Adverse Event Report

Report

Version of Safety Report ID5Safety Report ID12215804primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate19/04/2021reporttype1serious1seriousnessother1receivedateformat102Date Received28/03/2016receiptdateformat102Date Last Updated14/01/2021fulfillexpeditecriteria1companynumbUS-JAZZ-2016-US-005264duplicate1

Report Duplicate

duplicatesourceJAZZduplicatenumbUS-JAZZ-2016-US-005264

Primary Source

reportercountryUSqualification1

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

SexMale

Contents

Reaction

1)

reactionmeddraversionpt23.1ReactionNasopharyngitisOutcomeUnknown

2)

reactionmeddraversionpt23.1ReactionRenal failureOutcomeRecovered/resolved

3)

reactionmeddraversionpt23.1ReactionChronic kidney diseaseOutcomeRecovering/resolving

Drug

1)

drugcharacterization2medicinalproductCOENZYME Q10drugdosagetextUNKdrugdosageformCAPSULEdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate06/01/2016drugrecurreadministration3

activesubstance

activesubstancenameDIETARY SUPPLEMENT\UBIDECARENONE

2)

drugcharacterization2medicinalproductMIRAPEXdrugstructuredosagenumb.375drugstructuredosageunit003drugdosagetext0.375 MG, UNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate01/12/2015drugenddateformat102drugenddate01/12/2015drugrecurreadministration3

activesubstance

activesubstancenamePRAMIPEXOLE DIHYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA022421Brand NameMIRAPEX ERGeneric NamePRAMIPEXOLE DIHYDROCHLORIDEManufacturersBoehringer Ingelheim Pharmaceuticals, Inc.product_ndc0597-0109, 0597-0285, 0597-0113, 0597-0286, 0597-0115, 0597-0287, 0597-0116Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPRAMIPEXOLE DIHYDROCHLORIDERXCUI 901534, 901537, 901541, 901543, 901546, 901547, 901550, 901551, 901555, 901557, ... spl_id77d8974c-9e8a-4700-8445-458b31b6ce31spl_set_ide2902ed1-cfeb-4815-adc3-129c577917a1Package NDC 0597-0109-30, 0597-0109-07, 0597-0109-17, 0597-0285-30, 0597-0285-07, 0597-0285- ... UNII3D867NP06J

3)

drugcharacterization2medicinalproductIPRATROPIUMdrugdosagetextUNKdrugdosageformSPRAYdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate01/12/2015drugrecurreadministration3

activesubstance

activesubstancenameIPRATROPIUM

4)

drugcharacterization2medicinalproductNEURONTINdrugdosagetextUNKdrugdosageformCAPSULEdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate01/12/2015drugenddateformat102drugenddate01/12/2015drugrecurreadministration3

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

5)

drugcharacterization2medicinalproductCYCLOBENZAPRINE HYDROCHLORIDE.drugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate01/12/2014drugenddateformat102drugenddate01/12/2015drugrecurreadministration3

activesubstance

activesubstancenameCYCLOBENZAPRINE HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA078722, ANDA077563, ANDA208170, ANDA078643, ANDA213324, ANDA090478, ANDA0716 ... Brand NameCYCLOBENZAPRINE HYDROCHLORIDE, FEXMID, CYCLOBENZAPRINE, AMRIXGeneric NameCYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINEManufacturers SA3, LLC, Jubilant Cadista Pharmaceuticals Inc., Advagen Pharma Limited, Rising ... product_ndc 69420-1001, 59746-177, 59746-211, 59746-735, 72888-012, 72888-013, 72888-014, 16 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCYCLOBENZAPRINE HYDROCHLORIDERXCUI828299, 828320, 828348, 828301, 828353, 828358, 828355, 828359spl_id 2bf3a68c-688f-44be-bb49-37d647ffd58f, cad3a28c-244f-42be-83f3-89f8ad45482d, d1ff ... spl_set_id a4ae481f-9e47-470a-b4d1-5a33c0df8761, 592871f6-0eb2-4624-9e10-bd8bf767c002, b216 ... Package NDC 69420-1001-3, 69420-1001-2, 69420-1001-1, 59746-211-06, 59746-211-10, 59746-735- ... UNII0VE05JYS2P

6)

drugcharacterization2medicinalproductNIASPAN ERdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate04/12/2011drugenddateformat102drugenddate01/12/2015drugrecurreadministration3

activesubstance

activesubstancenameNIACIN

7)

drugcharacterization2medicinalproductMELATONINdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameMELATONIN

openFDA Info on Medication

Brand NameMELATONIN, MELATONIN PHENOLIC, MELATONIN CORD, MELATONIN 1527Generic NameMELATONINManufacturers BioActive Nutritional, Inc., Energique, Inc., Professional Complementary Health ... product_ndc43857-0086, 44911-0247, 44911-0194, 63083-1527, 43742-0771Product TypeHUMAN OTC DRUGRouteORALActive IngredientsMELATONINspl_id e189499d-9da3-43fc-8a0b-9d5dd0923b11, 904c041a-ff84-4152-9b10-ea5d1b669d24, 0673 ... spl_set_id cd82eb5d-a44a-4512-ad65-0fffae70d1d0, 895cb8a5-33ea-4764-86a6-1da513dcd2c1, 9a59 ... Package NDC43857-0086-1, 44911-0247-1, 44911-0194-1, 63083-1527-1, 43742-0771-1UNIIJL5DK93RCL

