Adverse Event Report

Report

Version of Safety Report ID3Safety Report ID12528454primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate17/04/2019reporttype1serious1seriousnesshospitalization1seriousnessother1receivedateformat102Date Received05/07/2016receiptdateformat102Date Last Updated31/01/2019fulfillexpeditecriteria2companynumbUS-DSJP-DSU-2016-110864duplicate1

Report Duplicate

duplicatesourceDAIICHIduplicatenumbUS-DSJP-DSU-2016-110864

Primary Source

reportercountryUSqualification4

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age52Unit of Onset AgeyearsWeight129SexFemale

Reaction

1)

reactionmeddraversionpt21.1ReactionGastroenteritis viralOutcomeUnknown

2)

reactionmeddraversionpt21.1ReactionGastritis viralOutcomeRecovering/resolving

3)

reactionmeddraversionpt21.1ReactionHaematocheziaOutcomeUnknown

4)

reactionmeddraversionpt21.1ReactionHaemorrhoidsOutcomeUnknown

5)

reactionmeddraversionpt21.1ReactionInfectious colitisOutcomeUnknown

6)

reactionmeddraversionpt21.1ReactionDiverticulum intestinalOutcomeUnknown

7)

reactionmeddraversionpt21.1ReactionHiatus herniaOutcomeUnknown

8)

reactionmeddraversionpt21.1ReactionPeptic ulcerOutcomeUnknown

9)

reactionmeddraversionpt21.1ReactionAcute kidney injuryOutcomeRecovering/resolving

10)

reactionmeddraversionpt21.1ReactionSprue-like enteropathyOutcomeRecovering/resolving

Drug

1)

drugcharacterization2medicinalproductPROZACdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext20 MG, QDdrugdosageformCAPSULEdrugadministrationroute048drugindicationDEPRESSION

activesubstance

activesubstancenameFLUOXETINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA018936Brand NamePROZACGeneric NameFLUOXETINE HYDROCHLORIDEManufacturersDista Products Companyproduct_ndc0777-3104, 0777-3105, 0777-3107Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFLUOXETINE HYDROCHLORIDERXCUI104849, 205535, 261287, 310384, 310385, 313989spl_ida99ea01f-e367-47b8-b25c-8f554314c534spl_set_idc88f33ed-6dfb-4c5e-bc01-d8e36dd97299Package NDC0777-3104-02, 0777-3105-02, 0777-3105-30, 0777-3107-30UNIII9W7N6B1KJ

2)

drugcharacterization2medicinalproductPROZACdrugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40 MG, QDdrugdosageformCAPSULE

activesubstance

activesubstancenameFLUOXETINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA018936Brand NamePROZACGeneric NameFLUOXETINE HYDROCHLORIDEManufacturersDista Products Companyproduct_ndc0777-3104, 0777-3105, 0777-3107Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFLUOXETINE HYDROCHLORIDERXCUI104849, 205535, 261287, 310384, 310385, 313989spl_ida99ea01f-e367-47b8-b25c-8f554314c534spl_set_idc88f33ed-6dfb-4c5e-bc01-d8e36dd97299Package NDC0777-3104-02, 0777-3105-02, 0777-3105-30, 0777-3107-30UNIII9W7N6B1KJ

3)

drugcharacterization1medicinalproductBENICAR HCTdrugauthorizationnumb021532drugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext20/12.5MG, QDdrugdosageformFILM-COATED TABLETdrugadministrationroute048drugstartdateformat102drugstartdate01/03/2011actiondrug1drugadditional1

activesubstance

activesubstancenameHYDROCHLOROTHIAZIDE\OLMESARTAN MEDOXOMIL

openFDA Info on Medication

Application NumberNDA021532Brand NameBENICAR HCTGeneric NameOLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDEManufacturersDaiichi Sankyo, Inc., Cosette Pharmaceuticals, Inc.product_ndc65597-105, 65597-106, 65597-107, 0713-0863, 0713-0864, 0713-0865Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMILRXCUI403853, 403854, 403855, 847042, 847055, 847060spl_id95b56527-9a72-45dd-a7a5-378d72a1aba7, e1e5a69e-0535-9139-e053-2995a90a3dffspl_set_id6bbc032a-3cc4-4b1d-8124-1784214a2821, 881a1c32-c209-4038-9c5e-c5e46c6e0546Package NDC 65597-105-07, 65597-105-11, 65597-105-30, 65597-105-90, 65597-106-07, 65597-106- ... NUIN0000175359, N0000175419, M0471776Physiologic/Pharmacodynamic EffectIncreased Diuresis [PE]Established Pharmacologic ClassThiazide Diuretic [EPC]Chemical StructureThiazides [CS]UNII6M97XTV3HD, 0J48LPH2TH

