Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID12666175primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate09/11/2016reporttype1serious2receivedateformat102Date Received18/08/2016receiptdateformat102Date Last Updated18/08/2016fulfillexpeditecriteria2companynumbUS-JAZZ-2016-US-005765duplicate1

Report Duplicate

duplicatesourceJAZZduplicatenumbUS-JAZZ-2016-US-005765

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

SexFemale

Contents

Reaction

1)

reactionmeddraversionpt19.1ReactionFatigueOutcomeUnknown

2)

reactionmeddraversionpt19.1ReactionMigraineOutcomeUnknown

3)

reactionmeddraversionpt19.1ReactionUnevaluable eventOutcomeUnknown

4)

reactionmeddraversionpt19.1ReactionDyspnoeaOutcomeUnknown

5)

reactionmeddraversionpt19.1ReactionNervousnessOutcomeUnknown

6)

reactionmeddraversionpt19.1ReactionProduct taste abnormalOutcomeUnknown

7)

reactionmeddraversionpt19.1ReactionSinusitisOutcomeUnknown

8)

reactionmeddraversionpt19.1ReactionDry eyeOutcomeUnknown

9)

reactionmeddraversionpt19.1ReactionCoughOutcomeUnknown

10)

reactionmeddraversionpt19.1ReactionImmune system disorderOutcomeUnknown

11)

reactionmeddraversionpt19.1ReactionEmotional disorderOutcomeUnknown

12)

reactionmeddraversionpt19.1ReactionDiarrhoeaOutcomeUnknown

13)

reactionmeddraversionpt19.1ReactionFeeling abnormalOutcomeUnknown

14)

reactionmeddraversionpt19.1ReactionDrug intoleranceOutcomeUnknown

15)

reactionmeddraversionpt19.1ReactionRespiratory tract infectionOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugstructuredosagenumb4.5drugstructuredosageunit002drugdosagetext4.5 G, BIDdrugdosageformORAL SOLUTIONdrugadministrationroute048drugstartdateformat610drugstartdate/01/2016drugenddateformat602drugenddate//2016actiondrug5drugadditional3

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

2)

drugcharacterization2medicinalproductCAMBIAdrugrecurreadministration3

activesubstance

activesubstancenameDICLOFENAC POTASSIUM

openFDA Info on Medication

Application NumberNDA022165Brand NameCAMBIAGeneric NameDICLOFENAC POTASSIUMManufacturersAssertio Therapeutics, Inc.product_ndc13913-011, 13913-012Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDICLOFENAC POTASSIUMRXCUI859063, 859066spl_id90212a85-4b76-4a51-a22b-15016a491238, e8123abd-304e-4001-8ff1-01f5619ba30fspl_set_idc5856c21-f322-11e3-ac10-0800200c9a66, d249ced1-4ca0-4f57-adcb-23440f58f659Package NDC13913-011-01, 13913-011-19, 13913-012-01, 13913-012-03, 13913-012-02UNIIL4D5UA6CB4

3)

drugcharacterization2medicinalproductMETHYLERGONOVINE MALEATE.drugrecurreadministration3

activesubstance

activesubstancenameMETHYLERGONOVINE MALEATE

openFDA Info on Medication

Application Number ANDA090193, ANDA211919, ANDA040889, ANDA091577, ANDA211483, ANDA210424, ANDA2114 ... Brand NameMETHYLERGONOVINE MALEATE, METHERGINEGeneric NameMETHYLERGONOVINE MALEATE, METHYLERGONOVINEManufacturers American Regent, Inc., Rising Pharma Holdings, Inc., Pharmacist Pharmaceutical, ... product_ndc 0517-0740, 16571-735, 63704-004, 43386-140, 51991-144, 40032-140, 69238-1605, 27 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, ORALActive IngredientsMETHYLERGONOVINE MALEATERXCUI996828, 996824, 996826spl_id fd646b72-2c28-406e-91a1-e1026551fc2d, dba544da-0b98-4e4a-a71f-2e7fe64ad1b2, 22f7 ... spl_set_id a9a3079e-b62b-4858-920e-d8f5cb38481e, 465b292b-0e0e-4a55-894e-90234efe2a12, 17ee ... Package NDC 0517-0740-01, 0517-0740-20, 16571-735-17, 16571-735-21, 16571-735-28, 16571-735- ... UNIIIR84JPZ1RK

4)

drugcharacterization2medicinalproductPHENERGANdrugrecurreadministration3

activesubstance

activesubstancenamePROMETHAZINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA083312Brand NamePHENERGANGeneric NamePROMETHAZINE HYDROCHLORIDEManufacturersWest-Ward Pharmaceuticals Corp., Hikma Pharmaceuticals USA Inc.product_ndc0641-6082, 0641-6083, 0641-6084, 0641-6085Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUSActive IngredientsPROMETHAZINE HYDROCHLORIDERXCUI992460, 992462, 992858, 992876spl_ided9c544d-8e03-45cb-8509-b71b630d764d, bc2d8f01-1268-4bb2-8db9-793866d32782spl_set_id6f7e47cc-f823-4336-8107-f980e3049617, 481866da-a712-48a5-853f-8e84aacaab6dPackage NDC 0641-6082-01, 0641-6082-25, 0641-6083-01, 0641-6083-25, 0641-6084-01, 0641-6084- ... UNIIR61ZEH7I1I

5)

drugcharacterization2medicinalproductRESTASISdrugrecurreadministration3

activesubstance

activesubstancenameCYCLOSPORINE

openFDA Info on Medication

Application NumberNDA050790Brand NameRESTASISGeneric NameCYCLOSPORINEManufacturersAllergan, Inc.product_ndc0023-9163Product TypeHUMAN PRESCRIPTION DRUGRouteOPHTHALMICActive IngredientsCYCLOSPORINERXCUI2572292, 2572293spl_id554c342b-15e5-4910-938f-d1c38ff0e516spl_set_id8e24af2b-bc1c-4849-94f2-6df950cdca89Package NDC0023-9163-12, 0023-9163-30, 0023-9163-60NUIN0000175457, N0000175458, N0000182141, N0000185503Established Pharmacologic ClassCalcineurin Inhibitor Immunosuppressant [EPC]Mechanism of Action Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprote ... UNII83HN0GTJ6D

6)

drugcharacterization2medicinalproductTIGANdrugrecurreadministration3

activesubstance

activesubstancenameTRIMETHOBENZAMIDE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA017530Brand NameTIGANGeneric NameTRIMETHOBENZAMIDE HYDROCHLORIDEManufacturersPar Pharmaceutical, Inc.product_ndc42023-119, 42023-118Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULARActive IngredientsTRIMETHOBENZAMIDE HYDROCHLORIDERXCUI860749, 860751, 1726680, 1726682spl_id9c9f34d9-8879-4f6c-a106-427b7f10c085spl_set_id7da90678-b229-4ad6-9193-2b8a3e9ba695Package NDC42023-118-01, 42023-119-25UNIIWDQ5P1SX7Q

7)

drugcharacterization2medicinalproductTRAZODONE HYDROCHLORIDE.drugrecurreadministration3

activesubstance

activesubstancenameTRAZODONE HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA071523, ANDA071524, ANDA071525, ANDA071258, ANDA071196, ANDA205253, ANDA0731 ... Brand NameTRAZODONE HYDROCHLORIDEGeneric NameTRAZODONE HYDROCHLORIDEManufacturers Teva Pharmaceuticals USA, Inc., Apotex Corp, Cadila Healthcare Limited, Zydus Ph ... product_ndc 50111-433, 50111-560, 50111-561, 50111-450, 50111-434, 60505-2653, 60505-2654, 6 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTRAZODONE HYDROCHLORIDERXCUI856364, 856373, 856377, 856369spl_id e1890c37-eb69-4224-a5ea-b02390d4eb95, 782dc7ff-8f29-6639-29f2-061d2b1e72be, b636 ... spl_set_id 4006d439-e2de-4590-82e9-fc9d56e3ec1b, 71961ab1-951d-1493-f76c-2ff25cca2a85, 9c4d ... Package NDC 50111-560-01, 50111-560-02, 50111-560-03, 50111-561-01, 50111-561-02, 50111-561- ... UNII6E8ZO8LRNM