8)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugdosagetextDOSE ADJUSTMENTSdrugdosageformORAL SOLUTIONdrugadministrationroute048drugindicationCATAPLEXYdrugstartdateformat610drugstartdate/12/2011drugenddateformat610drugenddate/07/2013actiondrug4

activesubstance

activesubstancenameSODIUM OXYBATE

openFDA Info on Medication

Application NumberNDA021196Brand NameXYREMGeneric NameSODIUM OXYBATEManufacturersJazz Pharmaceuticals, Inc.product_ndc68727-100Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSODIUM OXYBATERXCUI349482, 352257spl_id507868f6-2c1d-488d-8132-38d23218caf3spl_set_id926eb076-a4a8-45e4-91ef-411f0aa4f3caPackage NDC68727-100-01UNII7G33012534

9)

drugcharacterization2medicinalproductKRILL OILdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate06/01/2016drugrecurreadministration3

activesubstance

activesubstancenameDIETARY SUPPLEMENT\KRILL OIL

10)

drugcharacterization2medicinalproductMIRAPEXdrugstructuredosagenumb.25drugstructuredosageunit003drugdosagetext0.25 MG, UNKdrugdosageformTABLETdrugstartdateformat102drugstartdate06/01/2016drugenddateformat102drugenddate06/01/2016drugrecurreadministration3

activesubstance

activesubstancenamePRAMIPEXOLE DIHYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA022421Brand NameMIRAPEX ERGeneric NamePRAMIPEXOLE DIHYDROCHLORIDEManufacturersBoehringer Ingelheim Pharmaceuticals, Inc.product_ndc0597-0109, 0597-0285, 0597-0113, 0597-0286, 0597-0115, 0597-0287, 0597-0116Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPRAMIPEXOLE DIHYDROCHLORIDERXCUI 901534, 901537, 901541, 901543, 901546, 901547, 901550, 901551, 901555, 901557, ... spl_id77d8974c-9e8a-4700-8445-458b31b6ce31spl_set_ide2902ed1-cfeb-4815-adc3-129c577917a1Package NDC 0597-0109-30, 0597-0109-07, 0597-0109-17, 0597-0285-30, 0597-0285-07, 0597-0285- ... UNII3D867NP06J

11)

drugcharacterization2medicinalproductTOPROL XLdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate01/12/2015drugenddateformat102drugenddate01/12/2015drugrecurreadministration3

activesubstance

activesubstancenameMETOPROLOL SUCCINATE

openFDA Info on Medication

Application NumberNDA019962Brand NameTOPROL XLGeneric NameMETOPROLOL SUCCINATEManufacturersAralez Pharmaceuticals US Inc.product_ndc70347-025, 70347-050, 70347-100, 70347-200Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETOPROLOL SUCCINATERXCUI866412, 866414, 866419, 866421, 866427, 866429, 866436, 866438spl_ided7de3bc-9f5b-4763-953c-b112d322e0ffspl_set_id991fe00b-498b-400e-9e5b-921cb07d9b2cPackage NDC 70347-025-01, 70347-025-02, 70347-025-03, 70347-050-01, 70347-050-02, 70347-050- ... UNIITH25PD4CCB

12)

drugcharacterization2medicinalproductERGOCALCIFEROL.drugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate01/01/2001drugrecurreadministration3

activesubstance

activesubstancenameERGOCALCIFEROL

openFDA Info on Medication

Application NumberANDA090455, NDA003444, ANDA091004, ANDA080704, ANDA040833Brand NameVITAMIN D, DRISDOL, ERGOCALCIFEROLGeneric NameERGOCALCIFEROLManufacturers Strides Pharma Science Limited, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmac ... product_ndc64380-737, 23155-809, 30698-493, 64980-157, 69452-151, 62332-464Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERGOCALCIFEROLRXCUI1367410, 1367416spl_id 08a99dff-5765-49b0-b289-4e854d3c6725, 9c09c2d2-ef29-4654-be7d-ed3b2b508f43, 9ffc ... spl_set_id 2c4c0a36-12cf-444d-9d57-de983eef4d36, 96da2c1e-6c5e-4df0-8166-3de53c08a701, acb6 ... Package NDC 64380-737-06, 64380-737-25, 23155-809-01, 30698-493-01, 64980-157-01, 69452-151- ... NUIM0007651, N0000175909Chemical StructureErgocalciferols [CS]Established Pharmacologic ClassProvitamin D2 Compound [EPC]UNIIVS041H42XC

13)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugstructuredosagenumb2.25drugstructuredosageunit002drugdosagetext2.25 G, BIDdrugdosageformORAL SOLUTIONdrugadministrationroute048drugindicationNARCOLEPSYdrugstartdateformat610drugstartdate/11/2011drugenddateformat610drugenddate/12/2011actiondrug4

activesubstance

activesubstancenameSODIUM OXYBATE

openFDA Info on Medication

Application NumberNDA021196Brand NameXYREMGeneric NameSODIUM OXYBATEManufacturersJazz Pharmaceuticals, Inc.product_ndc68727-100Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSODIUM OXYBATERXCUI349482, 352257spl_id507868f6-2c1d-488d-8132-38d23218caf3spl_set_id926eb076-a4a8-45e4-91ef-411f0aa4f3caPackage NDC68727-100-01UNII7G33012534

14)

drugcharacterization2medicinalproductASMANEXdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate06/01/2016drugrecurreadministration3

activesubstance

activesubstancenameMOMETASONE FUROATE

openFDA Info on Medication

Application NumberNDA021067Brand NameASMANEXGeneric NameMOMETASONE FUROATEManufacturersOrganon LLCproduct_ndc78206-114, 78206-115Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsMOMETASONE FUROATERXCUI746803, 746804, 746810, 746811, 746812, 746813, 746814, 746815, 790283, 790284spl_id01be1fad-890f-4023-9c96-325bc50cda4dspl_set_id10b36fb2-6b0d-4f20-b197-3564d6f594b9Package NDC 78206-114-03, 78206-114-04, 78206-114-02, 78206-114-01, 78206-114-59, 78206-115- ... UNII04201GDN4R