4)

drugcharacterization2medicinalproductLOPRESSORdrugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext50 MG 1/2 TABLET, BIDdrugdosageformTABLETdrugadministrationroute048drugindicationHYPERTENSION

activesubstance

activesubstancenameMETOPROLOL TARTRATE

openFDA Info on Medication

Application NumberNDA017963Brand NameLOPRESSORGeneric NameMETOPROLOL TARTRATEManufacturersValidus Pharmaceuticals LLCproduct_ndc30698-458, 30698-459Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETOPROLOL TARTRATERXCUI866511, 866513, 866514, 866516spl_id0ed7956e-dc30-4330-805e-80ff7f3d6012spl_set_id0283bc9d-6998-493a-824a-d4c85f704111Package NDC30698-458-01, 30698-459-01UNIIW5S57Y3A5L

5)

drugcharacterization2medicinalproductLORTABdrugstructuredosagenumb1drugstructuredosageunit032drugdosagetext7.5/500 MG, PRNdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameACETAMINOPHEN\HYDROCODONE BITARTRATE

openFDA Info on Medication

Application NumberANDA040881Brand NameLORTABGeneric NameHYDROCODONE BITARTRATE AND ACETAMINOPHENManufacturersAkornproduct_ndc17478-450Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsACETAMINOPHEN, HYDROCODONE BITARTRATERXCUI1044427, 1442445spl_id912e747f-d400-4690-bf7a-d541f6ea6254spl_set_id21def91d-b6e3-4dde-983c-6925aedf0df0Package NDC17478-450-16UNII362O9ITL9D, NO70W886KK

6)

drugcharacterization2medicinalproductDONNATALdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameATROPINE SULFATE\HYOSCYAMINE SULFATE\PHENOBARBITAL\SCOPOLAMINE HYDROBROMIDE

openFDA Info on Medication

Brand NameDONNATALGeneric NamePHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDEManufacturersConcordia Pharmaceuticals Inc.product_ndc59212-422, 59212-423, 59212-425Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATROPINE SULFATE, HYOSCYAMINE SULFATE, PHENOBARBITAL, SCOPOLAMINE HYDROBROMIDERXCUI1046787, 1046924, 1046815, 1046978spl_id2ba33ecf-4093-4d77-8d2d-2b1268794607, 168515f9-39ac-4726-8e52-5f20c8c0d090spl_set_id4dba30db-7979-455f-a225-24f0a04d744e, c93cccdc-2f92-4cb3-9d14-06acdd51d94cPackage NDC 59212-423-04, 59212-423-16, 59212-423-10, 59212-422-04, 59212-422-16, 59212-422- ... UNII451IFR0GXB, 03J5ZE7KA5, YQE403BP4D, F2R8V82B84

7)

drugcharacterization2medicinalproductTRAZODONEdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameTRAZODONE HYDROCHLORIDE

openFDA Info on Medication

8)

drugcharacterization2medicinalproductLASIXdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

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

9)

drugcharacterization2medicinalproductPRILOSECdrugstructuredosagenumb30drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext30 MG, BIDdrugindicationGASTROOESOPHAGEAL REFLUX DISEASE

activesubstance

activesubstancenameOMEPRAZOLE MAGNESIUM

openFDA Info on Medication

Application NumberNDA022056Brand NamePRILOSECGeneric NameOMEPRAZOLE MAGNESIUMManufacturersCovis Pharma US, Incproduct_ndc70515-610, 70515-625Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE MAGNESIUMRXCUI797058, 797061, 797063, 797065spl_idba93d1bb-75ca-407c-b2e0-9aa66d8eed84spl_set_idb6761f84-53ac-4745-a8c8-1e5427d7e179Package NDC70515-625-01, 70515-610-01UNII426QFE7XLK

