Adverse Event Report

Report

reporttype2Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10023057serious1Date Last Updated08/04/2014receiptdateformat102seriousnessdeath1companynumbPHEH2013US026799occurcountryUSseriousnessother1duplicate1Date Received19/03/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification1

Patient

Onset Age65Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionDeathOutcomeFatal

2)

reactionmeddraversionpt17.0ReactionCardiac arrestOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionUnresponsive to stimuliOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionFallOutcomeUnknown

5)

reactionmeddraversionpt17.0ReactionChronic respiratory failureOutcomeUnknown

6)

reactionmeddraversionpt17.0ReactionAnaphylactic reactionOutcomeUnknown

7)

reactionmeddraversionpt17.0ReactionBronchiectasisOutcomeUnknown

8)

reactionmeddraversionpt17.0ReactionBacterial disease carrierOutcomeUnknown

9)

reactionmeddraversionpt17.0ReactionPneumonia staphylococcalOutcomeUnknown

10)

reactionmeddraversionpt17.0ReactionCystic fibrosisOutcomeUnknown

11)

reactionmeddraversionpt17.0ReactionDyspnoeaOutcomeUnknown

12)

reactionmeddraversionpt17.0ReactionAnkle fractureOutcomeUnknown

13)

reactionmeddraversionpt17.0ReactionSpirometry abnormalOutcomeUnknown

14)

reactionmeddraversionpt17.0ReactionDrug intoleranceOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductTOBIdrugbatchnumbF5046drugauthorizationnumb050753drugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext300 MG, (FOR 28 DAYS, THEN OFF FOR 28 DAYS)drugdosageformSol. Aerosol Metered Dose Inh.drugadministrationroute055drugindicationBRONCHITISdrugrecurreadministration3

openFDA Info on Medication

Application NumberNDA050753Brand NameTOBIGeneric NameTOBRAMYCINManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0494Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTOBRAMYCINRXCUI213194, 348719spl_idcb71e4dc-f6a7-455f-b72c-78cb8a4d3feespl_set_id94f9e516-6bf6-4e30-8dde-8833c25c2560Package NDC0078-0494-61, 0078-0494-91, 0078-0494-71NUIN0000175477, M0000946Established Pharmacologic ClassAminoglycoside Antibacterial [EPC]Chemical StructureAminoglycosides [CS]UNIIVZ8RRZ51VK

2)

drugcharacterization1medicinalproductTOBIdrugauthorizationnumb050753drugdosagetextUNKdrugdosageformSol. Aerosol Metered Dose Inh.drugadministrationroute055drugindicationASTHMAdrugstartdateformat610drugstartdate/05/2013drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA050753Brand NameTOBIGeneric NameTOBRAMYCINManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0494Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTOBRAMYCINRXCUI213194, 348719spl_idcb71e4dc-f6a7-455f-b72c-78cb8a4d3feespl_set_id94f9e516-6bf6-4e30-8dde-8833c25c2560Package NDC0078-0494-61, 0078-0494-91, 0078-0494-71NUIN0000175477, M0000946Established Pharmacologic ClassAminoglycoside Antibacterial [EPC]Chemical StructureAminoglycosides [CS]UNIIVZ8RRZ51VK

3)

drugcharacterization1medicinalproductTOBIdrugauthorizationnumb050753drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextUNK UKN, BID (28 DAYS ON AND 28 DAYS OFF)drugdosageformSol. Aerosol Metered Dose Inh.drugadministrationroute055drugindicationPSEUDOMONAS INFECTIONdrugstartdateformat610drugstartdate/07/2013drugenddateformat610drugenddate/07/2013drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA050753Brand NameTOBIGeneric NameTOBRAMYCINManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0494Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTOBRAMYCINRXCUI213194, 348719spl_idcb71e4dc-f6a7-455f-b72c-78cb8a4d3feespl_set_id94f9e516-6bf6-4e30-8dde-8833c25c2560Package NDC0078-0494-61, 0078-0494-91, 0078-0494-71NUIN0000175477, M0000946Established Pharmacologic ClassAminoglycoside Antibacterial [EPC]Chemical StructureAminoglycosides [CS]UNIIVZ8RRZ51VK