15)

drugcharacterization2medicinalproductCRESTORdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate06/01/2016drugrecurreadministration3

activesubstance

activesubstancenameROSUVASTATIN CALCIUM

openFDA Info on Medication

Application NumberNDA021366Brand NameCRESTORGeneric NameROSUVASTATIN CALCIUMManufacturersAstraZeneca Pharmaceuticals LPproduct_ndc 0310-7560, 0310-7570, 0310-7580, 0310-7590, 0310-0751, 0310-0755, 0310-0752, 031 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsROSUVASTATIN CALCIUMRXCUI859419, 859421, 859424, 859426, 859747, 859749, 859751, 859753spl_id08039402-2a60-4599-83b5-1c63b85ead70, d9298e4d-e35f-4ba4-9fdf-1a8d0358707fspl_set_id325a5d0e-9a72-4015-9fcd-1655fb504cee, bb0f3b5e-4bc6-41c9-66b9-6257e2513512Package NDC 0310-7560-90, 0310-7570-90, 0310-7580-90, 0310-7590-30, 0310-0755-90, 0310-0751- ... UNII83MVU38M7Q

16)

drugcharacterization2medicinalproductADENOSINE.drugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate01/12/2014drugenddateformat102drugenddate01/12/2015drugrecurreadministration3

activesubstance

activesubstancenameADENOSINE

openFDA Info on Medication

Brand Name BVBLAB SQUALAN SERUM STI CK 70, PEPPLUS WRINKLE EYE, CELGEN PEARL CALMING SOLUTI ... Generic NameADENOSINEManufacturers FICC Co., Ltd., Picobio Co., Ltd, BBHC CO., LTD, NOKSIBCHO cosmetic Co., Ltd., A ... product_ndc 81647-130, 72211-004, 76731-212, 73590-0038, 69153-070, 73113-030, 0703-8776, 07 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteTOPICAL, INTRAVENOUSActive IngredientsADENOSINEspl_id a83ca0df-23a7-475f-badf-da53db3f96bb, cfd2a317-e0e9-622f-e053-2a95a90af3a7, c79d ... spl_set_id 0ecd10e5-5988-46fe-8be0-84e383703d3b, 87b4be6d-70a0-4062-8ed1-f2ff87144ed6, c79d ... Package NDC 81647-130-01, 81647-130-02, 72211-004-01, 72211-004-02, 76731-212-01, 73590-0038 ... NUIN0000178375, N0000175788Established Pharmacologic ClassAdenosine Receptor Agonist [EPC]Mechanism of ActionAdenosine Receptor Agonists [MoA]UNIIK72T3FS567Application Number ANDA077425, ANDA205331, ANDA202313, ANDA090212, ANDA077283, ANDA203883, ANDA0771 ... RXCUI1654035, 1654040, 727355, 727360, 1654169, 1654186, 727361

17)

drugcharacterization2medicinalproductLORAZEPAM.drugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate17/10/2014drugenddateformat102drugenddate27/10/2014drugrecurreadministration3

activesubstance

activesubstancenameLORAZEPAM

openFDA Info on Medication

Application Number ANDA076150, NDA018140, ANDA203572, ANDA074282, ANDA072755, ANDA090260, ANDA07502 ... Brand NameLORAZEPAM, LOREEV XR, ATIVANGeneric NameLORAZEPAMManufacturers International Medication Systems, Limited, Hikma Pharmaceuticals USA Inc., Aurol ... product_ndc 76329-8261, 0641-6207, 13107-083, 13107-084, 13107-085, 0409-6778, 0054-3532, 01 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsLORAZEPAMRXCUI 238100, 197900, 197901, 197902, 1665188, 311376, 238101, 1665326, 2569564, 25695 ... spl_id 8b30da4f-e5a1-4e8a-9971-b5c687508d81, 4f2988b1-2854-4051-962f-07cc925608ab, 66ed ... spl_set_id 7dda070d-7809-46c4-8592-eb4e4c509707, b79b38ee-c29d-4099-964f-000031f47f5a, 5b85 ... Package NDC 76329-8261-1, 0641-6207-01, 0641-6207-25, 13107-083-11, 13107-083-01, 13107-083- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIO26FZP769L

18)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugstructuredosagenumb4.5drugstructuredosageunit002drugdosagetext4.5 G, BIDdrugdosageformORAL SOLUTIONdrugadministrationroute048drugstartdateformat610drugstartdate/07/2013actiondrug4

activesubstance

activesubstancenameSODIUM OXYBATE

openFDA Info on Medication

Application NumberNDA021196Brand NameXYREMGeneric NameSODIUM OXYBATEManufacturersJazz Pharmaceuticals, Inc.product_ndc68727-100Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSODIUM OXYBATERXCUI349482, 352257spl_id507868f6-2c1d-488d-8132-38d23218caf3spl_set_id926eb076-a4a8-45e4-91ef-411f0aa4f3caPackage NDC68727-100-01UNII7G33012534

19)

drugcharacterization2medicinalproductLUNESTAdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate01/12/2015drugenddateformat102drugenddate01/12/2015drugrecurreadministration3

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

20)

drugcharacterization2medicinalproductPLAVIXdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate01/12/2014drugenddateformat102drugenddate02/01/2015drugrecurreadministration3

activesubstance

activesubstancenameCLOPIDOGREL BISULFATE

openFDA Info on Medication

Application NumberNDA020839Brand NamePLAVIXGeneric NameCLOPIDOGRELManufacturerssanofi-aventis U.S. LLC, Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnershipproduct_ndc0024-1171, 0024-1332, 63653-1171, 63653-1332Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLOPIDOGREL BISULFATERXCUI213169, 309362, 749196, 749198spl_id4e097e4e-304d-4830-a350-d617662aa303, fdbc18a6-b364-4f85-9fd1-71d04b3a7ab1spl_set_idde8b0b67-eb25-4684-83b5-7ad785314227, 01b14603-8f29-4fa3-8d7e-9d523f802e0bPackage NDC 0024-1171-90, 0024-1332-30, 63653-1171-6, 63653-1171-1, 63653-1171-3, 63653-1171 ... UNII08I79HTP27