8)

drugcharacterization2medicinalproductTUSSIONEX PENNKINETICdrugrecurreadministration3

activesubstance

activesubstancenameCHLORPHENIRAMINE\HYDROCODONE

9)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugstructuredosagenumb2.25drugstructuredosageunit002drugdosagetext2.25 G, BIDdrugdosageformORAL SOLUTIONdrugadministrationroute048drugindicationNARCOLEPSYdrugstartdateformat610drugstartdate/07/2012drugenddateformat610drugenddate/08/2012actiondrug5drugadditional3

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

10)

drugcharacterization2medicinalproductDIFLUCANdrugrecurreadministration3

activesubstance

activesubstancenameFLUCONAZOLE

openFDA Info on Medication

Application NumberNDA019949, NDA020090Brand NameDIFLUCANGeneric NameFLUCONAZOLEManufacturersRoerigproduct_ndc0049-3410, 0049-3420, 0049-3500, 0049-3430, 0049-3440, 0049-3450Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFLUCONAZOLERXCUI 197698, 197699, 197700, 197701, 201900, 201901, 207106, 207107, 207108, 207112, ... spl_id54878b4c-2fee-4d89-8dd0-89fa04489864spl_set_idf694c617-3383-416c-91b6-b94fda371204Package NDC 0049-3410-30, 0049-3420-30, 0049-3420-41, 0049-3500-79, 0049-3430-30, 0049-3430- ... NUIN0000175487, M0002083, N0000182140, N0000182141, N0000185504Established Pharmacologic ClassAzole Antifungal [EPC]Chemical StructureAzoles [CS]Mechanism of Action Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Cyt ... UNII8VZV102JFY

11)

drugcharacterization2medicinalproductCYPROHEPTADINE HCLdrugrecurreadministration3

activesubstance

activesubstancenameCYPROHEPTADINE HYDROCHLORIDE

12)

drugcharacterization2medicinalproductKLONOPINdrugrecurreadministration3

activesubstance

activesubstancenameCLONAZEPAM

openFDA Info on Medication

Application NumberNDA017533Brand NameKLONOPINGeneric NameCLONAZEPAMManufacturersH2-Pharma, LLC, Genentech, Inc.product_ndc61269-605, 61269-610, 61269-620, 0004-0058, 0004-0068, 0004-0098Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONAZEPAMRXCUI197527, 197528, 197529, 206157, 206159, 206160spl_id65d5607d-3926-4b60-97dc-18509af3f271, 0d423291-6115-4522-88db-dcd1096bd432spl_set_idcfa0d79a-843c-4b88-95a1-e9511d649ca1, 542f22e8-dad2-47a8-93b6-30936715d73bPackage NDC 61269-605-10, 61269-610-10, 61269-620-10, 0004-0068-01, 0004-0058-01, 0004-0098- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII5PE9FDE8GB

13)

drugcharacterization2medicinalproductTIMOLOL.drugrecurreadministration3

activesubstance

activesubstancenameTIMOLOL

openFDA Info on Medication

Application NumberANDA212291, NDA020439Brand NameTIMOLOL MALEATE, BETIMOLGeneric NameTIMOLOLManufacturersAkornproduct_ndc17478-189, 76478-001, 76478-002Product TypeHUMAN PRESCRIPTION DRUGRouteOPHTHALMICActive IngredientsTIMOLOLRXCUI1922894, 208560, 1923428, 1992303, 1992305spl_id54f834c6-e4fc-477a-aeb8-426de2590232, 1148d491-87d2-4423-8486-4e5355e968edspl_set_idb969bb47-6b4a-46ee-93cc-52faee4369c4, 3d7acd55-33b1-4a24-99ae-01f87b0dca1fPackage NDC 17478-189-24, 76478-001-05, 76478-001-10, 76478-001-15, 76478-002-12, 76478-002- ... UNII817W3C6175

14)

drugcharacterization2medicinalproductVALIUMdrugrecurreadministration3

activesubstance

activesubstancenameDIAZEPAM

openFDA Info on Medication

Application NumberNDA013263Brand NameVALIUMGeneric NameDIAZEPAMManufacturersRoche Laboratories Inc., Waylis Therapuetics LLCproduct_ndc0140-0004, 0140-0005, 0140-0006, 80725-004, 80725-005, 80725-006Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDIAZEPAMRXCUI104699, 104700, 104701, 197589, 197590, 197591spl_idc0054f7c-9c38-4ac8-ae8f-5e6427e1fd14, dc250376-39ef-2207-e053-2a95a90a4901spl_set_id554baee5-b171-4452-a50a-41a0946f956c, 260e2041-2bb3-482f-850e-b5d47a7bdbe6Package NDC 0140-0004-01, 0140-0005-01, 0140-0005-14, 0140-0006-01, 0140-0006-14, 80725-004- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIQ3JTX2Q7TU

15)

drugcharacterization2medicinalproductWELLBUTRINdrugrecurreadministration3

activesubstance

activesubstancenameBUPROPION HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021515, NDA020358Brand NameWELLBUTRIN XL, WELLBUTRIN SRGeneric NameBUPROPION HYDROCHLORIDEManufacturersBausch Health US LLC, GlaxoSmithKline LLCproduct_ndc0187-0730, 0187-0731, 0173-0135, 0173-0947, 0173-0722Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsBUPROPION HYDROCHLORIDERXCUI993541, 993545, 993557, 993564, 993503, 993511, 993518, 993528, 993536, 993537spl_id63046e0c-233f-4dc1-b3eb-f9d27872bd25, eb423af3-e5f0-4c6c-a698-ff0ef35edcabspl_set_ida435da9d-f6e8-4ddc-897d-8cd2bf777b21, cbc8c074-f080-4489-a5ae-207b5fadeba3Package NDC 0187-0730-30, 0187-0730-90, 0187-0730-07, 0187-0731-30, 0187-0731-07, 0173-0947- ... UNIIZG7E5POY8O

16)

drugcharacterization2medicinalproductZOLOFTdrugrecurreadministration3

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

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_idca266f27-bd08-49ba-8d79-a6dba8699bd9spl_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

17)

drugcharacterization2medicinalproductXOPENEX HFAdrugrecurreadministration3

activesubstance

activesubstancenameLEVALBUTEROL TARTRATE

openFDA Info on Medication

Application NumberNDA021730Brand NameXOPENEX HFAGeneric NameLEVALBUTEROL TARTRATEManufacturersSunovion Pharmaceuticals Inc.product_ndc63402-510Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLEVALBUTEROL TARTRATERXCUI745791, 746466spl_idbdfdcf19-9165-4b49-9cf2-505e7c107e57spl_set_id218ab3f0-4d1e-4c33-a7e8-27807f029d83Package NDC63402-510-01UNIIADS4I3E22M

18)

drugcharacterization2medicinalproductSINGULAIRdrugrecurreadministration3

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

19)

drugcharacterization2medicinalproductAMBIENdrugrecurreadministration3

activesubstance

activesubstancenameZOLPIDEM TARTRATE

openFDA Info on Medication

Application NumberNDA021774, NDA019908Brand NameAMBIEN CR, AMBIENGeneric NameZOLPIDEM TARTRATEManufacturerssanofi-aventis U.S. LLCproduct_ndc0024-5501, 0024-5521, 0024-5401, 0024-5421Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsZOLPIDEM TARTRATERXCUI854880, 854882, 854894, 854896, 854873, 854875, 854876, 854878spl_id8138a0a9-168c-46d2-b13e-e7e84f27eaee, c8f05d12-bc35-43cb-8b65-588bec02c73dspl_set_id404c858c-89ac-4c9d-8a96-8702a28e6e76, c36cadf4-65a4-4466-b409-c82020b42452Package NDC 0024-5501-31, 0024-5501-10, 0024-5521-31, 0024-5521-50, 0024-5521-10, 0024-5401- ... UNIIWY6W63843K

