Adverse Event Report

Report

Version of Safety Report ID10Safety Report ID11973096primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate14/10/2021reporttype2serious1seriousnessother1receivedateformat102Date Received28/01/2016receiptdateformat102Date Last Updated05/07/2021fulfillexpeditecriteria1companynumbUS-JAZZ-JPI-P-029912duplicate1

Report Duplicate

duplicatesourceJAZZduplicatenumbUS-JAZZ-JPI-P-029912

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age44Unit of Onset AgeyearsWeight68.18SexFemale

Reaction

1)

reactionmeddraversionpt24.0ReactionBlood pressure increasedOutcomeRecovered/resolved

2)

reactionmeddraversionpt24.0ReactionEssential tremorOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt24.0ReactionEpigastric discomfortOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt24.0ReactionMyoclonusOutcomeRecovered/resolved

5)

reactionmeddraversionpt24.0ReactionGastrointestinal surgeryOutcomeRecovered/resolved

6)

reactionmeddraversionpt24.0ReactionPalpitationsOutcomeRecovered/resolved

7)

reactionmeddraversionpt24.0ReactionDysuriaOutcomeRecovered/resolved

8)

reactionmeddraversionpt24.0ReactionDizzinessOutcomeRecovered/resolved

9)

reactionmeddraversionpt24.0ReactionVomitingOutcomeRecovered/resolved

10)

reactionmeddraversionpt24.0ReactionCondition aggravatedOutcomeNot recovered/not resolved

11)

reactionmeddraversionpt24.0ReactionBlood potassium decreasedOutcomeRecovered/resolved

12)

reactionmeddraversionpt24.0ReactionFlushingOutcomeUnknown

13)

reactionmeddraversionpt24.0ReactionAbdominal painOutcomeRecovered/resolved

14)

reactionmeddraversionpt24.0ReactionDecreased appetiteOutcomeRecovered/resolved

15)

reactionmeddraversionpt24.0ReactionCampylobacter gastroenteritisOutcomeRecovered/resolved

16)

reactionmeddraversionpt24.0ReactionNeuropathy peripheralOutcomeNot recovered/not resolved

17)

reactionmeddraversionpt24.0ReactionSleep apnoea syndromeOutcomeRecovered/resolved

18)

reactionmeddraversionpt24.0ReactionGastritisOutcomeNot recovered/not resolved

19)

reactionmeddraversionpt24.0ReactionRaynaud^s phenomenonOutcomeNot recovered/not resolved

20)

reactionmeddraversionpt24.0ReactionRestlessnessOutcomeNot recovered/not resolved

21)

reactionmeddraversionpt24.0ReactionCondition aggravatedOutcomeNot recovered/not resolved

22)

reactionmeddraversionpt24.0ReactionHyperthyroidismOutcomeUnknown

23)

reactionmeddraversionpt24.0ReactionWithdrawal syndromeOutcomeRecovered/resolved

24)

reactionmeddraversionpt24.0ReactionFibromyalgiaOutcomeRecovering/resolving

25)

reactionmeddraversionpt24.0ReactionIllnessOutcomeNot recovered/not resolved

26)

reactionmeddraversionpt24.0ReactionObesityOutcomeUnknown

27)

reactionmeddraversionpt24.0ReactionSkin burning sensationOutcomeUnknown

28)

reactionmeddraversionpt24.0ReactionHeart rate increasedOutcomeRecovered/resolved

29)

reactionmeddraversionpt24.0ReactionDrug ineffectiveOutcomeUnknown

30)

reactionmeddraversionpt24.0ReactionConfusional stateOutcomeRecovered/resolved

31)

reactionmeddraversionpt24.0ReactionHeadacheOutcomeRecovered/resolved

32)

reactionmeddraversionpt24.0ReactionCognitive disorderOutcomeUnknown

33)

reactionmeddraversionpt24.0ReactionHallucinations, mixedOutcomeRecovered/resolved

34)

reactionmeddraversionpt24.0ReactionAgitationOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugstructuredosagenumb4.5drugstructuredosageunit002drugdosagetext4.5 GRAM, BIDdrugdosageformORAL SOLUTIONdrugadministrationroute048drugstartdateformat602drugstartdate//2015actiondrug1drugadditional1