21)

drugcharacterization2medicinalproductMORPHINE SULFdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate11/03/2014drugenddateformat102drugenddate31/03/2014drugrecurreadministration3

activesubstance

activesubstancenameMORPHINE SULFATE

22)

drugcharacterization2medicinalproductSINGULAIRdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameMONTELUKAST SODIUM

openFDA Info on Medication

Application NumberNDA020830, NDA021409, NDA020829Brand NameSINGULAIRGeneric NameMONTELUKAST SODIUMManufacturersOrganon LLCproduct_ndc78206-170, 78206-171, 78206-173, 78206-172Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMONTELUKAST SODIUMRXCUI153892, 153893, 200224, 242438, 261367, 311759, 351246, 404406spl_id679860ff-4c1d-432d-856a-90d4eea82ea0spl_set_id482dcc92-b47f-4ea6-854a-f5ac2aea7842Package NDC78206-171-01, 78206-170-01, 78206-173-01, 78206-172-01, 78206-172-02UNIIU1O3J18SFL

23)

drugcharacterization2medicinalproductCOENZYME Q10drugdosagetextUNKdrugdosageformCAPSULEdrugenddateformat102drugenddate01/03/2016drugrecurreadministration3

activesubstance

activesubstancenameDIETARY SUPPLEMENT\UBIDECARENONE

24)

drugcharacterization2medicinalproductFLOVENT HFAdrugdosagetextUNKdrugdosageformINHALERdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate06/01/2016drugenddateformat102drugenddate06/01/2016drugrecurreadministration3

activesubstance

activesubstancenameFLUTICASONE PROPIONATE

openFDA Info on Medication

Application NumberNDA021433Brand NameFLOVENT HFAGeneric NameFLUTICASONE PROPIONATEManufacturersGlaxoSmithKline LLCproduct_ndc0173-0718, 0173-0719, 0173-0720Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsFLUTICASONE PROPIONATERXCUI895994, 895996, 895999, 896001, 896004, 896006spl_id55e108b2-ddd9-4175-b7c4-acbccba6ed67spl_set_idb49ed7c1-123e-4b1d-fea6-0c6839fd9d6aPackage NDC0173-0718-20, 0173-0719-20, 0173-0720-20UNIIO2GMZ0LF5W

25)

drugcharacterization2medicinalproductIRONdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate06/01/2016drugrecurreadministration3

activesubstance

activesubstancenameIRON

openFDA Info on Medication

Brand NameFERRUM METALLICUM, BILIOUSNESS DIARRHEAGeneric NameIRONManufacturersBoiron, Natural Health Supply, Washington Homeopathic Products, Seroyal USAproduct_ndc 0220-2055, 0220-2085, 0220-2051, 0220-2050, 0220-2047, 64117-791, 0220-2046, 022 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsIRONspl_id 8591b12c-51c9-9839-e053-2a91aa0aa937, 87372ec7-ead0-90b1-e053-2a91aa0afadf, 8591 ... spl_set_id 8591b12c-51c8-9839-e053-2a91aa0aa937, 87372ec7-eacf-90b1-e053-2a91aa0afadf, 8591 ... Package NDC 0220-2055-41, 0220-2085-41, 0220-2051-41, 0220-2050-41, 0220-2047-41, 64117-791- ... UNIIE1UOL152H7

26)

drugcharacterization2medicinalproductFUROSEMIDE.drugstructuredosagenumb20drugstructuredosageunit003drugdosagetext20 MG, UNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate01/12/2015drugenddateformat102drugenddate01/12/2015drugrecurreadministration3

activesubstance

activesubstancenameFUROSEMIDE

openFDA Info on Medication

Application Number ANDA077293, ANDA207552, ANDA213902, NDA016273, ANDA070655, ANDA212174, ANDA07043 ... Brand Name TOXYCOLOGY MEDICATED COLLECTION SYSTEM, FUROSEMIDE, LASIX, DIASCREEN 12-PANEL ME ... Generic NameFUROSEMIDEManufacturers IT3 Medical LLC, Amneal Pharmaceuticals LLC, Gland Pharma Limited, Validus Pharm ... product_ndc 70529-549, 70121-1076, 70121-1163, 70121-1164, 68083-432, 68083-433, 68083-434, ... Product TypeHUMAN PRESCRIPTION DRUGRXCUI 310429, 1038558, 1719286, 1719290, 1719291, 197732, 200801, 200809, 205732, 3139 ... spl_id 29531d06-4e7f-4e26-93d0-1d98e58966d2, c22d0330-1b76-420a-a84b-8ea59f8733a7, e7bd ... spl_set_id a78407a8-3d3e-4eb5-9e3f-b32a1b8015e4, d5b9f12e-d1e9-42de-90f2-c9ba33a86457, 6447 ... Package NDC 70529-549-01, 70529-061-08, 68345-883-50, 70121-1163-1, 70121-1163-5, 70121-1164 ... RouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsFUROSEMIDENUIN0000175366, N0000175590Physiologic/Pharmacodynamic EffectIncreased Diuresis at Loop of Henle [PE]Established Pharmacologic ClassLoop Diuretic [EPC]UNII7LXU5N7ZO5

