Adverse Event Report

Report

Version of Safety Report ID2Safety Report ID11657049primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate04/03/2016reporttype1serious1seriousnessother1receivedateformat102Date Received23/10/2015receiptdateformat102Date Last Updated01/12/2015fulfillexpeditecriteria1companynumbUS-JAZZ-2015-US-016885duplicate1

Report Duplicate

duplicatesourceJAZZduplicatenumbUS-JAZZ-2015-US-016885

Primary Source

reportercountryUS

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

SexFemale

Reaction

1)

reactionmeddraversionpt18.1ReactionSleep apnoea syndromeOutcomeRecovering/resolving

2)

reactionmeddraversionpt18.1ReactionPre-existing condition improvedOutcomeUnknown

3)

reactionmeddraversionpt18.1ReactionNeck painOutcomeNot recovered/not resolved

4)

reactionmeddraversionpt18.1ReactionPelvic painOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt18.1ReactionTherapeutic response unexpectedOutcomeUnknown

6)

reactionmeddraversionpt18.1ReactionBack painOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugdosagetextDOSE ADJUSTMENTSdrugdosageformORAL SOLUTIONdrugadministrationroute048drugstartdateformat602drugstartdate//2012drugenddateformat602drugenddate//2014actiondrug5

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)

drugcharacterization2medicinalproductFLUOXETINE HCLdrugdosagetextUNKdrugdosageformCAPSULEdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate13/10/2015

activesubstance

activesubstancenameFLUOXETINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA202133Brand NameFLUOXETINE HCLGeneric NameFLUOXETINE HCLManufacturersAlmatica Pharma Inc.product_ndc52427-576Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFLUOXETINE HYDROCHLORIDERXCUI1190110spl_idbe947ac0-4be3-e37a-c8cd-de296c1514faspl_set_idb47b291f-3340-0c2a-3585-0926b9c1a71fPackage NDC52427-576-30UNIII9W7N6B1KJ

3)

drugcharacterization2medicinalproductXOPENEXdrugdosagetextUNKdrugstartdateformat102drugstartdate01/01/2015drugenddateformat102drugenddate01/02/2015

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

4)

drugcharacterization2medicinalproductASTELINdrugdosagetextUNKdrugdosageformSPRAYdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate15/07/2014

activesubstance

activesubstancenameAZELASTINE HYDROCHLORIDE

5)

drugcharacterization2medicinalproductSINGULAIRdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate22/01/2014

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

6)

drugcharacterization2medicinalproductXOPENEXdrugdosagetext0.63 MG/3 MLdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate13/10/2015

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

7)

drugcharacterization2medicinalproductYAZ 28drugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate13/10/2015

8)

drugcharacterization2medicinalproductFLUTICASONE PROPIONATE.drugdosagetextUNKdrugdosageformSPRAYdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate01/07/2015

activesubstance

activesubstancenameFLUTICASONE PROPIONATE

openFDA Info on Medication

Application Number ANDA208150, ANDA207957, NDA209022, ANDA077538, ANDA076793, ANDA076668, NDA205434 ... Brand Name FLUTICASONE PROPIONATE, HEALTH MART ALLERGY RELIEF NASAL 24 HR, FAMILY WELLNESS ... Generic NameFLUTICASONE PROPIONATEManufacturers Selder, S.A. de C.V., Strategic Sourcing Services LLC, Family Dollar Services In ... product_ndc 63654-380, 62011-0269, 55319-019, 46122-338, 64024-007, 69168-380, 41250-634, 71 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteNASAL, TOPICAL, RESPIRATORY (INHALATION)Active IngredientsFLUTICASONE PROPIONATERXCUI 1797907, 1946583, 1946589, 895987, 895487, 1797933, 2395835, 2395836, 2395837, 2 ... spl_id 02f8d90c-af45-4f40-a518-06578b811f96, a28513f3-8f39-4acf-a567-4017d2bd4e90, e22a ... spl_set_id 2da4ba91-c356-473d-b20c-5bb9265767df, 3a1096ec-6914-4a37-892b-761c89a6a87b, eb9c ... Package NDC 63654-380-01, 62011-0269-2, 62011-0269-1, 62011-0269-4, 62011-0269-3, 55319-019- ... UNIIO2GMZ0LF5W