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)

drugcharacterization1medicinalproductTRAZODONEdrugindicationSLEEP DISORDERactiondrug6

activesubstance

activesubstancenameTRAZODONE HYDROCHLORIDE

openFDA Info on Medication

3)

drugcharacterization1medicinalproductGRALISEdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug1drugadditional1

activesubstance

activesubstancenameGABAPENTIN

openFDA Info on Medication

Application NumberNDA022544Brand NameGRALISEGeneric NameGABAPENTINManufacturersAlmatica Pharma LLC, Assertio Therapeutics, Inc.product_ndc52427-803, 52427-806, 52427-815, 13913-004, 13913-005, 13913-006Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsGABAPENTINspl_idf0b82966-eb8f-ffed-1796-320fcd40b3c7, eda73066-488f-0e06-a1ee-25883ee7f525spl_set_id466273b1-c9fc-3930-c94b-aa11394d5140, 7d12b4e9-ed44-43c0-9e46-f6c195300f03Package NDC 52427-803-90, 52427-806-90, 52427-815-99, 13913-004-13, 13913-004-19, 13913-004- ... NUIN0000175753, N0000008486Established Pharmacologic ClassAnti-epileptic Agent [EPC]Physiologic/Pharmacodynamic EffectDecreased Central Nervous System Disorganized Electrical Activity [PE]UNII6CW7F3G59XRXCUI1115012, 1115013, 1115015, 1115016, 1806380, 1806382

4)

drugcharacterization2medicinalproductONDANSETRON HYDROCHLORIDE.drugstructuredosagenumb4drugstructuredosageunit003drugdosagetext4 MILLIGRAMdrugindicationNAUSEAdrugrecurreadministration3

activesubstance

activesubstancenameONDANSETRON HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA076183, ANDA078539, ANDA078776, ANDA090116, ANDA077729, ANDA076972, ANDA0769 ... Brand NameONDANSETRON HYDROCHLORIDE, ONDANSETRONGeneric NameONDANSETRON HYDROCHLORIDE, ONDANSETRONManufacturers Dr. Reddy's Laboratories Limited, Aurobindo Pharma Limited, NorthStar Rx LLC, La ... product_ndc 55111-153, 55111-154, 55111-156, 65862-187, 65862-188, 65862-189, 16714-671, 052 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsONDANSETRON HYDROCHLORIDERXCUI198052, 312084, 312086, 312085, 283504, 1740467, 692695, 1314133, 104894, 312087spl_id c70e1611-6d98-55f5-7b07-5af617562f48, 16e894c6-554d-4cff-b66f-a612c5cfa8a3, 6a07 ... spl_set_id 162f2088-9fb1-47e7-b88c-45104be7e7bb, 57578387-1918-4e56-a564-f14fb22340bf, ac3d ... Package NDC 55111-153-30, 55111-153-01, 55111-153-05, 55111-153-78, 55111-153-13, 55111-154- ... UNIINMH84OZK2B, 4AF302ESOSNUIN0000175817, N0000175818Mechanism of ActionSerotonin 3 Receptor Antagonists [MoA]Established Pharmacologic ClassSerotonin-3 Receptor Antagonist [EPC]

5)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugstructuredosagenumb4.5drugstructuredosageunit002drugdosagetext4.5 GRAM, BIDdrugdosageformORAL SOLUTIONdrugstartdateformat610drugstartdate/05/2014drugenddateformat602drugenddate//2015actiondrug1drugadditional1

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

6)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugdosagetextDOSE ADJUSTMENTSdrugdosageformORAL SOLUTIONdrugadministrationroute048actiondrug1drugadditional1

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

7)

drugcharacterization1medicinalproductLUNESTAdrugindicationSLEEP DISORDERactiondrug6

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

8)

drugcharacterization2medicinalproductESZOPICLONE.drugstructuredosagenumb3drugstructuredosageunit003drugdosagetext3 MILLIGRAMdrugindicationSLEEP DISORDERdrugrecurreadministration3