10)

drugcharacterization2medicinalproductMOTRINdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameIBUPROFEN

openFDA Info on Medication

Application NumberNDA020603, ANDA079113Brand NameMOTRIN INFANTS, MOTRIN PMGeneric NameIBUPROFEN, IBUPROFEN AND DIPHENHYDRAMINE CITRATEManufacturersJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Divisionproduct_ndc50580-198, 50580-563Product TypeHUMAN OTC DRUGRouteORALActive IngredientsIBUPROFEN, DIPHENHYDRAMINE CITRATERXCUI204442, 854762, 895664, 895666spl_iddb6d94a1-21f2-3c69-e053-2995a90a9ee5, d189154b-2808-ac7a-e053-2995a90af834spl_set_idc57f6ded-c0bd-45ae-823a-4c02ce334d98, 55403f19-58ae-450b-8a7b-0bc544088f20Package NDC 50580-198-50, 50580-198-51, 50580-198-52, 50580-563-20, 50580-563-40, 50580-563- ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIWK2XYI10QM, 4OD433S209

11)

drugcharacterization2medicinalproductMOBICdrugstructuredosagenumb15drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext15 MG, QDdrugdosageformTABLETdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameMELOXICAM

openFDA Info on Medication

Application NumberNDA020938Brand NameMOBICGeneric NameMELOXICAMManufacturersBoehringer Ingelheim Pharmaceuticals, Inc.product_ndc0597-0029, 0597-0030Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMELOXICAMRXCUI152695, 152697, 152698, 311486spl_id431b4e0b-6cf0-46b0-a2b9-27ef46803500spl_set_id676e73fb-51d2-449a-8749-1a7bcc257b11Package NDC0597-0029-01, 0597-0029-94, 0597-0030-01, 0597-0030-56NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIVG2QF83CGL

12)

drugcharacterization2medicinalproductPHENERGANdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenamePROMETHAZINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA083312Brand NamePHENERGANGeneric NamePROMETHAZINE HYDROCHLORIDEManufacturersWest-Ward Pharmaceuticals Corp., Hikma Pharmaceuticals USA Inc.product_ndc0641-6082, 0641-6083, 0641-6084, 0641-6085Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUSActive IngredientsPROMETHAZINE HYDROCHLORIDERXCUI992460, 992462, 992858, 992876spl_ided9c544d-8e03-45cb-8509-b71b630d764d, 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- ... UNIIR61ZEH7I1I

13)

drugcharacterization2medicinalproductLUNESTAdrugdosagetextUNKdrugindicationPRODUCT 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)

drugcharacterization2medicinalproductMETFORMINdrugstructuredosagenumb1000drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1000 MG, BIDdrugdosageformTABLETdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameMETFORMIN HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA200690, ANDA209674, ANDA209313Brand NameMETFORMIN HYDROCHLORIDE, METFORMINGeneric NameMETFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MGManufacturers Mylan Pharmaceuticals Inc., Ingenus Pharmaceuticals, LLC, Granules Pharmaceutica ... product_ndc0378-6001, 0378-6002, 50742-633, 50742-634, 70010-491, 70010-492Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETFORMIN HYDROCHLORIDERXCUI1807894, 1807917, 860975, 860981spl_id b1d71739-26c3-43d3-9088-60bef3689e74, d7e2ad60-7a17-4c65-b836-e56644be754d, d164 ... spl_set_id 7e41818c-60e9-4bcf-9586-7bb8d33d5e89, 49a0b5c2-ebaf-4c4c-905f-dfd1962ac647, 6d6e ... Package NDC 0378-6002-91, 0378-6001-91, 50742-633-60, 50742-633-90, 50742-633-10, 50742-634- ... UNII786Z46389E

15)

drugcharacterization2medicinalproductNEURONTINdrugstructuredosagenumb600drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext600 MG, BIDdrugdosageformTABLETdrugadministrationroute048drugindicationNEURALGIA

activesubstance

activesubstancenameGABAPENTIN

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_id6db0f340-6839-4488-8653-677baad5820bspl_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

