890, 308517, 1666613, 2586589, 2586595, 2586596, 258 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, b8da4a75-4c34-1d06-e053-2a95a90a7886, f4a6 ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 68aa591e-ea98-4438-9a4a-4f7e9ea2b285, f9dd ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 52817-319-10, 52817-320- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

11)

drugcharacterization1medicinalproductAMPYRAdrugbatchnumbVYDYdrugauthorizationnumb022250drugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MG, BIDdrugdosageformTABLETdrugadministrationroute048drugindicationMULTIPLE SCLEROSISdrugstartdateformat102drugstartdate17/03/2015actiondrug1drugadditional2

activesubstance

activesubstancenameDALFAMPRIDINE

openFDA Info on Medication

Application NumberNDA022250Brand NameAMPYRAGeneric NameDALFAMPRIDINEManufacturersAcorda Therapeutics, Inc.product_ndc10144-427Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDALFAMPRIDINERXCUI897021, 897025spl_idd17992b6-a426-7196-e053-2a95a90a8282spl_set_id550eb76a-e4a6-4fa1-ad65-c0fd8b0ce783Package NDC10144-427-60NUIN0000192795, N0000175448Established Pharmacologic ClassPotassium Channel Blocker [EPC]Mechanism of ActionPotassium Channel Antagonists [MoA]UNIIBH3B64OKL9

12)

drugcharacterization2medicinalproductSYSTANE (HYPROMELLOSE 2910 (4000 MPA.S))drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition805drugdosagetext3 DROPS EACH EYE EVERY HOURdrugadministrationroute047drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameHYPROMELLOSE 2910 (4000 MPA.S)

13)

drugcharacterization2medicinalproductNAMENDA XRdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameMEMANTINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA022525Brand NameNAMENDA XRGeneric NameMEMANTINE HYDROCHLORIDEManufacturersAllergan, Inc.product_ndc0456-3407, 0456-3414, 0456-3421, 0456-3428, 0456-3400Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMEMANTINE HYDROCHLORIDERXCUI996594, 996597, 996603, 996605, 996609, 996611, 996615, 996617, 996624, 996633spl_id3fae1fd7-ac36-4564-9de9-84533cea4636spl_set_id710f523f-0158-4639-8ce7-57598247d48cPackage NDC 0456-3407-33, 0456-3414-11, 0456-3414-63, 0456-3414-33, 0456-3414-90, 0456-3421- ... UNIIJY0WD0UA60

14)

drugcharacterization2medicinalproductALLOPURINOL.drugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameALLOPURINOL

openFDA Info on Medication

Application Number NDA020298, ANDA203154, ANDA212363, ANDA071450, ANDA204467, NDA018832, NDA018877, ... Brand NameALOPRIM, ALLOPURINOL, ZYLOPRIMGeneric NameALLOPURINOLManufacturers Mylan Institutional LLC, Accord Healthcare Inc., Gland Pharma Limited, Sun Pharm ... product_ndc 67457-978, 16729-134, 16729-135, 68083-380, 53489-156, 53489-157, 23155-693, 231 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsALLOPURINOL SODIUM, ALLOPURINOLRXCUI252931, 261265, 197319, 197320, 213995, 213998spl_id 2acff21e-7d8f-4b03-b7b7-9400f54f66ac, d10d00c1-a0d9-6fd8-e053-2a95a90a588a, 6a0e ... spl_set_id 018525b1-e37d-4ff2-9dc3-36b3d90ac3e0, 682dd8b8-fc6e-47c5-95b7-82d7ad96b750, 4839 ... Package NDC 67457-978-50, 16729-134-10, 16729-134-01, 16729-134-16, 16729-134-17, 16729-135- ... UNII428673RC2Z, 63CZ7GJN5INUIN0000175698, N0000000206Established Pharmacologic ClassXanthine Oxidase Inhibitor [EPC]Mechanism of ActionXanthine Oxidase Inhibitors [MoA]

15)

drugcharacterization1medicinalproductAMPYRAdrugbatchnumb14A240drugauthorizationnumb022250drugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MG UNKdrugdosageformTABLETdrugadministrationroute048drugindicationGAIT DISTURBANCEdrugenddateformat610drugenddate/10/2014actiondrug1drugadditional2

activesubstance

activesubstancenameDALFAMPRIDINE

openFDA Info on Medication

Application NumberNDA022250Brand NameAMPYRAGeneric NameDALFAMPRIDINEManufacturersAcorda Therapeutics, Inc.product_ndc10144-427Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDALFAMPRIDINERXCUI897021, 897025spl_idd17992b6-a426-7196-e053-2a95a90a8282spl_set_id550eb76a-e4a6-4fa1-ad65-c0fd8b0ce783Package NDC10144-427-60NUIN0000192795, N0000175448Established Pharmacologic ClassPotassium Channel Blocker [EPC]Mechanism of ActionPotassium Channel Antagonists [MoA]UNIIBH3B64OKL9