4)

drugcharacterization1medicinalproductTOBIdrugauthorizationnumb050753drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetextUNK UKN, BID (28 DAYS ON AND 28 DAYS OFF)drugdosageformSol. Aerosol Metered Dose Inh.drugadministrationroute055drugstartdateformat610drugstartdate/09/2013drugenddateformat610drugenddate/09/2013drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA050753Brand NameTOBIGeneric NameTOBRAMYCINManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0494Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTOBRAMYCINRXCUI213194, 348719spl_idcb71e4dc-f6a7-455f-b72c-78cb8a4d3feespl_set_id94f9e516-6bf6-4e30-8dde-8833c25c2560Package NDC0078-0494-61, 0078-0494-91, 0078-0494-71NUIN0000175477, M0000946Established Pharmacologic ClassAminoglycoside Antibacterial [EPC]Chemical StructureAminoglycosides [CS]UNIIVZ8RRZ51VK

5)

drugcharacterization2medicinalproductSYMBICORTdrugstructuredosagenumb2drugstructuredosageunit032drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 DF, BID (RINSE MOUTH AFTER USE)drugadministrationroute055actiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA021929Brand NameSYMBICORTGeneric NameBUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATEManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc0186-0370, 0186-0372Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsBUDESONIDE, FORMOTEROL FUMARATERXCUI1246288, 1246290, 1246304, 1246306, 1246314, 1246315, 1246316, 1246317spl_id5b03fd09-2533-4975-88da-a0b9c8495d1espl_set_idfafa4cf1-99c2-43d5-73ad-51f256de3be0Package NDC 0186-0370-20, 0186-0370-28, 0186-0370-60, 0186-0372-20, 0186-0372-28, 0186-0372- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIQ3OKS62Q6X, W34SHF8J2K

6)

drugcharacterization2medicinalproductKLOR-CONdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, QDdrugdosageformCAPSULEdrugadministrationroute048actiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA019123, ANDA209662Brand NameKLOR-CONGeneric NamePOTASSIUM CHLORIDEManufacturersSandoz Inc., Upsher-Smith Laboratories, LLCproduct_ndc66758-110, 66758-160, 0245-5315, 0245-5316, 0245-0360Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPOTASSIUM CHLORIDERXCUI312529, 628953, 628958, 832718, 1867544, 1867547spl_id b6795c1c-762b-4589-a49c-cc2d6854ba65, 0907ea1c-82f3-4ba8-9d1b-3f4fa104d7a2, d947 ... spl_set_id 466170e9-e158-4ccd-b7a3-53dc8c3cd749, 1ff53330-065c-4213-9c0c-ac498621d09d, e61a ... Package NDC 66758-110-06, 66758-110-13, 66758-110-01, 66758-110-05, 66758-160-06, 66758-160- ... UNII660YQ98I10

7)

drugcharacterization2medicinalproductALBUTEROL SULFATEdrugdosagetextUNK UKN, PRN (EVERY SIX HOURS) (UNIT DOSE ALBUTEROL IN 3 ML SALINE)drugadministrationroute055actiondrug5drugrecurreadministration3