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application Number ANDA091124, ANDA091166, ANDA091103, ANDA091113, ANDA091024, ANDA208451, ANDA2029 ... Brand NameESZOPICLONE, LUNESTAGeneric NameESZOPICLONEManufacturers Lupin Pharmaceuticals, Inc., Glenmark Pharmaceuticals Inc. USA, Sun Pharmaceutic ... product_ndc 68180-322, 68180-323, 68180-324, 68462-382, 68462-383, 68462-384, 47335-586, 473 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, OROPHARYNGEALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id c15b2322-c078-46c1-8959-9288faaab19e, 8d6002b1-95d9-445c-8ace-e6dccea36852, 95e9 ... spl_set_id 7068c455-691e-4c56-9857-b7b4e13f4784, 584dc66c-063a-4552-a056-74b811e2bc80, 8bb1 ... Package NDC 68180-322-01, 68180-322-11, 68180-322-13, 68180-323-01, 68180-323-02, 68180-323- ... UNIIUZX80K71OE

9)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugstructuredosagenumb3drugstructuredosageunit002drugdosagetext3 GRAM, BIDdrugdosageformORAL SOLUTIONdrugadministrationroute048drugindicationNARCOLEPSYdrugstartdateformat610drugstartdate/03/2008drugenddateformat610drugenddate/04/2008actiondrug1drugadditional1

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)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugstructuredosagenumb4.5drugstructuredosageunit002drugdosagetext4.5 GRAM, BIDdrugdosageformORAL SOLUTIONdrugadministrationroute048drugstartdateformat102drugstartdate14/04/2009actiondrug1drugadditional1

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

11)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugstructuredosagenumb3drugstructuredosageunit002drugdosagetext3 GRAM, SECOND DOSEdrugdosageformORAL SOLUTIONdrugadministrationroute048drugstartdateformat610drugstartdate/02/2013drugenddateformat610drugenddate/02/2013actiondrug1drugadditional1

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

12)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugstructuredosagenumb3.25drugstructuredosageunit002drugdosagetext3.25 GRAM, BIDdrugdosageformORAL SOLUTIONdrugadministrationroute048drugstartdateformat610drugstartdate/02/2013actiondrug1drugadditional1

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

13)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugstructuredosagenumb4.5drugstructuredosageunit002drugdosagetext4.5 GRAM, FIRST DOSEdrugdosageformORAL SOLUTIONdrugadministrationroute048drugstartdateformat610drugstartdate/11/2013drugenddateformat610drugenddate/01/2014actiondrug1drugadditional1

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)

drugcharacterization1medicinalproductNORVASCdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug1drugadditional1

activesubstance

activesubstancenameAMLODIPINE BESYLATE

openFDA Info on Medication

Application NumberNDA019787Brand NameNORVASCGeneric NameAMLODIPINE BESYLATEManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc0069-1520, 0069-1530, 0069-1540Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsAMLODIPINE BESYLATERXCUI197361, 212542, 212549, 212575, 308135, 308136spl_id80f34426-dbf5-41e4-9aaa-75526d0f3cf0spl_set_idabd6a2ca-40c2-485c-bc53-db1c652505edPackage NDC 0069-1520-68, 0069-1530-68, 0069-1530-41, 0069-1530-72, 0069-1540-68, 0069-1540- ... UNII864V2Q084H

15)

drugcharacterization2medicinalproductMELOXICAM.drugstructuredosagenumb7.5drugstructuredosageunit003drugdosagetext7.5 MILLIGRAMdrugindicationPAINdrugrecurreadministration3

activesubstance

activesubstancenameMELOXICAM

openFDA Info on Medication

Application Number ANDA077921, ANDA077932, ANDA211398, ANDA077944, ANDA078008, NDA207233, ANDA07791 ... Brand NameMELOXICAM, VIVLODEX, MOBIC, ANJESOGeneric NameMELOXICAMManufacturers Zydus Pharmaceuticals (USA) Inc., Glenmark Pharmaceuticals Inc., USA, Novitium P ... product_ndc 68382-050, 68382-051, 68462-140, 68462-141, 70954-076, 70954-077, 68180-501, 681 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsMELOXICAMRXCUI 152695, 311486, 1722349, 1722357, 1722355, 1722359, 152697, 152698, 2281106, 228 ... spl_id 7886fdfc-ac20-441f-b046-cab54cd59ae0, 1bfddea3-c305-4688-978d-36c882261be7, 1d5b ... spl_set_id 6c015f72-5ce3-4f56-8237-776fc2165b0c, c51f3abe-02bc-4544-a22f-0f2035fb2271, ce9a ... Package NDC 68382-050-16, 68382-050-01, 68382-050-05, 68382-050-40, 68382-050-30, 68382-050- ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIVG2QF83CGL

