Adverse Event Report

Report

Version of Safety Report ID3Safety Report ID10332869primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate25/11/2015reporttype1serious1seriousnessother1receivedateformat102Date Received22/07/2014receiptdateformat102Date Last Updated06/08/2015fulfillexpeditecriteria1companynumbPHHY2014US088797duplicate1

Report Duplicate

duplicatesourceSANDOZduplicatenumbPHHY2014US088797

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

SexFemale

Reaction

1)

reactionmeddraversionpt18.1ReactionPerformance status decreasedOutcomeRecovering/resolving

2)

reactionmeddraversionpt18.1ReactionMuscle spasmsOutcomeRecovering/resolving

3)

reactionmeddraversionpt18.1ReactionPainOutcomeRecovering/resolving

4)

reactionmeddraversionpt18.1ReactionFeeling drunkOutcomeRecovering/resolving

5)

reactionmeddraversionpt18.1ReactionNo therapeutic responseOutcomeRecovering/resolving

6)

reactionmeddraversionpt18.1ReactionBack painOutcomeRecovering/resolving

7)

reactionmeddraversionpt18.1ReactionSomnolenceOutcomeRecovering/resolving

Drug

1)

drugcharacterization1medicinalproductMETFORMINdrugauthorizationnumb75985drugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, BIDdrugadministrationroute048actiondrug5drugrecurreadministration3

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

2)

drugcharacterization1medicinalproductFENOFIBRATE.drugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, QDdrugdosageformCAPSULEdrugadministrationroute048actiondrug5drugrecurreadministration3

activesubstance

activesubstancenameFENOFIBRATE

openFDA Info on Medication

Application Number ANDA211080, ANDA209950, ANDA207378, ANDA211122, ANDA210606, ANDA090715, NDA02169 ... Brand NameFENOFIBRATE, FENOFIBRATE FILM COATED, ANTARA, TRICOR, LIPOFEN, FENOGLIDEGeneric NameFENOFIBRATEManufacturers Solco Healthcare US, LLC, Amneal Pharmaceuticals NY LLC, Northstar Rx LLC, Gravi ... product_ndc 43547-430, 43547-431, 69238-1262, 69238-1263, 16714-739, 16714-740, 16714-741, 6 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFENOFIBRATERXCUI 477560, 477562, 349287, 351133, 200311, 310288, 310289, 483425, 483427, 1442163, ... spl_id 165e6912-1ca0-4fad-8c3c-97a927d0d249, eabb010f-d348-4d41-afac-20c21ef60800, 502b ... spl_set_id 085109a6-f006-44f0-a170-980d8899a365, 7e79d495-5d59-485e-b3c2-7c31ba044948, e47b ... Package NDC 43547-430-09, 43547-430-50, 43547-431-09, 43547-431-50, 69238-1262-9, 69238-1263 ... NUIN0000175596, N0000175375, M0199111Established Pharmacologic ClassPeroxisome Proliferator Receptor alpha Agonist [EPC]Mechanism of ActionPeroxisome Proliferator-activated Receptor alpha Agonists [MoA]Chemical StructurePPAR alpha [CS]UNIIU202363UOS

3)

drugcharacterization1medicinalproductPOTASSIUMdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, QDdrugdosageformTABLETdrugadministrationroute048actiondrug5drugrecurreadministration3

activesubstance

activesubstancenamePOTASSIUM

4)

drugcharacterization1medicinalproductFLUOXETINEdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, QDdrugdosageformCAPSULEdrugadministrationroute048actiondrug5drugrecurreadministration3

activesubstance

activesubstancenameFLUOXETINE\FLUOXETINE 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

5)

drugcharacterization1medicinalproductLASIXdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, QDdrugdosageformTABLETdrugadministrationroute048actiondrug5drugrecurreadministration3

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

6)

drugcharacterization1medicinalproductEXCEDRINdrugdosagetextUNK UKN, PRNdrugadministrationroute048drugindicationMIGRAINEactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameACETAMINOPHEN\ASPIRIN\CAFFEINE

openFDA Info on Medication

Application Numberpart343, NDA020802Brand Name EXCEDRIN EXTRA STRENGTH GELTABS, EXCEDRIN MIGRAINE GELTABS, EXCEDRIN MIGRAINE, E ... Generic Name ACETAMINOPHEN, ASPRIN, CAFFEINE, ACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINE, AC ... Manufacturers GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, Jones Healthcare Group - ... product_ndc 0067-2021, 0067-2035, 67414-239, 0067-8203, 0067-8201, 0067-2039, 0067-2000, 006 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsACETAMINOPHEN, ASPIRIN, CAFFEINERXCUI209468, 308297, 307686, 404172spl_id 7cb14fb8-1195-4da3-b9d7-7375d26fa029, edbb64b9-f8ba-48db-8a36-d5837114f822, ddd2 ... spl_set_id 11a8439b-0159-4351-b0f5-fe7fad6a33c0, cc2f4a6f-2a27-4a60-b5ef-ae0bb0988ff8, c416 ... Package NDC 0067-2021-20, 0067-2021-24, 0067-2021-80, 0067-2035-20, 0067-2035-24, 0067-2035- ... 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], ... UNII362O9ITL9D, R16CO5Y76E, 3G6A5W338E