openFDA Info on Medication

Application Number ANDA210948, ANDA074454, NDA020983, ANDA074880, ANDA077788, ANDA077839, NDA021457 ... Brand Name ALBUTEROL, ALBUTEROL SULFATE, VENTOLIN HFA, ALBUTEROL SULFATE HFA, PROAIR HFA, P ... Generic NameALBUTEROL SULFATE, ALBUTEROLManufacturers Nivagen Pharmaceuticals Inc, Actavis Pharma, Inc., GlaxoSmithKline LLC, Nephron ... product_ndc 75834-273, 75834-274, 0472-0825, 0173-0682, 0487-9501, 66689-100, 0378-8270, 765 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, RESPIRATORY (INHALATION), INTRABRONCHIALActive IngredientsALBUTEROL SULFATERXCUI 197316, 197318, 755497, 801092, 801095, 859088, 2123076, 630208, 2123072, 745752 ... spl_id b736135f-6e13-3e29-e053-2a95a90a67f4, d30951c8-4054-4a94-85b1-8cdd7e22fe6a, 9c3b ... spl_set_id b735e92d-eb1a-6fc1-e053-2995a90afce2, 8bac1efe-c419-a615-fab5-0770b0ce90d9, d92c ... Package NDC 75834-273-01, 75834-274-01, 0472-0825-16, 0472-0825-04, 0173-0682-20, 0173-0682- ... UNII021SEF3731

8)

drugcharacterization2medicinalproductPOTASSIUM CHLORIDEdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, QDdrugdosageformCAPSULEdrugadministrationroute048actiondrug5drugrecurreadministration3

openFDA Info on Medication

Brand Name KALI MURIATICUM, POTASSIUM CHLORIDE, SORE THROAT 911, KLOR-CON M, POTASSIUM CHLO ... Generic NamePOTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASEManufacturers 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 CATIONspl_id 603fa445-ab7d-3929-e053-2a91aa0afb47, 4dca93f2-d9a9-4ecb-89d2-f67b819f82dc, ebba ... 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, 31722-133-10, 31722-134- ... UNII660YQ98I10, 295O53K152Application 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]

9)

drugcharacterization2medicinalproductHYDRALAZINE HYDROCHLORIDEdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, BIDdrugdosageformTABLETdrugadministrationroute048actiondrug5drugrecurreadministration3

openFDA Info on Medication

Application Number ANDA086242, ANDA040388, ANDA203845, ANDA090255, ANDA213667, ANDA040730, ANDA0884 ... Brand NameHYDRALAZINE HYDROCHLORIDE, HYDRALAZINEGeneric NameHYDRALAZINE HYDROCHLORIDEManufacturers Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., Fresenius Kabi US ... product_ndc 23155-001, 23155-002, 23155-003, 23155-004, 63323-614, 75834-126, 75834-127, 758 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsHYDRALAZINE HYDROCHLORIDERXCUI905199, 905222, 905225, 905395, 966571spl_id 8d61225b-8dc5-4bb9-8f33-b4de90af0bc6, f7d9988c-5e17-412e-b419-23c8ff36f62e, 7bb9 ... spl_set_id a04eefaf-ba3c-448d-8ece-4aa9ab2e3508, c3797028-c625-4f70-ae69-8a5f6f23f1b8, 1fd8 ... Package NDC 23155-001-01, 23155-001-10, 23155-002-10, 23155-002-01, 23155-003-01, 23155-003- ... UNIIFD171B778Y

10)

drugcharacterization2medicinalproductXANAXdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, BID (PRN)drugdosageformTABLETdrugadministrationroute048actiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA021434, NDA018276Brand NameXANAX XR, XANAXGeneric NameALPRAZOLAMManufacturersPharmacia and Upjohn Company LLCproduct_ndc 0009-0057, 0009-0059, 0009-0066, 0009-0068, 0009-0029, 0009-0055, 0009-0090, 000 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 433798, 433799, 433800, 433801, 687022, 687023, 687024, 687025, 141927, 141928, ... spl_iddfdda989-af0a-4c14-871c-b26b7b6da50e, d95506a3-aba6-47f4-83c4-443a4cce678bspl_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)

drugcharacterization2medicinalproductSPIRIVA HANDIHALERdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, QD (NEEDS OVERNIGHT MAILED)drugdosageformCAPSULEdrugadministrationroute055actiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA021395Brand NameSPIRIVA HANDIHALERGeneric NameTIOTROPIUM BROMIDEManufacturersBoehringer Ingelheim Pharmaceuticals, Inc.product_ndc0597-0075Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, RESPIRATORY (INHALATION)Active IngredientsTIOTROPIUM BROMIDE MONOHYDRATERXCUI485032, 580261spl_id61e158db-bf32-4cb5-8e5e-72acd953e493spl_set_id820839ef-e53d-47e8-a3b9-d911ff92e6a9Package NDC0597-0075-41, 0597-0075-75, 0597-0075-47UNIIL64SXO195N