20)

drugcharacterization2medicinalproductLAMICTALdrugrecurreadministration3

activesubstance

activesubstancenameLAMOTRIGINE

openFDA Info on Medication

Application NumberNDA020764, NDA020241, NDA022251, NDA022115Brand NameLAMICTAL, LAMICTAL ODT, LAMICTAL XRGeneric NameLAMOTRIGINEManufacturersGlaxoSmithKline LLCproduct_ndc 0173-0526, 0173-0633, 0173-0642, 0173-0643, 0173-0644, 0173-0699, 0173-0527, 017 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLAMOTRIGINERXCUI 103968, 105018, 105019, 108782, 198427, 198428, 198429, 198430, 201239, 201240, ... spl_id836ca780-3d75-4304-aded-c36bf096205d, e77aba1a-7ae8-42ef-b6d7-4db47796bd0espl_set_idd7e3572d-56fe-4727-2bb4-013ccca22678, 3e2c9a35-6a39-41d7-ad84-3c0bb8894b09Package NDC 0173-0633-02, 0173-0633-10, 0173-0642-55, 0173-0643-60, 0173-0644-60, 0173-0699- ... NUIN0000175753, N0000008486, N0000175751, N0000187061, N0000000191Established Pharmacologic ClassAnti-epileptic Agent [EPC], Mood Stabilizer [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]Mechanism of Action Organic Cation Transporter 2 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor ... UNIIU3H27498KS

21)

drugcharacterization2medicinalproductNEURPATH Bdrugrecurreadministration3

22)

drugcharacterization2medicinalproductPROTONIXdrugrecurreadministration3

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

23)

drugcharacterization2medicinalproductXOPENEXdrugrecurreadministration3

activesubstance

activesubstancenameLEVALBUTEROL HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020837Brand NameXOPENEXGeneric NameLEVALBUTEROL HYDROCHLORIDEManufacturersAkornproduct_ndc17478-172, 17478-173, 17478-174, 17478-171Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsLEVALBUTEROL HYDROCHLORIDERXCUI242754, 261136, 311286, 349590, 352132, 833470, 1855389, 1855391spl_id1d4b8d31-acf9-4345-9794-ee040fd63231, 438ae704-953d-4725-9693-95f4ea3476despl_set_id7e2644e6-36c5-4988-8e52-bec90e2cd2f0, 0c47c47d-45f7-4eb4-b1f8-7d6c633a1f69Package NDC 17478-172-12, 17478-172-24, 17478-173-12, 17478-173-24, 17478-174-12, 17478-174- ... UNIIWDQ1526QJM

24)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugdosagetextDOSE ADJUSTMENTdrugdosageformORAL SOLUTIONdrugadministrationroute048actiondrug5drugadditional3

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

25)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugdosagetext3GM ONCE NIGHTLY EVERY OTHER NIGHTdrugdosageformORAL SOLUTIONactiondrug5drugadditional3

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

26)

drugcharacterization2medicinalproductEFFEXORdrugrecurreadministration3

activesubstance

activesubstancenameVENLAFAXINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA020699Brand NameEFFEXOR XRGeneric NameVENLAFAXINE HYDROCHLORIDEManufacturersWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.product_ndc0008-0833, 0008-0837, 0008-0836Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsVENLAFAXINE HYDROCHLORIDERXCUI313581, 313583, 313585, 729929, 729931, 729932spl_id932efe9b-6185-488f-ac7b-5e12203a7821spl_set_id53c3e7ac-1852-4d70-d2b6-4fca819acf26Package NDC 0008-0837-20, 0008-0837-21, 0008-0837-22, 0008-0837-02, 0008-0837-03, 0008-0833- ... UNII7D7RX5A8MO

27)

drugcharacterization2medicinalproductLYRICAdrugrecurreadministration3

activesubstance

activesubstancenamePREGABALIN

openFDA Info on Medication

Application NumberNDA021446, NDA022488Brand NameLYRICAGeneric NamePREGABALINManufacturersParke-Davis Div of Pfizer Inc, U.S. Pharmaceuticalsproduct_ndc 0071-1012, 0071-1013, 0071-1014, 0071-1015, 0071-1016, 0071-1017, 0071-1019, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREGABALINRXCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127, 607018, 607020, ... spl_idb9b1285a-2cb3-4789-8b0e-8d5e1b253534, bfdec19d-6a54-449c-95b4-908d28e5369aspl_set_id60185c88-ecfd-46f9-adb9-b97c6b00a553, ce1a4b9d-3127-4416-8bf2-fee5899fc0baPackage NDC 0071-1012-68, 0071-1013-41, 0071-1013-68, 0071-1014-41, 0071-1014-68, 0071-1015- ... UNII55JG375S6M

28)

drugcharacterization2medicinalproductMIGRANALdrugrecurreadministration3

activesubstance

activesubstancenameDIHYDROERGOTAMINE MESYLATE

openFDA Info on Medication

Application NumberNDA020148Brand NameMIGRANALGeneric NameDIHYDROERGOTAMINE MESYLATEManufacturersBausch Health US, LLCproduct_ndc0187-0245Product TypeHUMAN PRESCRIPTION DRUGRouteNASALActive IngredientsDIHYDROERGOTAMINE MESYLATERXCUI861668, 861670spl_idc903aca4-0f39-4330-8fef-10a6e62de026spl_set_ida24befa8-b952-48ac-942a-379585250782Package NDC0187-0245-03, 0187-0245-04, 0187-0245-01UNII81AXN7R2QT

29)

drugcharacterization2medicinalproductSONATAdrugrecurreadministration3

activesubstance

activesubstancenameZALEPLON

30)

drugcharacterization2medicinalproductTRILEPTALdrugrecurreadministration3

activesubstance

activesubstancenameOXCARBAZEPINE

openFDA Info on Medication

Application NumberNDA021014, NDA021285Brand NameTRILEPTALGeneric NameOXCARBAZEPINEManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0337, 0078-0456, 0078-0457, 0078-0357Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOXCARBAZEPINERXCUI261356, 261360, 262090, 283536, 312136, 312137, 312138, 351992spl_ida131d889-e202-4b56-830b-6cdef9b212d4spl_set_id4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691bPackage NDC 0078-0456-05, 0078-0456-61, 0078-0456-35, 0078-0337-05, 0078-0337-61, 0078-0337- ... NUIN0000175753, N0000008486Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNIIVZI5B1W380

31)

drugcharacterization2medicinalproductVERAPAMILdrugrecurreadministration3

activesubstance

activesubstancenameVERAPAMIL HYDROCHLORIDE

32)

drugcharacterization2medicinalproductAMOXICILLIN.drugrecurreadministration3

activesubstance

activesubstancenameAMOXICILLIN

openFDA Info on Medication

Application Number ANDA065255, ANDA065056, ANDA065271, ANDA065256, ANDA064013, ANDA061926, ANDA0619 ... Brand NameAMOXICILLINGeneric NameAMOXICILLINManufacturers Hikma Pharmaceuticals USA Inc., Teva Pharmaceuticals USA, Inc., NorthStar Rx LLC ... product_ndc 0143-9285, 0093-2263, 0093-2264, 16714-298, 16714-299, 57237-028, 57237-029, 009 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMOXICILLINRXCUI308194, 308192, 308182, 308191, 239191, 308177, 598025, 308189, 313850, 313797spl_id 11f42795-cdea-4c98-a921-2c54e40370ba, 7b44bb9c-2d87-4260-81f1-fea8539749a5, 832f ... spl_set_id c8591c2a-92ef-4432-b19a-bb46063047ee, 20c86622-85b7-4827-a317-57aee79dfe57, 843f ... Package NDC 0143-9285-01, 0143-9285-20, 0093-2263-01, 0093-2264-01, 16714-298-01, 16714-298- ... UNII804826J2HU