7)

drugcharacterization1medicinalproductBACLOFEN INTRATHECALdrugstructuredosagenumb24.944drugstructuredosageunit004drugdosagetext24.944 UG, PER DAYdrugdosageformAMPOULEdrugadministrationroute037drugindicationPAINdrugenddateformat102drugenddate09/07/2014actiondrug1drugrecurreadministration3

activesubstance

activesubstancenameBACLOFEN

openFDA Info on Medication

Application NumberANDA210048, ANDA091193Brand NameBACLOFEN (INTRATHECAL)Generic NameBACLOFENManufacturersMAlA Pharmaceuticals, Inc., Emerald International Limitedproduct_ndc70511-122, 70511-124, 71525-005, 71525-010, 71525-040Product TypeHUMAN PRESCRIPTION DRUGRouteINTRATHECALActive IngredientsBACLOFENRXCUI308517, 1666613, 308516spl_idc1aad0b3-4d62-4bf4-8d31-06a1aab94943, 66d85337-b4ad-403e-8631-3123311477b7spl_set_id11ba5575-a856-414a-89f8-17f3a01de55b, 63c13374-f4d1-4437-a703-acb8211f2ae4Package NDC 70511-122-10, 70511-124-10, 71525-010-20, 71525-010-01, 71525-040-20, 71525-040- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

8)

drugcharacterization1medicinalproductBACLOFEN.drugstructuredosagenumb1.5drugstructuredosageunit032drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MG TABLET 1.5 TID PRNdrugadministrationroute048actiondrug1drugrecurreadministration3

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

9)

drugcharacterization1medicinalproductLUNESTAdrugstructuredosagenumb1drugstructuredosageunit032drugdosagetext1 DF, QHSdrugdosageformTABLETdrugadministrationroute048actiondrug1drugrecurreadministration3

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

10)

drugcharacterization1medicinalproductXANAXdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, TIDdrugdosageformTABLETdrugadministrationroute048actiondrug5drugrecurreadministration3

activesubstance

activesubstancenameALPRAZOLAM

openFDA Info on Medication

Application NumberNDA021434, NDA018276Brand NameXANAX XR, XANAXGeneric NameALPRAZOLAMManufacturersPharmacia & Upjohn Company LLCproduct_ndc 0009-0057, 0009-0059, 0009-0066, 0009-0068, 0009-0094, 0009-0029, 0009-0055, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 433798, 433799, 433800, 433801, 687022, 687023, 687024, 687025, 141927, 141928, ... spl_idf364e489-b47b-4283-a7fe-d5b15f77447e, bf933d5a-53e2-4454-a040-cacc061bca92spl_set_idaa58fff3-c297-49be-838b-599c32ad9835, 388e249d-b9b6-44c3-9f8f-880eced0239fPackage NDC 0009-0057-07, 0009-0059-07, 0009-0066-07, 0009-0068-07, 0009-0029-01, 0009-0029- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

11)

drugcharacterization1medicinalproductDILAUDIDdrugstructuredosagenumb7.502drugstructuredosageunit003drugdosagetext7.502 MG, PER DAYdrugadministrationroute037actiondrug4

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

12)

drugcharacterization1medicinalproductMIRALAXdrugstructuredosagenumb1drugstructuredosageunit032drugdosagetext1 DF, PRNdrugadministrationroute048actiondrug5drugrecurreadministration3

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

13)

drugcharacterization1medicinalproductZETIAdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, QDdrugdosageformTABLETdrugadministrationroute048actiondrug5drugrecurreadministration3

activesubstance

activesubstancenameEZETIMIBE

openFDA Info on Medication

Application NumberNDA021445Brand NameZETIAGeneric NameEZETIMIBEManufacturersOrganon LLCproduct_ndc78206-178Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsEZETIMIBERXCUI349556, 352304spl_id51b443ef-2feb-4db4-9175-096539adbdecspl_set_id174e45e0-45bb-48b7-9e60-8f6cfc1d22bbPackage NDC78206-178-01NUIN0000008553, N0000175911Physiologic/Pharmacodynamic EffectDecreased Cholesterol Absorption [PE]Established Pharmacologic ClassDietary Cholesterol Absorption Inhibitor [EPC]UNIIEOR26LQQ24

14)

drugcharacterization1medicinalproductVISTARILdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, TIDdrugdosageformCAPSULEdrugadministrationroute048actiondrug5drugrecurreadministration3

activesubstance

activesubstancenameHYDROXYZINE PAMOATE

openFDA Info on Medication

Application NumberNDA011459Brand NameVISTARILGeneric NameHYDROXYZINE PAMOATEManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc0069-5410, 0069-5420, 0069-5440Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDROXYZINE PAMOATERXCUI995253, 995255, 995274, 995276, 995278, 995280spl_id2fb74df1-48cd-43c5-b99f-6967faf02da2spl_set_idc271f97f-040e-492b-9194-2c8b74675a95Package NDC0069-5410-66, 0069-5420-66, 0069-5440-93, 0069-5440-97UNIIM20215MUFR