27)

drugcharacterization2medicinalproductFUROSEMIDE.drugstructuredosagenumb40drugstructuredosageunit003drugdosagetext40 MG, UNKdrugdosageformTABLETdrugenddateformat102drugenddate01/03/2016drugrecurreadministration3

activesubstance

activesubstancenameFUROSEMIDE

openFDA Info on Medication

Application Number ANDA077293, ANDA207552, ANDA213902, NDA016273, ANDA070655, ANDA212174, ANDA07043 ... Brand Name TOXYCOLOGY MEDICATED COLLECTION SYSTEM, FUROSEMIDE, LASIX, DIASCREEN 12-PANEL ME ... Generic NameFUROSEMIDEManufacturers IT3 Medical LLC, Amneal Pharmaceuticals LLC, Gland Pharma Limited, Validus Pharm ... product_ndc 70529-549, 70121-1076, 70121-1163, 70121-1164, 68083-432, 68083-433, 68083-434, ... Product TypeHUMAN PRESCRIPTION DRUGRXCUI 310429, 1038558, 1719286, 1719290, 1719291, 197732, 200801, 200809, 205732, 3139 ... spl_id 29531d06-4e7f-4e26-93d0-1d98e58966d2, c22d0330-1b76-420a-a84b-8ea59f8733a7, e7bd ... spl_set_id a78407a8-3d3e-4eb5-9e3f-b32a1b8015e4, d5b9f12e-d1e9-42de-90f2-c9ba33a86457, 6447 ... Package NDC 70529-549-01, 70529-061-08, 68345-883-50, 70121-1163-1, 70121-1163-5, 70121-1164 ... RouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsFUROSEMIDENUIN0000175366, N0000175590Physiologic/Pharmacodynamic EffectIncreased Diuresis at Loop of Henle [PE]Established Pharmacologic ClassLoop Diuretic [EPC]UNII7LXU5N7ZO5

28)

drugcharacterization2medicinalproductAMLODIPINE BESYLATE.drugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate06/01/2016drugenddateformat102drugenddate06/01/2016drugrecurreadministration3

activesubstance

activesubstancenameAMLODIPINE BESYLATE

openFDA Info on Medication

Application Number ANDA078226, ANDA077955, ANDA077073, ANDA078573, ANDA078552, ANDA078021, NDA01978 ... Brand Name AMLODIPINE BESYLATE, AMLODIPINE BESYLATE 2.5 MG, AMLODIPINE BESYLATE 5 MG, AMLOD ... Generic NameAMLODIPINE BESYLATEManufacturers Zydus Pharmaceuticals (USA) Inc., Cipla USA Inc., Torrent Pharmaceuticals Limite ... product_ndc 68382-121, 68382-122, 68382-123, 69097-836, 69097-837, 69097-838, 69097-126, 690 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMLODIPINE BESYLATERXCUI197361, 308135, 308136, 212542, 212549, 212575spl_id b23b048e-91a0-453b-a0ef-64d951fc183e, adb955ec-2369-441f-9db6-0a22bb5b2e7e, dc48 ... spl_set_id fda0739d-b355-478c-acae-8f773a3ec4b3, 0c8d6b2f-3e4a-47a2-80e2-a34dcb337555, 5409 ... Package NDC 68382-121-01, 68382-121-05, 68382-121-16, 68382-121-77, 68382-122-16, 68382-122- ... UNII864V2Q084H

29)

drugcharacterization2medicinalproductASPIRIN 81drugdosagetextUNKdrugdosageformCHEWABLE TABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate06/01/2016drugrecurreadministration3

activesubstance

activesubstancenameASPIRIN

openFDA Info on Medication

Application Numberpart343Brand NameASPIRIN 81, ASPIRIN 325Generic NameASPIRINManufacturersWALGREENS, Amerisource Bergen, Walgreen Companyproduct_ndc0363-6452, 46122-598, 0363-0691Product TypeHUMAN OTC DRUGRouteORALActive IngredientsASPIRINRXCUI308416, 198467spl_id dfa538f5-88a4-f138-e053-2995a90acb92, 5c2dd950-7730-442c-bd2d-37639342858e, 952b ... spl_set_id d71a571e-e2ce-7e0a-e053-2a95a90a53e0, 4491faca-f30b-4eb0-bea9-f518f6b2f095, f7a5 ... Package NDC0363-6452-50, 46122-598-48, 46122-598-87, 0363-0691-12NUIN0000000160, 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

30)

drugcharacterization2medicinalproductCARVEDILOL.drugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate06/01/2016drugrecurreadministration3

activesubstance

activesubstancenameCARVEDILOL

openFDA Info on Medication

Application Number ANDA076373, ANDA078384, ANDA077316, ANDA077614, NDA020297, ANDA078332, ANDA07822 ... Brand NameCARVEDILOL, COREGGeneric NameCARVEDILOLManufacturers Teva Pharmaceuticals USA, Inc., Bayshore Pharmaceuticals LLC, Mylan Pharmaceutic ... product_ndc 0093-0051, 0093-0135, 0093-7295, 0093-7296, 76385-110, 76385-111, 76385-112, 763 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCARVEDILOLRXCUI200031, 200032, 200033, 686924, 212388, 212389, 212390, 686926spl_id a369c0d5-8f93-4b0d-a5a0-8125af1309f7, 6502da81-eb40-40f3-b4f0-c658f6df8829, c2e2 ... spl_set_id 68c275e8-992a-4520-8065-ab6d615d89cc, 33dfcf29-19d6-46ba-b8ed-d59d2226ad07, e502 ... Package NDC 0093-0051-01, 0093-0051-05, 0093-0135-01, 0093-0135-05, 0093-7295-01, 0093-7295- ... NUIN0000000099, N0000009923, N0000009924, N0000175553, N0000175556Mechanism of Action Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenerg ... Established Pharmacologic Classalpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]UNII0K47UL67F2