33)

drugcharacterization2medicinalproductNUVIGILdrugrecurreadministration3

activesubstance

activesubstancenameARMODAFINIL

openFDA Info on Medication

Application NumberNDA021875Brand NameNUVIGILGeneric NameARMODAFINILManufacturersCephalon, Inc.product_ndc63459-205, 63459-215, 63459-220, 63459-225Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsARMODAFINILRXCUI724859, 724861, 724863, 805659, 805661, 805663, 861960, 861962spl_id45233d0c-09e6-4ee1-a5f6-521f47d6cac1spl_set_idd878aed0-ddbf-8fa1-abf7-d3e480260845Package NDC 63459-205-30, 63459-215-07, 63459-215-35, 63459-215-30, 63459-220-07, 63459-220- ... UNIIV63XWA605I

34)

drugcharacterization2medicinalproductPROVIGILdrugrecurreadministration3

activesubstance

activesubstancenameMODAFINIL

openFDA Info on Medication

Application NumberNDA020717Brand NamePROVIGILGeneric NameMODAFINILManufacturersCephalon, Inc.product_ndc63459-101, 63459-201Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMODAFINILRXCUI205324, 213471, 226426, 260218spl_id22321588-2125-4ed0-b9ff-87a8513bf271spl_set_ide16c26ad-7bc2-d155-3a5d-da83ad6492c8Package NDC63459-101-01, 63459-101-30, 63459-201-01, 63459-201-30NUIN0000175729, N0000175651, N0000175769Physiologic/Pharmacodynamic EffectCentral Nervous System Stimulation [PE], Increased Sympathetic Activity [PE]Established Pharmacologic ClassSympathomimetic-like Agent [EPC]UNIIR3UK8X3U3D

35)

drugcharacterization2medicinalproductZOMIGdrugrecurreadministration3

activesubstance

activesubstancenameZOLMITRIPTAN

openFDA Info on Medication

Application NumberNDA021450, NDA020768Brand NameZOMIGGeneric NameZOLMITRIPTANManufacturersAmneal Pharmaceuticalsproduct_ndc64896-681, 64896-682, 64896-671, 64896-672, 64896-691, 64896-692Product TypeHUMAN PRESCRIPTION DRUGRouteNASAL, ORALActive IngredientsZOLMITRIPTANRXCUI 402000, 402169, 1483677, 1483679, 153353, 200193, 200194, 213167, 284201, 351134 ... spl_idb9b72b8d-15e8-4b78-bfd4-793bebf3b244, b8e6d504-1c3e-4da5-a835-24622cb8e8f5spl_set_id84b51cb9-83f3-4a49-7fa3-1adc0f963658, df93b636-103f-4fb5-26b6-50f639e29b1dPackage NDC 64896-681-51, 64896-681-30, 64896-682-51, 64896-682-30, 64896-671-51, 64896-671- ... NUIN0000175763, N0000175764, N0000175765Mechanism of ActionSerotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA]Established Pharmacologic ClassSerotonin-1b and Serotonin-1d Receptor Agonist [EPC]UNII2FS66TH3YW

36)

drugcharacterization2medicinalproductABILIFYdrugrecurreadministration3

activesubstance

activesubstancenameARIPIPRAZOLE

openFDA Info on Medication

Application NumberNDA021436Brand NameABILIFYGeneric NameARIPIPRAZOLEManufacturersOtsuka America Pharmaceutical, Inc.product_ndc 59148-006, 59148-007, 59148-008, 59148-009, 59148-010, 59148-011, 59148-013, 591 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsARIPIPRAZOLERXCUI 349490, 349545, 349547, 349553, 352307, 352308, 352309, 352310, 402131, 404602, ... spl_idfa6e0346-2760-404e-bfea-23fc6403cdffspl_set_idc040bd1d-45b7-49f2-93ea-aed7220b30acPackage NDC 59148-006-13, 59148-006-92, 59148-007-13, 59148-007-35, 59148-007-94, 59148-008- ... NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNII82VFR53I78

37)

drugcharacterization2medicinalproductADDERALLdrugrecurreadministration3

activesubstance

activesubstancename AMPHETAMINE ASPARTATE\AMPHETAMINE SULFATE\DEXTROAMPHETAMINE SACCHARATE\DEXTROAMP ...

openFDA Info on Medication

Application NumberANDA040422, NDA021303Brand NameADDERALL, ADDERALL XRGeneric Name DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, ... ManufacturersTeva Pharmaceuticals USA, Inc., Takeda Pharmaceuticals America, Inc.product_ndc 57844-105, 57844-117, 57844-110, 57844-112, 57844-115, 57844-120, 57844-130, 540 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive Ingredients AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHA ... RXCUI 541363, 541365, 541878, 541879, 541892, 541894, 577957, 577960, 577961, 577962, ... spl_id12989a25-f31c-4550-9b5d-f354f7f0af45, e3546445-6a4a-46a2-af40-026167005259spl_set_idf22635fe-821d-4cde-aa12-419f8b53db81, aff45863-ffe1-4d4f-8acf-c7081512a6c0Package NDC 57844-105-01, 57844-117-01, 57844-110-01, 57844-112-01, 57844-115-01, 57844-120- ... UNIIJJ768O327N, O1ZPV620O4, G83415V073, 6DPV8NK46S

38)

drugcharacterization2medicinalproductAZELASTINEdrugrecurreadministration3

activesubstance

activesubstancenameAZELASTINE

openFDA Info on Medication

Application NumberANDA204660, ANDA208156Brand NameAZELASTINE HYDROCHLORIDE, AZELASTINEGeneric NameAZELASTINEManufacturersAmneal Pharmaceuticals LLC, AvKARE, Ascend Laboratories, LLCproduct_ndc65162-676, 42291-094, 67877-477Product TypeHUMAN PRESCRIPTION DRUGRouteNASALActive IngredientsAZELASTINE HYDROCHLORIDERXCUI1797867spl_id 7a7bb50d-101a-4ea6-9422-b68ca6eba138, bca768cc-4271-3cd0-e053-2a95a90a8891, 7b6e ... spl_set_id 7902605c-944a-4d7e-a7d4-eb4a71bcacdb, bca75501-4140-4d77-e053-2a95a90a019f, 77b2 ... Package NDC65162-676-84, 42291-094-30, 67877-477-50UNII0L591QR10I

39)

drugcharacterization2medicinalproductBOTOXdrugrecurreadministration3

activesubstance

activesubstancenameONABOTULINUMTOXINA

openFDA Info on Medication

Application NumberBLA103000Brand NameBOTOXGeneric NameONABOTULINUMTOXINAManufacturersAllergan, Inc.product_ndc0023-1145, 0023-3921Product TypeHUMAN PRESCRIPTION DRUGRouteINTRADERMAL, INTRAMUSCULARActive IngredientsBOTULINUM TOXIN TYPE ARXCUI860192, 860195, 897366, 897368spl_id5cbbcda3-4d1a-4a0c-b6a1-f5328793f173spl_set_id33d066a9-34ff-4a1a-b38b-d10983df3300Package NDC0023-1145-01, 0023-1145-02, 0023-3921-02, 0023-3921-03NUIN0000175771, N0000193962, N0000175731, N0000175770Established Pharmacologic ClassAcetylcholine Release Inhibitor [EPC], Neuromuscular Blocker [EPC]Physiologic/Pharmacodynamic EffectNeuromuscular Blockade [PE]Mechanism of ActionAcetylcholine Release Inhibitors [MoA]UNIIE211KPY694

40)

drugcharacterization2medicinalproductCONCERTAdrugrecurreadministration3

activesubstance

activesubstancenameMETHYLPHENIDATE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021121Brand NameCONCERTAGeneric NameMETHYLPHENIDATE HYDROCHLORIDEManufacturersJanssen Pharmaceuticals, Inc.product_ndc50458-585, 50458-588, 50458-586, 50458-587Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETHYLPHENIDATE HYDROCHLORIDERXCUI1091155, 1091157, 1091170, 1091172, 1091185, 1091187, 1091210, 1091212spl_ide07a69ac-3422-4eac-8a0e-bd720a91d991spl_set_id1a88218c-5b18-4220-8f56-526de1a276cdPackage NDC50458-585-01, 50458-588-01, 50458-586-01, 50458-587-01UNII4B3SC438HI