16)

drugcharacterization2medicinalproductMYRBETRIQdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameMIRABEGRON

openFDA Info on Medication

Application NumberNDA202611, NDA213801Brand NameMYRBETRIQGeneric NameMIRABEGRONManufacturersAstellas Pharma US, Inc.product_ndc0469-2601, 0469-2602, 0469-5020Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMIRABEGRONRXCUI1300791, 1300797, 1300801, 1300803, 2541233, 2541237spl_ida842ec61-d7fc-41f3-9c80-ec5f1cde8c3aspl_set_idba9e9e15-e666-4c56-9271-2e24739cfa2dPackage NDC 0469-2601-30, 0469-2601-90, 0469-2601-07, 0469-2602-30, 0469-2602-90, 0469-2602- ... NUIN0000185008, N0000185007, N0000182137, N0000190114, N0000185503Established Pharmacologic Classbeta3-Adrenergic Agonist [EPC]Mechanism of Action Adrenergic beta3-Agonists [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrom ... UNIIMVR3JL3B2V

17)

drugcharacterization2medicinalproductATORVASTATINdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameATORVASTATIN

openFDA Info on Medication

18)

drugcharacterization2medicinalproductESTRACEdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameESTRADIOL

openFDA Info on Medication

Application NumberANDA040197, ANDA086069Brand NameESTRACEGeneric NameESTRADIOLManufacturersAllergan, Inc.product_ndc0430-0720, 0430-0721, 0430-0722, 0430-3754Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, VAGINALActive IngredientsESTRADIOLRXCUI197657, 197658, 197659, 205909, 206101, 206241, 310169, 890918spl_id7d28252e-6605-4939-8d94-b2287d66fd98, ea442e5f-53d6-4dff-9a37-bc6c98dfefa9spl_set_ida3803ba3-4eee-4e2e-ac8c-821a4e6720cc, dfc41fcd-c5ba-4b25-b647-cf04d3988b3ePackage NDC0430-0720-24, 0430-0721-24, 0430-0722-24, 0430-3754-14NUIM0447348, N0000175825, N0000000100Chemical StructureEstradiol Congeners [CS]Established Pharmacologic ClassEstrogen [EPC]Mechanism of ActionEstrogen Receptor Agonists [MoA]UNII4TI98Z838E

19)

drugcharacterization2medicinalproductAUBAGIOdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameTERIFLUNOMIDE

openFDA Info on Medication

Application NumberNDA202992Brand NameAUBAGIOGeneric NameTERIFLUNOMIDEManufacturersGenzyme Corporationproduct_ndc58468-0210, 58468-0211Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTERIFLUNOMIDERXCUI1310525, 1310531, 1310533, 1310535spl_idb945dc1c-772e-48d8-94c1-f8b8b53cbcfdspl_set_id4650d12c-b9c8-4525-b07f-a2d773eca155Package NDC 58468-0211-1, 58468-0211-2, 58468-0211-4, 58468-0211-3, 58468-0210-2, 58468-0210 ... NUIN0000185502, N0000185501Established Pharmacologic ClassPyrimidine Synthesis Inhibitor [EPC]Mechanism of ActionDihydroorotate Dehydrogenase Inhibitors [MoA]UNII1C058IKG3B

20)

drugcharacterization2medicinalproductVITAMIN D3drugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameCHOLECALCIFEROL

openFDA Info on Medication

Application NumberANDA090455Brand NameVITAMIN DGeneric NameERGOCALCIFEROLManufacturers Strides Pharma Science Limited, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmac ... product_ndc64380-737, 23155-809Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERGOCALCIFEROLRXCUI1367410spl_id08a99dff-5765-49b0-b289-4e854d3c6725, 9c09c2d2-ef29-4654-be7d-ed3b2b508f43spl_set_id2c4c0a36-12cf-444d-9d57-de983eef4d36, 96da2c1e-6c5e-4df0-8166-3de53c08a701Package NDC64380-737-06, 64380-737-25, 23155-809-01NUIM0007651, N0000175909Chemical StructureErgocalciferols [CS]Established Pharmacologic ClassProvitamin D2 Compound [EPC]UNIIVS041H42XC

21)

drugcharacterization2medicinalproductLUNESTAdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

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

22)

drugcharacterization2medicinalproductAMLODIPINEdrugdosagetextUNKdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameAMLODIPINE BESYLATE

openFDA Info on Medication

Application NumberNDA214439, NDA211340Brand NameNORLIQVA, KATERZIAGeneric NameAMLODIPINEManufacturersCMP Pharma, Inc., Azurity Pharmaceuticals, Inc.product_ndc46287-035, 52652-5001Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMLODIPINE, AMLODIPINE BENZOATERXCUI2599173, 2599179, 2184120, 2184126spl_id63a6bb49-fb68-4351-be5f-a6b6e8f6b540, df623dda-e184-4011-8fce-4e729b2e6b2dspl_set_idc1730a51-4383-4c61-a9a1-7e1326bd0abe, df673a4d-acb8-444c-a472-c87ab8cbd366Package NDC46287-035-15, 52652-5001-1NUIN0000000069, N0000175421, N0000175566, M0006414, N0000190114Mechanism of ActionCalcium Channel Antagonists [MoA], Cytochrome P450 3A Inhibitors [MoA]Established Pharmacologic ClassDihydropyridine Calcium Channel Blocker [EPC], Calcium Channel Blocker [EPC]Chemical StructureDihydropyridines [CS]UNII1J444QC288, XD75TQ8A2P