31)

drugcharacterization2medicinalproductAMITRIPTYLINE HCLdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate06/01/2016drugenddateformat102drugenddate06/01/2016drugrecurreadministration3

activesubstance

activesubstancenameAMITRIPTYLINE

openFDA Info on Medication

32)

drugcharacterization2medicinalproductHYDROCHLOROTHIAZIDE.drugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate06/01/2016drugrecurreadministration3

activesubstance

activesubstancenameHYDROCHLOROTHIAZIDE

openFDA Info on Medication

Application Number ANDA040780, ANDA203018, ANDA040412, ANDA085182, ANDA203561, ANDA078164, ANDA0870 ... Brand NameHYDROCHLOROTHIAZIDEGeneric NameHYDROCHLOROTHIAZIDEManufacturers Aurobindo Pharma Limited, ScieGen Pharmaceuticals, Inc., Solco Healthcare U.S., ... product_ndc 65862-133, 65862-134, 50228-111, 50228-112, 43547-397, 43547-398, 23155-008, 231 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDROCHLOROTHIAZIDERXCUI197770, 310798, 199903, 429503spl_id 857dd673-6ba8-485c-b96b-14291666b852, 5c6f4c6a-cc43-4f4d-bc16-688310c98c72, d8ce ... spl_set_id 01f1f478-5493-439f-9b99-f4f82023781c, 02e96a51-1d56-460c-8c20-3d6f37e0ce46, 60c9 ... Package NDC 65862-133-01, 65862-133-99, 65862-134-01, 65862-134-99, 50228-111-30, 50228-111- ... NUIN0000175359, N0000175419, M0471776Physiologic/Pharmacodynamic EffectIncreased Diuresis [PE]Established Pharmacologic ClassThiazide Diuretic [EPC]Chemical StructureThiazides [CS]UNII0J48LPH2TH

33)

drugcharacterization2medicinalproductSALBUTAMOLdrugdosagetextUNKdrugdosageformINHALERdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate06/01/2016drugrecurreadministration3

activesubstance

activesubstancenameALBUTEROL

34)

drugcharacterization2medicinalproductPARACETAMOLdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate06/01/2016drugrecurreadministration3

activesubstance

activesubstancenameACETAMINOPHEN

openFDA Info on Medication

Application Numberpart343Brand NameL-ORAL PARACETAMOL SYRUP, AC FASTGeneric NamePARACETAMOLManufacturersGLOBAL PHARMA HEALTHCARE PRIVATE LIMITED, GRIMANN SA DE CVproduct_ndc73921-026, 81660-222Product TypeHUMAN OTC DRUGRouteORALActive IngredientsACETAMINOPHENRXCUI307675spl_idad25d998-3fb2-4dff-a5ad-cb40e5009c69, bf001b70-6165-1ec9-e053-2a95a90a1274spl_set_id2d345b38-4b89-4699-bc72-710685bee662, bf001b70-6164-1ec9-e053-2a95a90a1274Package NDC73921-026-04, 81660-222-01UNII362O9ITL9D

35)

drugcharacterization2medicinalproductDILTIAdrugdosagetextUNKdrugdosageformCAPSULEdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate01/12/2015drugenddateformat102drugenddate01/12/2015drugrecurreadministration3

36)

drugcharacterization2medicinalproductMETOLAZONE.drugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate01/12/2015drugenddateformat102drugenddate01/12/2015drugrecurreadministration3

activesubstance

activesubstancenameMETOLAZONE

openFDA Info on Medication

Application Number ANDA076698, ANDA215184, NDA017386, ANDA213827, ANDA076466, ANDA076732, ANDA21325 ... Brand NameMETOLAZONEGeneric NameMETOLAZONEManufacturers Mylan Pharmaceuticals Inc., Advagen Pharma Limited, Lannett Company, Inc., Amici ... product_ndc 0378-6172, 0378-6173, 0378-6174, 72888-052, 72888-053, 72888-054, 0527-2215, 052 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETOLAZONERXCUI197978, 197979, 311671spl_id 295d066f-8bdf-4c33-a1d4-4f768eececc2, ca97b866-6d6c-0293-e053-2a95a90aea3c, b6f3 ... spl_set_id 6639d111-eb21-4997-b964-f5c61bc088f2, 6a9c8415-e389-7a9a-73de-532cf3f57ac5, 7276 ... Package NDC 0378-6172-01, 0378-6173-01, 0378-6174-01, 72888-052-01, 72888-053-01, 72888-054- ... NUIN0000175359, N0000175420Physiologic/Pharmacodynamic EffectIncreased Diuresis [PE]Established Pharmacologic ClassThiazide-like Diuretic [EPC]UNIITZ7V40X7VX

37)

drugcharacterization2medicinalproductESOMEPRAZOLE MAGNESIUM.drugdosagetextUNKdrugdosageformCAPSULEdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate01/12/2015drugenddateformat102drugenddate01/12/2015drugrecurreadministration3

activesubstance

activesubstancenameESOMEPRAZOLE MAGNESIUM

openFDA Info on Medication

Application Number ANDA209647, ANDA209339, ANDA212866, ANDA202784, ANDA212949, ANDA207193, ANDA2120 ... Brand Name ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE, ACID REDUCER, NEXIUM 24HR, NEXIUM 24HR CLE ... Generic Name ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAP ... Manufacturers Amneal Pharmaceuticals LLC, Harris Teeter, INNOVUS PHARMACEUTICALS, INC., Camber ... product_ndc 65162-644, 65162-645, 72036-800, 57483-900, 31722-572, 31722-573, 49035-980, 639 ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteORALActive IngredientsESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM DIHYDRATE, ESOMEPRAZOLERXCUI 606726, 606730, 606728, 861568, 606731, 692576, 692578, 861570, 861576, 861583, ... spl_id 52ee2b44-9a5d-4a13-ac4e-25069b350e03, eef2a256-00d6-499d-8be2-355cbe76374e, 35ef ... spl_set_id d9c8bc29-9b3b-41bc-a802-02cd85c95a11, 38b79d0d-d99e-4011-8a14-a56a3f75d8c3, b3d1 ... Package NDC 65162-645-03, 65162-645-09, 65162-645-50, 65162-645-11, 65162-644-03, 65162-644- ... UNIIR6DXU4WAY9, 36H71644EQ, N3PA6559FTNUIN0000175525, N0000000147, N0000182140Established Pharmacologic ClassProton Pump Inhibitor [EPC]Mechanism of ActionProton Pump Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA]