41)

drugcharacterization2medicinalproductDOXEPINdrugrecurreadministration3

activesubstance

activesubstancenameDOXEPIN

openFDA Info on Medication

Application NumberANDA202337, ANDA201951Brand NameDOXEPINGeneric NameDOXEPINManufacturersArchis Pharma LLC, Actavis Pharma, Inc.product_ndc72819-161, 72819-162, 0228-3315, 0228-3316Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDOXEPIN HYDROCHLORIDERXCUI966787, 966793spl_idd9a42f8a-b632-8bbb-e053-2a95a90a5408, aeefed70-09dc-4efa-809e-b80fe14656a6spl_set_ide3eac8e4-224e-4b7b-81d3-071301f914fa, c42333f8-1add-4f33-9458-6fe4436874a1Package NDC 72819-161-03, 72819-161-10, 72819-161-11, 72819-162-03, 72819-162-10, 72819-162- ... UNII3U9A0FE9N5

42)

drugcharacterization2medicinalproductFIORICETdrugrecurreadministration3

activesubstance

activesubstancenameACETAMINOPHEN\BUTALBITAL\CAFFEINE

openFDA Info on Medication

Application NumberANDA040885Brand NameFIORICETGeneric NameBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEManufacturersActavis Pharma, Inc.product_ndc52544-080Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsACETAMINOPHEN, BUTALBITAL, CAFFEINERXCUI889520, 1432261spl_id14ca4151-a727-4708-8e35-8eb08e175db8spl_set_idc018be7d-f7b8-45e2-97b8-8e7a71740657Package NDC52544-080-01NUIN0000175693, M0002177, N0000175739, N0000175729, N0000175790, M0023046Established Pharmacologic ClassBarbiturate [EPC], Central Nervous System Stimulant [EPC], Methylxanthine [EPC]Chemical StructureBarbiturates [CS], Xanthines [CS]Physiologic/Pharmacodynamic EffectCentral Nervous System Stimulation [PE]UNII362O9ITL9D, KHS0AZ4JVK, 3G6A5W338E

43)

drugcharacterization2medicinalproductFOCALINdrugrecurreadministration3

activesubstance

activesubstancenameDEXMETHYLPHENIDATE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021278, NDA021802Brand NameFOCALIN, FOCALIN XRGeneric NameDEXMETHYLPHENIDATE HYDROCHLORIDEManufacturersNovartis Pharmaceuticals Corporationproduct_ndc 0078-0380, 0078-0381, 0078-0382, 0078-0430, 0078-0433, 0078-0608, 0078-0609, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDEXMETHYLPHENIDATE HYDROCHLORIDERXCUI 899518, 899519, 899548, 899549, 899557, 899559, 899439, 899441, 899461, 899463, ... spl_idd2e2d2a1-ab3e-4803-a421-c453b37f4da7, 7b03dfec-6250-40b8-96b6-67e47a9377a1spl_set_id7c552f11-e24a-4d9b-bb8d-be10c928eca8, 1a1da905-42a0-4748-9c39-67eca45decccPackage NDC 0078-0380-05, 0078-0381-05, 0078-0382-05, 0078-0433-05, 0078-0608-05, 0078-0609- ... UNII1678OK0E08

44)

drugcharacterization2medicinalproductHYDROXYZINEdrugrecurreadministration3

activesubstance

activesubstancenameHYDROXYZINE\HYDROXYZINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA040808Brand NameHYDROXYZINE HYDROCHLORIDEGeneric NameHYDROXYZINEManufacturersAmneal Pharmaceuticals LLCproduct_ndc65162-575, 65162-671, 65162-577Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsHYDROXYZINE HYDROCHLORIDERXCUI995218, 995258, 995281spl_id8dad3af3-9788-466a-992a-6e261a3a7600spl_set_id89901966-724b-4773-98b8-ea663ceabd53Package NDC 65162-575-10, 65162-575-11, 65162-575-50, 65162-671-10, 65162-671-11, 65162-671- ... UNII76755771U3

45)

drugcharacterization2medicinalproductKEPPRAdrugrecurreadministration3

activesubstance

activesubstancenameLEVETIRACETAM

openFDA Info on Medication

Application NumberNDA021872, NDA021505, NDA021035, NDA022285Brand NameKEPPRA, KEPPRA XRGeneric NameLEVETIRACETAMManufacturersUCB, Inc.product_ndc 50474-002, 50474-001, 50474-594, 50474-595, 50474-596, 50474-597, 50474-598, 504 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsLEVETIRACETAMRXCUI 647121, 647123, 261335, 261336, 284391, 311288, 311289, 311290, 387003, 403884, ... spl_id 4a48c061-40c9-41d9-be30-e9521c3e03b5, f5f32bff-c998-43b5-920c-02f3fea3b46b, d6d8 ... spl_set_id c6d5784d-abf9-45fe-ac5a-d5c53bd50f7e, 3ca9df05-a506-4ec8-a4fe-320f1219ab21, 2919 ... Package NDC 50474-002-63, 50474-594-40, 50474-595-40, 50474-596-40, 50474-597-66, 50474-001- ... NUIN0000008486Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII44YRR34555

46)

drugcharacterization2medicinalproductNEURONTINdrugrecurreadministration3

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

47)

drugcharacterization2medicinalproductPERCOCETdrugrecurreadministration3

activesubstance

activesubstancenameACETAMINOPHEN\OXYCODONE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA040330Brand NamePERCOCETGeneric NameOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENManufacturersEndo Pharmaceuticals Inc.product_ndc63481-623, 63481-627, 63481-628, 63481-629Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsACETAMINOPHEN, OXYCODONE HYDROCHLORIDERXCUI1049214, 1049221, 1049225, 1049625, 1049635, 1049637, 1049640, 1049642spl_id8a04ce2f-d576-469f-91bc-5ed75e27e47espl_set_id4dd36cf5-8f73-404a-8b1d-3bd53bd90c25Package NDC63481-627-70, 63481-623-70, 63481-623-85, 63481-628-70, 63481-629-70UNIIC1ENJ2TE6C, 362O9ITL9D

48)

drugcharacterization2medicinalproductROZEREMdrugrecurreadministration3

activesubstance

activesubstancenameRAMELTEON

openFDA Info on Medication

Application NumberNDA021782Brand NameROZEREMGeneric NameRAMELTEONManufacturersTakeda Pharmaceuticals America, Inc.product_ndc64764-805Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRAMELTEONRXCUI577348, 603162spl_idab007fde-2fd9-4b4c-9b1a-39b9e3e2fe0bspl_set_id9de82310-70e8-47b9-b1fc-6c6848b99455Package NDC64764-805-30, 64764-805-10, 64764-805-22NUIN0000175743, N0000000250Established Pharmacologic ClassMelatonin Receptor Agonist [EPC]Mechanism of ActionMelatonin Receptor Agonists [MoA]UNII901AS54I69

49)

drugcharacterization2medicinalproductTOPAMAXdrugrecurreadministration3

activesubstance

activesubstancenameTOPIRAMATE

openFDA Info on Medication

Application NumberNDA020505, NDA020844Brand NameTOPAMAXGeneric NameTOPIRAMATEManufacturersJanssen Pharmaceuticals, Inc.product_ndc50458-639, 50458-640, 50458-641, 50458-642, 50458-647, 50458-645Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTOPIRAMATERXCUI 151226, 151227, 151228, 151229, 152855, 199888, 199889, 199890, 205315, 205316, ... spl_id095baa56-cc0a-4711-b8e4-49b1401b699espl_set_id21628112-0c47-11df-95b3-498d55d89593Package NDC 50458-639-65, 50458-640-65, 50458-641-65, 50458-642-65, 50458-647-65, 50458-645- ... NUIN0000008486, N0000185506, N0000182140Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]Mechanism of ActionCytochrome P450 3A4 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA]UNII0H73WJJ391