12)

drugcharacterization2medicinalproductPROAIR HFAdrugstructuredosagenumb1drugstructuredosageunit032drugdosagetext1 DF, (2 INHALATIONS EVERY SIX HOURS PRN)drugadministrationroute055actiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA021457Brand NamePROAIR HFAGeneric NameALBUTEROL SULFATEManufacturersTeva Respiratory, LLCproduct_ndc59310-579Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsALBUTEROL SULFATERXCUI745752, 2123072spl_id07738d64-2ab5-4f96-bce1-f92bbb93ef18spl_set_id8e701d71-1dcb-4b84-bada-84e4f04f5e62Package NDC59310-579-22, 59310-579-23UNII021SEF3731

13)

drugcharacterization2medicinalproductFAMOTIDINEdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, BIDdrugdosageformTABLETdrugadministrationroute048actiondrug5drugrecurreadministration3

openFDA Info on Medication

Application Number ANDA075400, ANDA077351, ANDA206531, ANDA090837, ANDA078916, ANDA090283, ANDA0755 ... Brand Name ACID CONTROLLER, HARRIS TEETER ACID REDUCER, HEARTBURN PREVENTION, FAMOTIDINE, R ... Generic NameFAMOTIDINEManufacturers H E B, Harris Teeter, LLC, Kroger Company, Wal-Mart Stores, Inc., Aurohealth LLC ... product_ndc 37808-301, 69256-141, 30142-194, 49035-589, 58602-705, 37808-042, 0536-1298, 646 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsFAMOTIDINERXCUI 199047, 310273, 284245, 204441, 1743833, 310274, 104094, 206873, 199739, 104095, ... spl_id 1f77609d-de4d-4f77-9472-a072f8d73890, f33706dc-725a-4d6d-af1e-ede3740b1674, 5445 ... spl_set_id 813d742f-8f3d-4f18-a6c5-03eea946f976, af2c0c51-ac28-4bf4-8e60-ba6e12bfc302, c978 ... Package NDC 37808-301-65, 37808-301-72, 69256-141-65, 30142-194-71, 30142-194-02, 30142-194- ... NUIN0000000151, N0000175784Mechanism of ActionHistamine H2 Receptor Antagonists [MoA]Established Pharmacologic ClassHistamine-2 Receptor Antagonist [EPC]UNII5QZO15J2Z8

14)

drugcharacterization2medicinalproductZOLOFTdrugstructuredosagenumb2drugstructuredosageunit032drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 DF, BIDdrugdosageformTABLETdrugadministrationroute048actiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA020990, NDA019839Brand NameZOLOFTGeneric NameSERTRALINE HYDROCHLORIDEManufacturersRoerigproduct_ndc0049-0050, 0049-4960, 0049-4900, 0049-4910Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066spl_id665a145d-44fb-4fef-a3c1-2aac26e0715cspl_set_idfe9e8b7d-61ea-409d-84aa-3ebd79a046b5Package NDC 0049-4960-30, 0049-4960-50, 0049-4900-30, 0049-4900-66, 0049-4900-73, 0049-4900- ... UNIIUTI8907Y6X