15)

drugcharacterization1medicinalproductZOFRANdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, TIDdrugdosageformTABLETdrugadministrationroute048actiondrug5drugrecurreadministration3

activesubstance

activesubstancenameONDANSETRON HYDROCHLORIDE

16)

drugcharacterization1medicinalproductPROTONIXdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, QDdrugdosageformTABLETdrugadministrationroute048actiondrug5drugrecurreadministration3

activesubstance

activesubstancenamePANTOPRAZOLE SODIUM

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 027ca15a-8c9f-422a-8e8d-374f68db15cc, ffc4c349-c863-49bf-b179-caa42b759898, 9dd8 ... 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

17)

drugcharacterization1medicinalproductDILAUDIDdrugstructuredosagenumb9.522drugstructuredosageunit003drugdosagetext9.522 MG, PER DAYdrugadministrationroute037actiondrug4

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

18)

drugcharacterization1medicinalproductTRIAZOLAM.drugstructuredosagenumb1drugstructuredosageunit032drugdosagetext1 DF, QHSdrugdosageformTABLETdrugadministrationroute048actiondrug5drugrecurreadministration3

activesubstance

activesubstancenameTRIAZOLAM

openFDA Info on Medication

Application NumberANDA214219, NDA017892, ANDA074224Brand NameTRIAZOLAM, HALCIONGeneric NameTRIAZOLAMManufacturers Ingenus Pharmaceuticals, LLC, Pharmacia & Upjohn Company LLC, Greenstone LLC, Hi ... product_ndc50742-645, 50742-646, 0009-0017, 59762-3717, 59762-3718, 0054-4858, 0054-4859Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTRIAZOLAMRXCUI198317, 198318, 208681spl_id c8ac1484-0706-4629-9563-1e6b7dac89d8, 35f32dcf-f1d8-4656-b982-02f5a9ede2c4, 21b4 ... spl_set_id a0c99f0b-4122-4611-9b53-80fadfceacb6, a0da0dba-a56d-486b-a45b-e8a7cdfbeac6, 5add ... Package NDC 50742-645-01, 50742-646-01, 50742-646-05, 0009-0017-55, 0009-0017-58, 59762-3717 ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII1HM943223R

19)

drugcharacterization1medicinalproductLEVOTHYROXINE.drugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, QDdrugdosageformTABLETdrugadministrationroute048actiondrug5drugrecurreadministration3

activesubstance

activesubstancenameLEVOTHYROXINE

openFDA Info on Medication

Brand NameLEVOTHYROXINEGeneric NameLEVOTHYROXINEManufacturersDeseret Biologicals, Inc.product_ndc43742-0955Product TypeHUMAN OTC DRUGRouteORALActive IngredientsLEVOTHYROXINEspl_id7c431149-4f46-4c4f-a5bb-c1b1fb705283spl_set_id1a467f8b-2611-4936-af2b-098e4791d6aePackage NDC43742-0955-1NUIN0000175945, M0021504Established Pharmacologic Classl-Thyroxine [EPC]Chemical StructureThyroxine [CS]UNIIQ51BO43MG4

20)

drugcharacterization1medicinalproductLIPITORdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, QDdrugdosageformTABLETdrugadministrationroute048actiondrug5drugrecurreadministration3

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)

drugcharacterization1medicinalproductBUMETANIDE.drugstructuredosagenumb2drugstructuredosageunit003drugdosagetext2 MG TABLET Q AMdrugdosageformTABLETdrugadministrationroute048actiondrug5drugrecurreadministration3

activesubstance

activesubstancenameBUMETANIDE

openFDA Info on Medication

Application Number ANDA074225, NDA018225, ANDA209916, ANDA074441, ANDA202900, ANDA079196, ANDA20972 ... Brand NameBUMETANIDE, BUMEXGeneric NameBUMETANIDEManufacturers Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., Validus Pharmaceu ... product_ndc 14539-700, 14539-701, 14539-702, 30698-630, 30698-631, 30698-632, 0832-0540, 083 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsBUMETANIDERXCUI197417, 197418, 197419, 205488, 205489, 205490, 282486, 1727569spl_id 138f8bdd-34a5-49c6-832f-0d343aa95c7b, a8cdbcbb-2436-4157-9929-e1138035de53, a2d6 ... spl_set_id a51d798c-5847-49b2-ba94-434131848199, 32dfbea3-eb2b-4070-8605-57ce3e6d5a2f, ff5d ... Package NDC 14539-700-01, 14539-700-05, 14539-700-10, 14539-701-01, 14539-701-05, 14539-701- ... NUIN0000175366, N0000175590Physiologic/Pharmacodynamic EffectIncreased Diuresis at Loop of Henle [PE]Established Pharmacologic ClassLoop Diuretic [EPC]UNII0Y2S3XUQ5H

22)

drugcharacterization1medicinalproductLEVOTHROIDdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, QDdrugdosageformTABLETdrugadministrationroute048actiondrug5drugrecurreadministration3

activesubstance

activesubstancenameLEVOTHYROXINE SODIUM