50)

drugcharacterization2medicinalproductMAXAIRdrugrecurreadministration3

activesubstance

activesubstancenamePIRBUTEROL ACETATE

51)

drugcharacterization2medicinalproductDHE 45drugrecurreadministration3

52)

drugcharacterization2medicinalproductMARINOLdrugrecurreadministration3

activesubstance

activesubstancenameDRONABINOL

openFDA Info on Medication

Application NumberNDA018651Brand NameMARINOLGeneric NameDRONABINOLManufacturersThePharmaNetwork, LLCproduct_ndc53097-568, 53097-569, 53097-570, 53097-571, 53097-572, 53097-573Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDRONABINOLRXCUI197634, 197635, 197636, 205641, 205642, 205645spl_id628f9609-6583-49be-be77-b64cfbc46fd7, d0efeeec-640d-43c3-8f0a-d31324a11c68spl_set_id628f9609-6583-49be-be77-b64cfbc46fd7, d0efeeec-640d-43c3-8f0a-d31324a11c68Package NDC 53097-568-60, 53097-569-60, 53097-570-60, 53097-571-60, 53097-572-60, 53097-573- ... NUIN0000175782, M0003267Established Pharmacologic ClassCannabinoid [EPC]Chemical StructureCannabinoids [CS]UNII7J8897W37S

53)

drugcharacterization2medicinalproductIRONdrugrecurreadministration3

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

54)

drugcharacterization2medicinalproductXANAXdrugrecurreadministration3

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

55)

drugcharacterization2medicinalproductZOFRANdrugrecurreadministration3

activesubstance

activesubstancenameONDANSETRON HYDROCHLORIDE

56)

drugcharacterization2medicinalproductACETAZOLAMIDE.drugrecurreadministration3

activesubstance

activesubstancenameACETAZOLAMIDE

openFDA Info on Medication

Application Number ANDA200880, ANDA209734, ANDA040195, ANDA207503, ANDA203434, ANDA090779, ANDA0409 ... Brand NameACETAZOLAMIDEGeneric NameACETAZOLAMIDE SODIUM, ACETAZOLAMIDEManufacturers Mylan Institutional LLC, Strides Pharma Science Limited, Taro Pharmaceuticals U. ... product_ndc 67457-853, 64380-833, 64380-834, 51672-4022, 51672-4023, 51991-884, 51991-885, 5 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUS, ORALActive IngredientsACETAZOLAMIDE SODIUM, ACETAZOLAMIDERXCUI307702, 197303, 197304, 562524spl_id 521838b0-a10d-495f-a014-f9ff25a6b6f3, e0a3495b-7944-4433-bba6-057a4ea81f7e, e379 ... spl_set_id 521838b0-a10d-495f-a014-f9ff25a6b6f3, 4813b9dd-5f58-44bb-ad64-cdb331828080, abeb ... Package NDC 67457-853-50, 64380-833-06, 64380-833-46, 64380-834-06, 64380-834-46, 51672-4022 ... UNII429ZT169UH, O3FX965V0INUIN0000175517, N0000000235, M0020790Established Pharmacologic ClassCarbonic Anhydrase Inhibitor [EPC]Mechanism of ActionCarbonic Anhydrase Inhibitors [MoA]Chemical StructureSulfonamides [CS]

57)

drugcharacterization2medicinalproductAMITRIPTYLINE HCLdrugrecurreadministration3

activesubstance

activesubstancenameAMITRIPTYLINE

openFDA Info on Medication

58)

drugcharacterization2medicinalproductFLAXSEEDdrugrecurreadministration3

activesubstance

activesubstancenameFLAX SEED

59)

drugcharacterization2medicinalproductRELPAXdrugrecurreadministration3

activesubstance

activesubstancenameELETRIPTAN HYDROBROMIDE

openFDA Info on Medication

Application NumberNDA021016Brand NameRELPAXGeneric NameELETRIPTAN HYDROBROMIDEManufacturersRoerigproduct_ndc0049-2330, 0049-2340Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsELETRIPTAN HYDROBROMIDERXCUI359493, 359494, 404443, 404444spl_id60fa2e8b-4d0d-4546-a087-3f0efb3e7560spl_set_id85745375-fcb6-4edc-b6db-a77b4a5f3e8cPackage NDC0049-2330-79, 0049-2330-45, 0049-2340-79, 0049-2340-45, 0049-2340-05UNIIM41W832TA3

60)

drugcharacterization2medicinalproductREMERONdrugrecurreadministration3

activesubstance

activesubstancenameMIRTAZAPINE

openFDA Info on Medication

Application NumberNDA020415Brand NameREMERONGeneric NameMIRTAZAPINEManufacturersOrganon LLCproduct_ndc78206-160, 78206-161, 78206-156, 78206-158, 78206-159Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMIRTAZAPINEspl_id3dc49c6b-23a6-41ed-909e-98b5c179130fspl_set_id98ad1917-a094-44f5-a28f-a64a8cfcd887Package NDC 78206-160-01, 78206-161-01, 78206-156-99, 78206-156-01, 78206-158-99, 78206-158- ... UNIIA051Q2099Q

61)

drugcharacterization2medicinalproductVANOSdrugrecurreadministration3

activesubstance

activesubstancenameFLUOCINONIDE

openFDA Info on Medication

Application NumberNDA021758Brand NameVANOSGeneric NameFLUOCINONIDEManufacturersBausch Health US, LLCproduct_ndc99207-525Product TypeHUMAN PRESCRIPTION DRUGRouteTOPICALActive IngredientsFLUOCINONIDERXCUI485647, 543484spl_ida075b415-7d7c-405a-9645-bdd4c4f92990spl_set_id95cb19a0-4b71-4c66-92bd-901cfd223301Package NDC99207-525-02, 99207-525-30, 99207-525-60, 99207-525-10NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNII2W4A77YPAN

62)

drugcharacterization2medicinalproductDILAUDIDdrugrecurreadministration3

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

63)

drugcharacterization2medicinalproductNAPROXEN.drugrecurreadministration3

activesubstance

activesubstancenameNAPROXEN

openFDA Info on Medication

Application Number ANDA091416, ANDA215776, NDA018965, ANDA204872, ANDA091432, ANDA074140, ANDA07592 ... Brand NameNAPROXEN, NAPROSYN, BACK AND MUSCLE PAIN, EC-NAPROSYNGeneric NameNAPROXEN, NAPROXEN SODIUMManufacturers MARKSANS PHARMA LIMITED, Camber Pharmaceuticals, Inc., Allegis Holdings, LLC, Am ... product_ndc 25000-138, 25000-139, 25000-140, 31722-682, 71297-200, 46122-564, 69543-425, 695 ... Product TypeHUMAN PRESCRIPTION DRUG, HUMAN OTC DRUGRouteORALActive IngredientsNAPROXEN, NAPROXEN SODIUMRXCUI 198012, 198013, 198014, 311913, 849574, 311915, 603103, 207093, 849398, 849431, ... spl_id 09a45eee-ddf8-428a-bbe9-39e691792356, e179766f-2524-7087-e053-2995a90a5fe6, b61f ... spl_set_id 1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c8, fd5e8d84-f92c-4f4b-ab0d-4cda7cf826bd, bc97 ... Package NDC 25000-138-03, 25000-138-14, 25000-138-21, 25000-138-31, 25000-138-98, 25000-139- ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNII57Y76R9ATQ, 9TN87S3A3C