15)

drugcharacterization2medicinalproductSINGULAIRdrugstructuredosagenumb1drugstructuredosageunit032drugdosagetext1 DF, DAILYdrugdosageformTABLETdrugadministrationroute048actiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA020829, NDA020830, NDA021409Brand NameSINGULAIRGeneric NameMONTELUKAST SODIUMManufacturersMerck Sharp & Dohme Corp.product_ndc0006-9117, 0006-3841, 0006-1711, 0006-9275Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMONTELUKAST SODIUMRXCUI153892, 153893, 200224, 242438, 261367, 311759, 351246, 404406spl_id96717981-6ea2-4720-a749-e14f1559511fspl_set_id8c166755-7711-4df9-d689-8836a1a70885Package NDC 0006-3841-30, 0006-3841-14, 0006-1711-31, 0006-1711-54, 0006-9275-31, 0006-9275- ... UNIIU1O3J18SFL

16)

drugcharacterization2medicinalproductVITAMIN B12drugstructuredosagenumb1drugstructuredosageunit032drugdosagetext1 DF, DAILYdrugdosageformTABLETdrugadministrationroute048actiondrug5drugrecurreadministration3

17)

drugcharacterization2medicinalproductIRONdrugstructuredosagenumb1drugstructuredosageunit032drugdosagetext1 DF, DAILYdrugdosageformTABLETdrugadministrationroute048actiondrug5drugrecurreadministration3

openFDA Info on Medication

Brand NameFERRUM METALLICUM, BILIOUSNESS DIARRHEAGeneric NameIRONManufacturersWashington Homeopathic Products, Boiron, Natural Health Supply, Seroyal USAproduct_ndc 71919-289, 0220-2055, 0220-2085, 0220-2051, 0220-2050, 0220-2047, 64117-791, 022 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsIRONspl_id 7e4e7e58-41be-89a2-e053-2a91aa0a790b, 8591b12c-51c9-9839-e053-2a91aa0aa937, 8737 ... spl_set_id bbca0ba2-37e5-4667-80ff-365490b25624, 8591b12c-51c8-9839-e053-2a91aa0aa937, 8737 ... Package NDC 71919-289-07, 71919-289-08, 71919-289-09, 71919-289-10, 0220-2055-41, 0220-2085- ... UNIIE1UOL152H7

18)

drugcharacterization2medicinalproductFOLIC ACIDdrugstructuredosagenumb1drugstructuredosageunit032drugdosagetext1 DF, DAILYdrugdosageformTABLETdrugadministrationroute048actiondrug5drugrecurreadministration3

openFDA Info on Medication

Application Number ANDA040796, ANDA204418, ANDA202437, ANDA091145, ANDA211064, ANDA202522, ANDA0407 ... Brand NameFOLIC ACID, VENEXA, VITREXYL, VITRANOLGeneric NameFOLIC ACIDManufacturers Leading Pharma, LLC, Marlex Pharmaceuticals Inc, PureTek Corporation, Cadila Pha ... product_ndc 69315-127, 10135-182, 59088-176, 71209-007, 58657-150, 11534-165, 58657-151, 731 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSActive Ingredients FOLIC ACID, .ALPHA.-TOCOPHEROL ACETATE, DL-, MAGNESIUM OXIDE, CHROMIUM NICOTINAT ... RXCUI310410, 237786spl_id 92322e52-3179-4738-8c8a-14fef62311d4, ba726c8a-bfad-11f7-e053-2995a90a239e, ba13 ... spl_set_id 1ba8c407-9613-4319-ac40-0a429cb0f3f4, 35cd5498-0af8-4bcc-a755-bf30f37b091a, ba13 ... Package NDC 69315-127-01, 69315-127-10, 10135-182-01, 10135-182-10, 59088-176-54, 71209-007- ... UNII 935E97BOY8, WR1WPI7EW8, 3A3U0GI71G, A150AY412V, 68Y4CF58BV, 81AH48963U, H6241UJ2 ... NUIM0022797, N0000175952, N0000193618, M0001797, M0022794, N0000175951Chemical StructureVitamin D [CS], Ascorbic Acid [CS], Vitamin B 12 [CS]Established Pharmacologic ClassVitamin D [EPC], Vitamin C [EPC], Vitamin B12 [EPC]