38)

drugcharacterization2medicinalproductNUCYNTAdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate01/12/2015drugenddateformat102drugenddate01/12/2015drugrecurreadministration3

activesubstance

activesubstancenameTAPENTADOL HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA200533, NDA022304Brand NameNUCYNTA ER, NUCYNTAGeneric NameTAPENTADOL HYDROCHLORIDEManufacturersCollegium Pharmaceutical, Inc.product_ndc 24510-058, 24510-116, 24510-174, 24510-232, 24510-291, 24510-050, 24510-075, 245 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTAPENTADOL HYDROCHLORIDERXCUI 1148797, 1148800, 1148803, 1148807, 1148809, 1149367, 1149370, 1149373, 1149376, ... spl_idcbee26ee-fbdd-4dee-ada8-101ed4a40eed, e5283782-fa09-4c2c-8505-23bc8789e146spl_set_idc3d04d70-0155-4147-9ce4-a3b1fad4b373, 80938c30-9fe3-4c7d-9d9c-5476638cfb2dPackage NDC 24510-058-60, 24510-058-01, 24510-116-60, 24510-116-01, 24510-174-60, 24510-174- ... UNII71204KII53

39)

drugcharacterization2medicinalproductPOTASSIUM AND MAGNESIUM ASPARTATEdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate01/12/2015drugenddateformat102drugenddate01/12/2015drugrecurreadministration3

40)

drugcharacterization2medicinalproductHYDROCODONE BITARTRATE AND ACETAMINOPHENdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate11/10/2013drugenddateformat102drugenddate01/12/2015drugrecurreadministration3

activesubstance

activesubstancenameACETAMINOPHEN\HYDROCODONE BITARTRATE

openFDA Info on Medication

Application Number ANDA211023, ANDA202214, ANDA206245, ANDA203863, ANDA206869, ANDA202991, ANDA2077 ... Brand NameHYDROCODONE BITARTRATE AND ACETAMINOPHEN, LORTABGeneric NameHYDROCODONE BITARTRATE AND ACETAMINOPHENManufacturers Eywa Pharma Inc, Tris Pharma Inc, Novel Laboratories, Inc., Epic Pharma, LLC, Am ... product_ndc 71930-027, 27808-035, 27808-036, 27808-037, 40032-356, 40032-358, 40032-357, 428 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsACETAMINOPHEN, HYDROCODONE BITARTRATERXCUI856940, 856999, 857002, 857005, 856987, 856980, 856992, 1044427, 857391, 1442445spl_id 6b16103c-b56a-461d-9875-b7eeb31411f6, 8ea12d79-1c1f-4c5e-a611-475226dd0285, 102f ... spl_set_id adb37532-aa19-48a2-95a1-8c92a6ce8651, d4caec6d-4af2-4f1c-9add-c0c948b83b16, 7a89 ... Package NDC 71930-027-43, 27808-035-01, 27808-035-02, 27808-035-03, 27808-036-01, 27808-036- ... UNII362O9ITL9D, NO70W886KK

41)

drugcharacterization2medicinalproductFOLIC ACID.drugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate01/01/2001drugrecurreadministration3

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

42)

drugcharacterization2medicinalproductMIRALAXdrugdosagetextUNKdrugdosageformPOWDERdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate30/11/2000drugrecurreadministration3

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

43)

drugcharacterization2medicinalproductDIPHENHYDRAMINE HYDROCHLORIDE.drugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate06/01/2016drugrecurreadministration3

activesubstance

activesubstancenameDIPHENHYDRAMINE HYDROCHLORIDE

openFDA Info on Medication

Application Number part338, part341, part348, ANDA040498, part336, ANDA080817, ANDA205723, ANDA0915 ... Brand Name UP AND UP NIGHTTIME SLEEP AID, DIPHENHYDRAMINE HYDROCHLORIDE, BENADRYL ULTRA TAB ... Generic NameDIPHENHYDRAMINE HYDROCHLORIDEManufacturers Target Corporation, Epic Pharma, LLC, JC World Bell Wholesale Co., Inc., Spirit ... product_ndc 11673-186, 42806-649, 50269-226, 68210-1280, 41250-379, 53943-505, 53943-191, 66 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUS, TOPICALActive IngredientsDIPHENHYDRAMINE HYDROCHLORIDERXCUI 1248354, 1020477, 1049630, 1049632, 1049906, 1049909, 1789740, 1092466, 1248356, ... spl_id 5f5e1563-73fa-4066-9c7f-9fa04aca648f, 4884641f-c4af-4148-89c1-0e29c6ec6e5e, 746d ... spl_set_id 0ab5a374-d565-4385-bee3-538a8f09b19e, 15437a72-24e5-4ef2-b1ea-8d8c0acbcd4c, 1763 ... Package NDC 11673-186-40, 42806-649-10, 50269-226-54, 68210-1280-1, 68210-1280-0, 41250-379- ... UNIITC2D6JAD40, 362O9ITL9D, NBZ3QY004S