16)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugdosagetextUNKNOWN DOSEdrugdosageformORAL SOLUTIONdrugadministrationroute048drugstartdateformat102drugstartdate01/02/2013drugenddateformat610drugenddate/02/2013actiondrug1drugadditional1

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

17)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugstructuredosagenumb3.75drugstructuredosageunit002drugdosagetext3.75 GRAM, FIRST DOSEdrugdosageformORAL SOLUTIONdrugadministrationroute048drugstartdateformat610drugstartdate/02/2013drugenddateformat610drugenddate/02/2013actiondrug1drugadditional1

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

18)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugdosagetextUNKNOWN DOSEdrugdosageformORAL SOLUTIONdrugadministrationroute048drugstartdateformat102drugstartdate09/07/2019actiondrug1drugadditional1

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)

drugcharacterization1medicinalproductLYRICAdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugadditional3

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

20)

drugcharacterization2medicinalproductPANTOPRAZOLE SODIUM SESQUIHYDRATEdrugstructuredosagenumb40drugstructuredosageunit003drugdosagetext40 MILLIGRAMdrugindicationGASTRIC PH DECREASEDdrugrecurreadministration3

activesubstance

activesubstancenamePANTOPRAZOLE SODIUM

21)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugdosagetextDOSE ADJUSTMENTSdrugdosageformORAL SOLUTIONdrugadministrationroute048drugindicationCATAPLEXYactiondrug1drugadditional1

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

22)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugdosagetextDOSE ADJUSTMENTSdrugdosageformORAL SOLUTIONdrugadministrationroute048actiondrug1drugadditional1

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

23)

drugcharacterization2medicinalproductLAMOTRIGINE.drugstructuredosagenumb200drugstructuredosageunit003drugdosagetext200 MILLIGRAMdrugindicationSEIZUREdrugrecurreadministration3

activesubstance

activesubstancenameLAMOTRIGINE

openFDA Info on Medication

Application Number ANDA200672, ANDA206382, ANDA213949, ANDA078956, ANDA077633, ANDA078009, ANDA0767 ... Brand NameLAMOTRIGINE, LAMICTAL, LAMICTAL ODT, LAMOTRIGINE KIT, LAMICTAL XR, SUBVENITEGeneric Name LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAM ... Manufacturers Actavis Pharma, Inc., Dr. Reddys Laboratories Inc., Yiling Pharmaceutical, Inc., ... product_ndc 0228-1410, 0228-1435, 0228-1422, 0228-1453, 0228-1638, 0228-1580, 43598-550, 435 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLAMOTRIGINERXCUI 850087, 850091, 900156, 900164, 1098608, 1146690, 103968, 198430, 252478, 252479 ... spl_id 056504f1-1818-40cb-b75a-33fd1d907b04, c7aa46de-c5c5-2e12-e053-2a95a90af492, d627 ... spl_set_id 87beaf22-593d-4170-bb58-332c615ef90d, 54ea1ec3-876b-4d3a-a92b-1a6d70951de0, f7de ... Package NDC 0228-1410-03, 0228-1435-03, 0228-1422-03, 0228-1453-03, 0228-1638-03, 0228-1580- ... 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

24)

drugcharacterization2medicinalproductARMOUR THYROIDdrugstructuredosagenumb45drugstructuredosageunit003drugdosagetext45 MILLIGRAMdrugindicationTHYROID DISORDERdrugrecurreadministration3

activesubstance

activesubstancenameTHYROID, PORCINE

openFDA Info on Medication

Brand NameARMOUR THYROIDGeneric NameTHYROID, PORCINEManufacturersAllergan, Inc.product_ndc 0456-0457, 0456-0458, 0456-0459, 0456-0460, 0456-0461, 0456-0462, 0456-0463, 045 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTHYROID, PORCINERXCUI 198278, 208534, 208535, 208540, 208543, 208544, 208545, 208547, 208549, 208551, ... spl_idf51844cf-33ae-4b36-ba2c-21c53e45847dspl_set_id56b41079-60db-4256-9695-202b3a65d13dPackage NDC 0456-0457-01, 0456-0458-01, 0456-0458-11, 0456-0458-63, 0456-0459-01, 0456-0459- ... UNII6RV024OAUQ