19)

drugcharacterization2medicinalproductAYRdrugdosagetextUNK UKN, PRNdrugadministrationroute045actiondrug5drugrecurreadministration3

20)

drugcharacterization2medicinalproductASTELINdrugstructuredosagenumb2drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb2drugintervaldosagedefinition803drugdosagetext2 DF, BIW (PRN)drugdosageformSpraydrugadministrationroute045actiondrug5drugrecurreadministration3

21)

drugcharacterization2medicinalproductDULERAdrugstructuredosagenumb2drugstructuredosageunit032drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 DF, BID (RINSE MOUNTH AFTER USE)drugadministrationroute055actiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA022518Brand NameDULERAGeneric NameMOMETASONE FUROATE AND FORMOTEROL FUMARATE DIHYDRATEManufacturersMerck Sharp & Dohme Corp.product_ndc0085-2223, 0085-7206, 0085-4610Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsMOMETASONE FUROATE, FORMOTEROL FUMARATERXCUI 1246308, 1246310, 1246311, 1246313, 1660933, 1660934, 1660937, 1660938, 2196590, ... spl_id1ef5a40c-4197-4f13-aec6-51c20412bbadspl_set_id116464ce-cfd8-4b9f-8b5a-3a114b6ff2b1Package NDC 0085-7206-01, 0085-7206-07, 0085-7206-08, 0085-7206-02, 0085-4610-01, 0085-4610- ... UNII04201GDN4R, W34SHF8J2K

22)

drugcharacterization2medicinalproductLOVASTATINdrugstructuredosagenumb1drugstructuredosageunit032drugdosagetext1 DF, DAILYdrugdosageformTABLETdrugadministrationroute048actiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberANDA078296, ANDA075828, ANDA075991, NDA021316, ANDA075551, ANDA075636Brand NameLOVASTATIN, ALTOPREVGeneric NameLOVASTATINManufacturers Lupin Pharmaceuticals, Inc., Actavis Pharma, Inc., Carlsbad Technology, Inc., Co ... product_ndc 68180-467, 68180-468, 68180-469, 45963-633, 45963-634, 45963-635, 61442-141, 614 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLOVASTATINRXCUI197903, 197904, 197905, 359731, 359732, 433849, 884383, 997006, 997007spl_id c604f04e-6251-4b55-9cf3-6b534605137b, fa0b909d-8e24-416d-9674-b18bb436e657, b180 ... spl_set_id df7ddf4f-d569-431e-81f1-9129d7043150, 10a557fe-6620-4b15-862a-d3ff5dece612, 0a68 ... Package NDC 68180-467-09, 68180-467-07, 68180-467-01, 68180-467-03, 68180-467-05, 68180-468- ... NUIN0000175589, N0000000121Established Pharmacologic ClassHMG-CoA Reductase Inhibitor [EPC]Mechanism of ActionHydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]UNII9LHU78OQFD

23)

drugcharacterization2medicinalproductOMEPRAZOLEdrugstructuredosagenumb1drugstructuredosageunit032drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 DF, QD (PRN)drugdosageformCAPSULEdrugadministrationroute048actiondrug5drugrecurreadministration3

openFDA Info on Medication

Application Number NDA022032, ANDA210593, ANDA207891, ANDA075410, ANDA075757, ANDA206877, NDA209400 ... Brand Name GOOD NEIGHBOR PHARMACY OMEPRAZOLE, KIRKLAND SIGNATURE OMEPRAZOLE, OMEPRAZOLE, AC ... Generic NameOMEPRAZOLE, OMEPRAZOLE MAGNESIUMManufacturers Amerisource Bergen, Costco Wholesale Company, INNOVUS PHARMACEUTICALS, INC., OHM ... product_ndc 46122-281, 63981-915, 57483-740, 51660-029, 62175-114, 62175-118, 62175-136, 078 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOMEPRAZOLE, OMEPRAZOLE MAGNESIUMRXCUI402014, 198051, 199119, 200329, 2003656spl_id f8450f59-9629-41d2-92eb-9ac30593ea31, 8c9d9c38-9da6-4f99-9f08-26ec4693fa55, ce5c ... spl_set_id 5ee3cb79-5c0c-456f-b5d5-d5a008bbd118, 48a44d0c-3502-430b-8b75-188a49d14da2, ce5c ... Package NDC 46122-281-04, 46122-281-74, 63981-915-55, 57483-740-01, 57483-740-42, 51660-029- ... NUIN0000175525, N0000000147, N0000182140Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNIIKG60484QX9, 426QFE7XLK