64)

drugcharacterization2medicinalproductSONATAdrugrecurreadministration3

activesubstance

activesubstancenameZALEPLON

65)

drugcharacterization2medicinalproductNASACORTdrugrecurreadministration3

activesubstance

activesubstancenameTRIAMCINOLONE ACETONIDE

66)

drugcharacterization2medicinalproductIMITREXdrugrecurreadministration3

activesubstance

activesubstancenameSUMATRIPTAN SUCCINATE

openFDA Info on Medication

Application NumberNDA020080, NDA020132, NDA020626Brand NameIMITREXGeneric NameSUMATRIPTANManufacturersGlaxoSmithKline LLCproduct_ndc 0173-0478, 0173-0739, 0173-0479, 0173-0735, 0173-0736, 0173-0737, 0173-0523, 017 ... Product TypeHUMAN PRESCRIPTION DRUGRouteSUBCUTANEOUS, ORAL, NASALActive IngredientsSUMATRIPTAN SUCCINATE, SUMATRIPTANRXCUI 758523, 860088, 1657160, 1657173, 208450, 209169, 284460, 313160, 313161, 315223 ... spl_id ae0a5f62-ace2-491d-bcb4-49c28bf1e0f1, db469bf0-d651-450f-87cb-9fcaa88459be, 7aca ... spl_set_id fee7d073-0b99-48f2-7985-0d8cf970894b, 584abe73-8290-4484-ff8e-5890831c095e, cc11 ... Package NDC 0173-0739-00, 0173-0739-02, 0173-0479-00, 0173-0478-00, 0173-0735-00, 0173-0736- ... UNIIJ8BDZ68989, 8R78F6L9VONUIN0000175763, N0000175764, N0000175765Mechanism of ActionSerotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA]Established Pharmacologic ClassSerotonin-1b and Serotonin-1d Receptor Agonist [EPC]

67)

drugcharacterization2medicinalproductLEXAPROdrugrecurreadministration3

activesubstance

activesubstancenameESCITALOPRAM OXALATE

openFDA Info on Medication

Application NumberNDA021323Brand NameLEXAPROGeneric NameESCITALOPRAMManufacturersAllergan, Inc.product_ndc0456-2005, 0456-2010, 0456-2020, 0456-2101Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESCITALOPRAM OXALATERXCUI349332, 351249, 351250, 351285, 352272, 352273, 404408, 404420spl_idd6a08762-d20a-47c9-b92e-b5dde195489cspl_set_id13bb8267-1cab-43e5-acae-55a4d957630aPackage NDC 0456-2005-01, 0456-2010-01, 0456-2010-11, 0456-2010-63, 0456-2020-01, 0456-2020- ... UNII5U85DBW7LO

68)

drugcharacterization2medicinalproductLUNESTAdrugrecurreadministration3

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

69)

drugcharacterization2medicinalproductNAMENDAdrugrecurreadministration3

activesubstance

activesubstancenameMEMANTINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA022525, NDA021487Brand NameNAMENDA XR, NAMENDAGeneric NameMEMANTINE HYDROCHLORIDEManufacturersAllergan, Inc.product_ndc 0456-3407, 0456-3414, 0456-3421, 0456-3428, 0456-3400, 0456-3210, 0456-3205, 045 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMEMANTINE HYDROCHLORIDERXCUI 996594, 996597, 996603, 996605, 996609, 996611, 996615, 996617, 996624, 996633, ... spl_id3fae1fd7-ac36-4564-9de9-84533cea4636, 4f68a65c-d6e1-43b8-87ea-42f680f09db5spl_set_id710f523f-0158-4639-8ce7-57598247d48c, b9f27baf-aa2a-443a-9ef5-e002d23407baPackage NDC 0456-3407-33, 0456-3414-11, 0456-3414-63, 0456-3414-33, 0456-3414-90, 0456-3421- ... UNIIJY0WD0UA60

70)

drugcharacterization2medicinalproductTEMAZEPAM.drugrecurreadministration3

activesubstance

activesubstancenameTEMAZEPAM

openFDA Info on Medication

Application Number ANDA203482, ANDA071620, ANDA211542, ANDA071456, ANDA071457, ANDA201781, ANDA0785 ... Brand NameTEMAZEPAM, RESTORILGeneric NameTEMAZEPAMManufacturers Amneal Pharmaceuticals LLC, Actavis Pharma, Inc., Alembic Pharmaceuticals Limite ... product_ndc 65162-556, 65162-583, 65162-584, 65162-557, 0228-2076, 0228-2077, 46708-379, 467 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTEMAZEPAMRXCUI198241, 198242, 198243, 485489, 208463, 208464, 208465, 539384spl_id 59b42c1d-f7af-495b-a68e-aba450acc091, 588073ce-4e6f-40fb-bd1f-26fd40c7589f, 2676 ... spl_set_id be68c6e0-17ad-40fe-9bc1-58abe24b53f6, a4370eb4-b00d-4247-af8d-980e59fbbec6, db83 ... Package NDC 65162-583-03, 65162-583-10, 65162-583-50, 65162-583-11, 65162-556-03, 65162-556- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIICHB1QD2QSS

71)

drugcharacterization2medicinalproductTYLENOL WITH CODEINEdrugrecurreadministration3

activesubstance

activesubstancenameACETAMINOPHEN\CODEINE PHOSPHATE

openFDA Info on Medication

72)

drugcharacterization2medicinalproductCATAPRESdrugrecurreadministration3

activesubstance

activesubstancenameCLONIDINE HYDROCHLORIDE

73)

drugcharacterization2medicinalproductKYTRILdrugrecurreadministration3

activesubstance

activesubstancenameGRANISETRON HYDROCHLORIDE

74)

drugcharacterization2medicinalproductMETANXdrugrecurreadministration3

activesubstance

activesubstancenameLEVOMEFOLATE CALCIUM\METHYLCOBALAMIN\PYRIDOXAL PHOSPHATE ANHYDROUS

75)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugstructuredosagenumb4.5drugstructuredosageunit002drugdosagetext4.5 G, BIDdrugdosageformORAL SOLUTIONdrugadministrationroute048drugstartdateformat602drugstartdate//2012drugenddateformat602drugenddate//2014actiondrug5drugadditional3

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

76)

drugcharacterization2medicinalproductADVILdrugrecurreadministration3

activesubstance

activesubstancenameIBUPROFEN

openFDA Info on Medication

Application NumberNDA201803, NDA018989, NDA020402Brand NameADVILGeneric NameIBUPROFEN SODIUM, IBUPROFEN, IBUPROFEN TABLET COATEDManufacturersGlaxoSmithKline Consumer Healthcare Holdings (US) LLC, Mechanical Servants LLCproduct_ndc 0573-0133, 0573-0134, 0573-0150, 0573-0165, 0573-0154, 0573-0151, 0573-0161, 057 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsIBUPROFEN SODIUM, IBUPROFENRXCUI153008, 310965, 310964, 731533spl_id aeda1ef6-01ea-48ce-81dd-15cef15b3c0d, eb3fc8e0-b90f-4141-a5fa-3d11db900f64, c997 ... spl_set_id 5be198b8-396e-4b44-8819-e2e3b5d2ad0e, 1a665e64-9f30-be37-4a83-38789f1f1e89, 1f01 ... Package NDC 0573-0133-20, 0573-0133-40, 0573-0133-80, 0573-0133-02, 0573-0133-04, 0573-0133- ... UNIIRM1CE97Z4N, WK2XYI10QMNUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]

77)

drugcharacterization2medicinalproductCYMBALTAdrugrecurreadministration3

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

78)

drugcharacterization2medicinalproductHYLATOPICPLUSdrugrecurreadministration3

79)

drugcharacterization2medicinalproductLITHIUM CARBONATE.drugrecurreadministration3

activesubstance

activesubstancenameLITHIUM CARBONATE

openFDA Info on Medication

Brand Name LITHIUM CARBONICUM, LITHIUM CARBONATE, LITHIUM CARBONATE ER, RHEUMATSM, LITHIUM ... Generic NameLITHIUM CARBONATE, LITHIUM CARBONATE EXTENDED-RELEASE TABLETManufacturers Boiron, Mylan Pharmaceuticals Inc., Heritage Pharmaceuticals Inc. d/b/a Avet Pha ... product_ndc 0220-3128, 0378-1300, 23155-763, 0054-2526, 0054-8528, 0054-4527, 0054-8526, 005 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLITHIUM CARBONATEspl_id 861df6e6-46cc-632d-e053-2a91aa0ae9a3, 4dea5284-2539-43e3-8002-fed27008f189, 84eb ... spl_set_id 861df6e6-46cb-632d-e053-2a91aa0ae9a3, 785a0327-998b-4154-9461-b72cb78e2739, 074e ... Package NDC 0220-3128-41, 0378-1300-01, 0378-1300-05, 23155-763-05, 23155-763-01, 0054-8528- ... UNII2BMD2GNA4V, 5Z6E9K79YVApplication Number ANDA202288, ANDA205532, NDA017812, NDA018558, ANDA204445, ANDA090702, ANDA202219 ... RXCUI197891, 197889, 197890, 197893, 311355, 756059, 197892, 206786