25)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugstructuredosagenumb3.5drugstructuredosageunit002drugdosagetext3.5 GRAM, SECOND DOSEdrugdosageformORAL SOLUTIONdrugadministrationroute048drugstartdateformat610drugstartdate/11/2013drugenddateformat610drugenddate/01/2014actiondrug1drugadditional1

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)

drugcharacterization1medicinalproductCIPROFLOXACIN.drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugadditional3

activesubstance

activesubstancenameCIPROFLOXACIN

openFDA Info on Medication

Application Number NDA207986, ANDA076555, ANDA076912, ANDA078024, NDA021918, ANDA075593, ANDA076794 ... Brand NameOTIPRIO, CIPROFLOXACIN, CIPROFLOXACIN OTIC, CETRAXAL, CIPROGeneric NameCIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN TABLETSManufacturers Otonomy, Inc., Akorn, Taro Pharmaceuticals U.S.A., Inc., Baxter Healthcare Corpo ... product_ndc 69251-201, 17478-714, 51672-4085, 51672-4086, 51672-4087, 36000-008, 36000-009, ... Product TypeHUMAN PRESCRIPTION DRUGRouteAURICULAR (OTIC), INTRATYMPANIC, OPHTHALMIC, ORAL, INTRAVENOUSActive IngredientsCIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDEspl_id cea66fc0-da5a-403b-886e-b0eaacce39c0, 11a698f3-9ecb-4dfc-9ef1-4b4338d884cf, 7c68 ... spl_set_id 8365e37a-0b35-497c-aab4-f25053378154, 3e9a6174-962b-400e-8ca7-4a6c32c60a5d, 6c6b ... Package NDC 69251-201-01, 17478-714-25, 17478-714-10, 17478-714-11, 51672-4085-1, 51672-4085 ... NUIN0000175937, M0023650Established Pharmacologic ClassQuinolone Antimicrobial [EPC]Chemical StructureQuinolones [CS]UNII5E8K9I0O4U, 4BA73M5E37RXCUI 309307, 197511, 197512, 309309, 1665210, 1665212, 1665227, 1665229, 848956, 1993 ...

27)

drugcharacterization2medicinalproductDICYCLOVERINEdrugstructuredosagenumb10drugstructuredosageunit003drugdosagetext10 MILLIGRAMdrugindicationGASTROINTESTINAL DISORDERdrugrecurreadministration3

activesubstance

activesubstancenameDICYCLOMINE HYDROCHLORIDE

28)

drugcharacterization2medicinalproductMODAFINIL.drugstructuredosagenumb50drugstructuredosageunit003drugdosagetext50 MG, QDdrugadministrationroute048drugindicationNARCOLEPSYdrugstartdateformat602drugstartdate//2014drugrecurreadministration3

activesubstance

activesubstancenameMODAFINIL

openFDA Info on Medication

Application Number ANDA202700, ANDA077667, ANDA202566, NDA020717, ANDA209966, ANDA078963, ANDA20719 ... Brand NameMODAFINIL, PROVIGILGeneric NameMODAFINILManufacturers Alembic Pharmaceuticals Limited, Apotex Corp., Alembic Pharmaceuticals Inc., Ris ... product_ndc 46708-385, 46708-386, 60505-2526, 60505-2527, 62332-385, 62332-386, 57237-154, 5 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMODAFINILRXCUI205324, 260218, 213471, 226426spl_id b7315903-20d7-4dce-80ea-3d33fa5f9f16, a2501635-6969-cca6-92c1-e6259d7d7708, 7aa2 ... spl_set_id 5b8496fe-b647-4ce6-aeef-71245712e46f, 944daf47-49a6-93ca-e348-4a0f1b6d937e, 41f9 ... Package NDC 46708-385-30, 46708-385-91, 46708-385-10, 46708-385-60, 46708-385-90, 46708-386- ... NUIN0000175729, N0000175651, N0000175769Physiologic/Pharmacodynamic EffectCentral Nervous System Stimulation [PE], Increased Sympathetic Activity [PE]Established Pharmacologic ClassSympathomimetic-like Agent [EPC]UNIIR3UK8X3U3D

summary

narrativeincludeclinicalCASE EVENT DATE: 2011