24)

drugcharacterization2medicinalproductL-THYROXINE SODIUMdrugstructuredosagenumb1drugstructuredosageunit032drugdosagetext1 DF, DAILYdrugdosageformTABLETdrugadministrationroute048actiondrug5drugrecurreadministration3

25)

drugcharacterization2medicinalproductBENICAR HCTdrugstructuredosagenumb1drugstructuredosageunit032drugdosagetext1 DF, DAILYdrugdosageformTABLETdrugadministrationroute048actiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA021532Brand NameBENICAR HCTGeneric NameOLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDEManufacturersDaiichi Sankyo Inc.product_ndc65597-105, 65597-106, 65597-107Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOLMESARTAN MEDOXOMIL, HYDROCHLOROTHIAZIDERXCUI403853, 403854, 403855, 847042, 847055, 847060spl_id746adc8b-b1e5-40f2-ba7c-6a7b1be92214spl_set_id6bbc032a-3cc4-4b1d-8124-1784214a2821Package 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]UNII0J48LPH2TH, 6M97XTV3HD

26)

drugcharacterization2medicinalproductASPIRINdrugdosagetextUNKdrugindicationHAEMORRHAGEactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application Numberpart343Brand Name ASPIRIN ADULT LOW DOSE, BAYER GENUINE ASPIRIN, ZEE ASPIRIN, ENTERIC COATED ASPIR ... Generic NameASPIRIN, ASPIRIN 81 MG, ASPIRIN 81MG, ASPIRIN 325 MGManufacturers Wal-Mart Stores Inc, Unifirst First Aid Corporation, Cintas Corporation, Strateg ... product_ndc 49035-914, 47682-456, 42961-044, 49348-937, 0363-0587, 70000-0218, 70000-0170, 6 ... Product TypeHUMAN OTC DRUGRouteORAL, RECTALActive IngredientsASPIRIN, CALCIUM CARBONATERXCUI 308416, 211874, 212033, 198467, 318272, 1722689, 1722695, 198471, 825180, 198464 ... spl_id a1833a99-76cc-47fb-80fb-3a6507a2db3e, acc2acbd-b310-e26a-e053-2a95a90a1874, 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

27)

drugcharacterization2medicinalproductACCUPRILdrugdosagetextUNKdrugindicationCOUGHactiondrug5drugrecurreadministration3

openFDA Info on Medication

Application NumberNDA019885Brand NameACCUPRILGeneric NameQUINAPRIL HYDROCHLORIDEManufacturersParke-Davis Div of Pfizer Incproduct_ndc 0071-0527, 0071-0530, 0071-0532, 0071-0535, 0071-1205, 0071-1410, 0071-1620, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsQUINAPRIL HYDROCHLORIDERXCUI207891, 207892, 207893, 207895, 312748, 312749, 312750, 314203spl_id720d7928-818b-4fb3-adf3-f0c0c080e4f0spl_set_id63cf5651-d52c-4d27-9fd4-ed9cd9724dffPackage NDC 0071-0527-23, 0071-0527-40, 0071-0530-23, 0071-0530-40, 0071-0532-23, 0071-0532- ... UNII33067B3N2M

28)

drugcharacterization2medicinalproductCORTICOSTEROIDSdrugdosagetextUNK UKN, (DOSE TAPERED)actiondrug5drugrecurreadministration3

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