80)

drugcharacterization2medicinalproductMAXALTdrugrecurreadministration3

activesubstance

activesubstancenameRIZATRIPTAN BENZOATE

openFDA Info on Medication

Application NumberNDA020864Brand NameMAXALTGeneric NameRIZATRIPTAN BENZOATEManufacturersOrganon LLCproduct_ndc78206-142, 78206-143Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsRIZATRIPTAN BENZOATEspl_idde376dab-ae25-4825-9c3b-fd0e3688e41espl_set_id007b4644-e0e7-4863-9ae3-fe09676b3f5fPackage NDC78206-142-99, 78206-142-01, 78206-143-99, 78206-143-01UNIIWR978S7QHH

81)

drugcharacterization2medicinalproductNASONEXdrugrecurreadministration3

activesubstance

activesubstancenameMOMETASONE FUROATE

82)

drugcharacterization2medicinalproductPROPRANOLOLdrugrecurreadministration3

activesubstance

activesubstancenamePROPRANOLOL\PROPRANOLOL HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA075826Brand NamePROPRANOLOLGeneric NamePROPRANOLOL HYDROCHLORIDEManufacturersFresenius Kabi USA, LLCproduct_ndc63323-604Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAVENOUSActive IngredientsPROPRANOLOL HYDROCHLORIDERXCUI856443spl_iddb24d808-268b-4bec-bd48-7b66d2bb5951spl_set_idf14ea537-dd5c-4c78-9037-9a85e9e610efPackage NDC63323-604-01UNIIF8A3652H1V

83)

drugcharacterization2medicinalproductRITALINdrugrecurreadministration3

activesubstance

activesubstancenameMETHYLPHENIDATE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA010187, NDA021284Brand NameRITALIN, RITALIN LAGeneric NameMETHYLPHENIDATE HYDROCHLORIDEManufacturersNovartis Pharmaceuticals Corporationproduct_ndc0078-0439, 0078-0440, 0078-0441, 0078-0370, 0078-0371, 0078-0372, 0078-0424Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETHYLPHENIDATE HYDROCHLORIDERXCUI 1091150, 1091379, 1091392, 1091395, 1091497, 1091500, 1091143, 1091167, 1091182, ... spl_id24697cdc-7470-4b76-a755-5c223048c1ce, 8c4180f5-acfa-486f-a7ed-f5712f0682f7spl_set_idc0bf0835-6a2f-4067-a158-8b86c4b0668a, effd952d-ac94-47bb-b107-589a4934dccaPackage NDC 0078-0439-05, 0078-0440-05, 0078-0441-05, 0078-0370-05, 0078-0371-05, 0078-0372- ... UNII4B3SC438HI

84)

drugcharacterization2medicinalproductSTRATTERAdrugrecurreadministration3

activesubstance

activesubstancenameATOMOXETINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021411Brand NameSTRATTERAGeneric NameATOMOXETINE HYDROCHLORIDEManufacturersEli Lilly and Companyproduct_ndc0002-3227, 0002-3238, 0002-3228, 0002-3229, 0002-3239, 0002-3250, 0002-3251Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsATOMOXETINE HYDROCHLORIDERXCUI 349591, 349592, 349593, 349594, 349595, 352317, 352318, 352319, 352320, 352321, ... spl_id6963b20c-fce1-414e-90b6-5d0730f93191spl_set_id309de576-c318-404a-bc15-660c2b1876fbPackage NDC 0002-3227-30, 0002-3238-30, 0002-3228-30, 0002-3229-30, 0002-3239-30, 0002-3250- ... UNII57WVB6I2W0

85)

drugcharacterization2medicinalproductFROVAdrugrecurreadministration3

activesubstance

activesubstancenameFROVATRIPTAN SUCCINATE

openFDA Info on Medication

Application NumberNDA021006Brand NameFROVAGeneric NameFROVATRIPTAN SUCCINATEManufacturersEndo Pharmaceuticals, Inc.product_ndc63481-025Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFROVATRIPTAN SUCCINATERXCUI349462, 352058spl_id492b9727-53ae-47e2-a832-08bb7930b5bbspl_set_idc0703630-9ce8-4259-841e-71fd2019fa66Package NDC63481-025-09, 63481-025-12UNIID28J6W18HY

86)

drugcharacterization2medicinalproductATIVANdrugrecurreadministration3

activesubstance

activesubstancenameLORAZEPAM

openFDA Info on Medication

Application NumberNDA017794, NDA018140Brand NameATIVANGeneric NameLORAZEPAMManufacturersBausch Health US LLC, Hikma Pharmaceuticals USA Inc.product_ndc0187-0063, 0187-0064, 0187-0065, 0641-6000, 0641-6001, 0641-6003, 0641-6002Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsLORAZEPAMRXCUI 104719, 197900, 197901, 197902, 206821, 206828, 206819, 206820, 238100, 238101, ... spl_id0c599118-4213-4a51-bd2d-a162ac18a940, 2d4cea58-1dfe-4bc0-bd5a-415ced5420dbspl_set_id89057c93-8155-4040-acec-64e877bd2b4c, 5fc0e987-61c9-40c4-b0d5-fcea07c8733ePackage NDC 0187-0063-01, 0187-0063-50, 0187-0063-10, 0187-0064-01, 0187-0064-50, 0187-0064- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIO26FZP769L

87)

drugcharacterization2medicinalproductMULTIVITAMINSdrugrecurreadministration3

activesubstance

activesubstancenameVITAMINS

88)

drugcharacterization2medicinalproductSPRIXdrugrecurreadministration3

activesubstance

activesubstancenameKETOROLAC TROMETHAMINE

openFDA Info on Medication

Application NumberNDA022382Brand NameSPRIXGeneric NameKETOROLAC TROMETHAMINEManufacturersZyla Life Sciences US Inc.product_ndc69344-144Product TypeHUMAN PRESCRIPTION DRUGRouteNASALActive IngredientsKETOROLAC TROMETHAMINERXCUI1797855, 1797857spl_idba6f68e8-84b8-48d7-8527-4bcfdb80c8d8spl_set_id97005a1c-167e-4676-bae7-e49b38c36f9ePackage NDC69344-144-63, 69344-144-53, 69344-144-43UNII4EVE5946BQ

89)

drugcharacterization2medicinalproductADDERALL XRdrugrecurreadministration3

activesubstance

activesubstancename AMPHETAMINE ASPARTATE\AMPHETAMINE SULFATE\DEXTROAMPHETAMINE SACCHARATE\DEXTROAMP ...

openFDA Info on Medication

Application NumberNDA021303Brand NameADDERALL XRGeneric Name DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND ... ManufacturersTakeda Pharmaceuticals America, Inc.product_ndc54092-381, 54092-383, 54092-385, 54092-387, 54092-389, 54092-391Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive Ingredients AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHA ... RXCUI 861221, 861222, 861223, 861224, 861225, 861226, 861227, 861228, 861232, 861233, ... spl_ide3546445-6a4a-46a2-af40-026167005259spl_set_idaff45863-ffe1-4d4f-8acf-c7081512a6c0Package NDC 54092-381-01, 54092-383-01, 54092-385-01, 54092-387-01, 54092-389-01, 54092-391- ... UNIIJJ768O327N, O1ZPV620O4, G83415V073, 6DPV8NK46S

summary

narrativeincludeclinicalCASE EVENT DATE: 2016