44)

drugcharacterization2medicinalproductCETIRIZINE HCLdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate06/01/2016drugrecurreadministration3

activesubstance

activesubstancenameCETIRIZINE HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA204226, ANDA213105, ANDA209274, NDA022429, ANDA090474, ANDA078780, ANDA20723 ... Brand Name HEALTH MART CHILDRENS ALL DAY ALLERGY, ALL DAY ALLERGY, CHILDRENS CETIRIZINE HYD ... Generic NameCETIRIZINE HCLManufacturers Strategic Sourcing Services LLC, WALMART INC., Major Pharmaceuticals, H E B, P & ... product_ndc 62011-0323, 79903-084, 0904-6765, 37808-564, 59726-806, 46122-613, 63868-433, 11 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsCETIRIZINE HYDROCHLORIDERXCUI1014673, 1014675, 1014678, 1087169, 1482533, 1020017, 1549337spl_id ddeda4a6-126d-4938-ad67-1b4bc75927f2, d854f3c6-f243-4ace-8f82-5c57de814716, 6a59 ... spl_set_id a947dbe8-aa58-447a-8b09-a38e0c87aee7, c8016d34-aa72-4857-b5ed-5476948b386a, db29 ... Package NDC 62011-0323-1, 79903-084-25, 0904-6765-20, 37808-564-25, 59726-806-05, 59726-806- ... UNII64O047KTOA

45)

drugcharacterization2medicinalproductCYMBALTAdrugdosagetextUNKdrugdosageformCAPSULEdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate06/01/2016drugrecurreadministration3

activesubstance

activesubstancenameDULOXETINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021427Brand NameCYMBALTAGeneric NameDULOXETINE HYDROCHLORIDEManufacturersEli Lilly and Companyproduct_ndc0002-3235, 0002-3240, 0002-3270Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDULOXETINE HYDROCHLORIDERXCUI596926, 596928, 596930, 596932, 596934, 615186spl_id892f05de-dd11-4ae3-9a85-ce9cfcbeaaccspl_set_id2f7d4d67-10c1-4bf4-a7f2-c185fbad64baPackage NDC0002-3235-60, 0002-3240-30, 0002-3240-90, 0002-3270-30, 0002-3270-04UNII9044SC542W

46)

drugcharacterization2medicinalproductNIASPANdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate06/01/2016drugenddateformat102drugenddate06/01/2016drugrecurreadministration3

activesubstance

activesubstancenameNIACIN

openFDA Info on Medication

Application NumberNDA020381Brand NameNIASPANGeneric NameNIACINManufacturersAbbVie Inc.product_ndc0074-3265, 0074-3074, 0074-3079, 0074-3080, 0074-3274, 0074-3275Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsNIACINRXCUI1098134, 1098135, 1098141, 1098142, 1098143, 1098144spl_id4d0c980a-6f82-417b-ad85-ff1561bb1f4bspl_set_id35433c7b-556c-49a0-bfb5-0d498359925bPackage NDC 0074-3074-90, 0074-3074-03, 0074-3074-07, 0074-3074-30, 0074-3079-90, 0074-3079- ... NUIN0000175594, M0014839Established Pharmacologic ClassNicotinic Acid [EPC]Chemical StructureNicotinic Acids [CS]UNII2679MF687A

47)

drugcharacterization2medicinalproductPRIMIDONE.drugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate06/01/2016drugrecurreadministration3

activesubstance

activesubstancenamePRIMIDONE

openFDA Info on Medication

Application NumberANDA084903, ANDA083551, ANDA040586, NDA009170, ANDA040866, ANDA040862Brand NamePRIMIDONE, MYSOLINEGeneric NamePRIMIDONEManufacturers Lannett Company, Inc., Actavis Pharma, Inc., Oxford Pharmaceuticals, LLC, Bausch ... product_ndc 0527-1231, 0527-1301, 0591-5321, 69584-684, 69584-685, 66490-690, 66490-691, 422 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPRIMIDONERXCUI96304, 198150, 201747, 207478spl_id 82bb8d14-13f7-48e2-b3a6-f193f71fac65, ea3729e4-be9a-454f-aca7-7b13869a6076, 86b0 ... spl_set_id a1a817f7-c190-4825-94eb-442f477187e3, ae0fa704-818e-4423-8e3a-6cc3390cdd7d, 4390 ... Package NDC 0527-1301-01, 0527-1301-05, 0527-1301-10, 0527-1231-01, 0527-1231-05, 0527-1231- ... NUIN0000175753, N0000008486Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII13AFD7670Q

48)

drugcharacterization2medicinalproductALEVEdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate01/12/2015drugrecurreadministration3

activesubstance

activesubstancenameNAPROXEN SODIUM

openFDA Info on Medication

Application NumberNDA020204, NDA021920Brand Name ALEVE GELCAPS, ALEVE CAPLETS - EASY OPEN ARTHRITIS CAP, ALEVE, ALEVE EASY OPEN A ... Generic NameNAPROXEN SODIUM, NAPROXEN SODIUM TABLETManufacturersBayer HealthCare LLC., Lil' Drug Store Products, Inc, Mechanical Servants LLCproduct_ndc 0280-6020, 0280-6050, 0280-6070, 0280-6010, 66715-9702, 29485-1013, 29485-6751, ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsNAPROXEN SODIUMRXCUI849574, 849728, 1112231, 1112233spl_id c688d37e-9e82-4599-e053-2a95a90a1916, c9ef15ce-9dd0-f536-e053-2995a90acdf8, bff5 ... spl_set_id 0ad8bbb9-dd5f-4273-b085-ee3e5ed22613, 94f09ef7-0695-4499-83c1-95f1e42baf98, acea ... Package NDC 0280-6020-20, 0280-6020-40, 0280-6020-80, 0280-6020-16, 0280-6050-50, 0280-6050- ... UNII9TN87S3A3C

49)

drugcharacterization2medicinalproductLISINOPRIL.drugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate02/06/2015drugrecurreadministration3

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

50)

drugcharacterization2medicinalproductVITAMIN B12drugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugrecurreadministration3

activesubstance

activesubstancenameCYANOCOBALAMIN

summary

narrativeincludeclinicalCASE EVENT DATE: 2013