16)

drugcharacterization1medicinalproductBENICARdrugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext20 MG, QDdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug1drugadditional1

activesubstance

activesubstancenameOLMESARTAN MEDOXOMIL

openFDA Info on Medication

Application NumberNDA021286Brand NameBENICARGeneric NameOLMESARTAN MEDOXOMILManufacturersCosette Pharmaceuticals, Inc., Daiichi Sankyo, Inc.product_ndc0713-0860, 0713-0861, 0713-0862, 65597-101, 65597-103, 65597-104Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOLMESARTAN MEDOXOMILspl_ide1e58027-cc06-6f64-e053-2995a90a9309, 9a1acd82-0655-4e72-9177-12ddf31c4b1bspl_set_id5b6f8a18-8f8a-4521-81c3-3a39c73c6646, 33770d80-754f-11de-8dba-0002a5d5c51bPackage NDC 0713-0860-30, 0713-0861-30, 0713-0862-30, 65597-101-30, 65597-103-03, 65597-103- ... UNII6M97XTV3HDRXCUI349373, 349401, 349405, 352199, 352200, 352201

17)

drugcharacterization1medicinalproductBENICAR HCTdrugauthorizationnumb021532drugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40/12.5MG, UNKdrugdosageformFILM-COATED TABLETdrugadministrationroute048drugindicationHYPERTENSIONdrugstartdateformat102drugstartdate18/05/2004drugenddateformat602drugenddate//2016actiondrug1drugadditional1

activesubstance

activesubstancenameHYDROCHLOROTHIAZIDE\OLMESARTAN MEDOXOMIL

openFDA Info on Medication

Application NumberNDA021532Brand NameBENICAR HCTGeneric NameOLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDEManufacturersDaiichi Sankyo, Inc., Cosette Pharmaceuticals, Inc.product_ndc65597-105, 65597-106, 65597-107, 0713-0863, 0713-0864, 0713-0865Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMILRXCUI403853, 403854, 403855, 847042, 847055, 847060spl_id95b56527-9a72-45dd-a7a5-378d72a1aba7, e1e5a69e-0535-9139-e053-2995a90a3dffspl_set_id6bbc032a-3cc4-4b1d-8124-1784214a2821, 881a1c32-c209-4038-9c5e-c5e46c6e0546Package NDC 65597-105-07, 65597-105-11, 65597-105-30, 65597-105-90, 65597-106-07, 65597-106- ... NUIN0000175359, N0000175419, M0471776Physiologic/Pharmacodynamic EffectIncreased Diuresis [PE]Established Pharmacologic ClassThiazide Diuretic [EPC]Chemical StructureThiazides [CS]UNII6M97XTV3HD, 0J48LPH2TH

18)

drugcharacterization2medicinalproductLYRICAdrugstructuredosagenumb75drugstructuredosageunit003drugdosagetext75 MG, UNKdrugdosageformCAPSULEdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenamePREGABALIN

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, bfdec19d-6a54-449c-95b4-908d28e5369aspl_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

19)

drugcharacterization2medicinalproductASPRINdrugstructuredosagenumb325drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext325 MG, QDdrugdosageformTABLETdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameASPIRIN

20)

drugcharacterization2medicinalproductLIPITORdrugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext40 MG, QDdrugdosageformTABLETdrugadministrationroute048drugindicationHYPERLIPIDAEMIA

activesubstance

activesubstancenameATORVASTATIN CALCIUM

openFDA Info on Medication

Application NumberNDA020702Brand NameLIPITORGeneric NameATORVASTATIN CALCIUMManufacturersParke-Davis Div of Pfizer Incproduct_ndc0071-0155, 0071-0156, 0071-0157, 0071-0158Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATORVASTATIN CALCIUM TRIHYDRATERXCUI259255, 262095, 617310, 617311, 617312, 617314, 617318, 617320spl_idb95993d7-bc87-4d0a-9926-e3d36c5b3b4espl_set_idc6e131fe-e7df-4876-83f7-9156fc4e8228Package NDC 0071-0155-23, 0071-0155-40, 0071-0155-97, 0071-0156-23, 0071-0156-40, 0071-0156- ... UNII48A5M73Z4Q

21)

drugcharacterization2medicinalproductKCLdrugstructuredosagenumb10drugstructuredosageunit029drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MEQ, BIDdrugdosageformTABLETdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenamePOTASSIUM CHLORIDE

summary

narrativeincludeclinicalCASE EVENT DATE: 20050425