9)

drugcharacterization2medicinalproductCLONAZEPAM.drugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate01/01/2015drugenddateformat102drugenddate01/10/2015

activesubstance

activesubstancenameCLONAZEPAM

openFDA Info on Medication

Application Number ANDA077194, ANDA077171, ANDA074569, ANDA077147, ANDA211033, ANDA077856, NDA01753 ... Brand NameCLONAZEPAM, KLONOPINGeneric NameCLONAZEPAMManufacturers Teva Pharmaceuticals USA, Inc., Par Pharmaceutical, Inc., Accord Healthcare Inc. ... product_ndc 0093-9290, 0093-9291, 0093-9292, 0093-9293, 0093-9294, 49884-306, 49884-307, 498 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONAZEPAMRXCUI 349194, 349195, 349196, 349197, 349198, 197527, 197528, 197529, 206157, 206159, ... spl_id 0a290597-0942-4e2e-bcf7-7486bf8b933e, a95f8799-0bb3-41d6-aa27-8a291127ad54, e7a6 ... spl_set_id cb2e209e-e69b-422b-8abb-34df2bc92caa, 1aef0069-80ea-483d-ac70-c8d485462c5b, 8069 ... Package NDC 0093-9290-67, 0093-9291-67, 0093-9292-67, 0093-9293-67, 0093-9294-67, 49884-306- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII5PE9FDE8GB

10)

drugcharacterization2medicinalproductNAPROXEN SODIUM.drugdosagetextUNKdrugdosageformCAPSULEdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate13/10/2015

activesubstance

activesubstancenameNAPROXEN SODIUM

openFDA Info on Medication

Application Number ANDA091353, ANDA075168, ANDA079096, ANDA208363, ANDA074661, NDA021920, ANDA20487 ... Brand Name NAPROXEN SODIUM, LIL DRUG STORE PAIN RELIEF ALL DAY, BASIC CARE NAPROXEN SODIUM, ... Generic Name NAPROXEN SODIUM, NAPROXEN SODIUM, COATED TABLETS, NAPROXEN SODIUM TABLET, COATED ... Manufacturers Family Dollar (FAMILY WELLNESS), Kroger Company, Lil' Drug Store Products, Inc., ... product_ndc 55319-255, 30142-954, 66715-9740, 11673-748, 0113-7368, 68196-368, 37012-368, 21 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive Ingredients NAPROXEN SODIUM, 2-NAPHTHALENEACETIC ACID, 6-METHOXY-.ALPHA.-METHYL-, SODIUM SAL ... RXCUI 849574, 1112231, 849728, 849398, 849431, 198012, 198013, 198014, 1608797, 159366 ... spl_id 16490a52-fb4a-4747-b11d-55fe1ef747f3, 0bdfb555-d1e3-4003-9a01-08bf4b8689be, c708 ... spl_set_id 285427dc-981b-495b-b8f0-632628ebead4, 30bcf289-0039-f389-73c4-fef3e8861034, 41d2 ... Package NDC 55319-255-01, 55319-255-24, 55319-255-50, 30142-954-10, 30142-954-20, 30142-954- ... UNII9TN87S3A3C, TC2D6JAD40, 57Y76R9ATQNUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]

11)

drugcharacterization2medicinalproductTRAZODONEdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate24/11/2014

activesubstance

activesubstancenameTRAZODONE HYDROCHLORIDE

openFDA Info on Medication

12)

drugcharacterization2medicinalproductEPINEPHRINE.drugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate22/01/2014

activesubstance

activesubstancenameEPINEPHRINE

openFDA Info on Medication

Brand Name EPINEPHRINE 1553, EPINEPHRINE, ADRENALIN, EPIPEN, EPIPEN JR, ADRENALINUM, AUVI-Q ... Generic NameEPINEPHRINE, ADRENALINUMManufacturers Professional Complementary Health Formulas, Belcher Pharmaceuticals, LLC, Intern ... product_ndc 63083-1553, 62250-103, 76329-3316, 76329-9060, 42023-168, 54288-120, 49502-500, ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUS, INTRACARDIAC, INTRAMUSCULAR, SUBCUTANEOUSActive IngredientsEPINEPHRINEspl_id fe8919ae-f489-464d-8b87-53657669b8bc, 0b5e145a-fe14-458c-b8b0-b54f63296c30, e6e7 ... spl_set_id c06d262b-b97e-4921-b927-c51e1b27691e, e51c9ca2-6057-4830-9dcc-e8c7491f861b, 353f ... Package NDC 63083-1553-1, 62250-103-10, 76329-3316-1, 76329-9060-0, 42023-168-99, 54288-120- ... NUIN0000000209, N0000000245, N0000175552, N0000175555, N0000175570, M0003647Mechanism of ActionAdrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA]Established Pharmacologic Class alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC], Catecholamine [EP ... Chemical StructureCatecholamines [CS]UNIIYKH834O4BHApplication Number NDA205029, ANDA211880, NDA204640, NDA019430, NDA020800, NDA201739, NDA204200, ND ... RXCUI 1660014, 727373, 310132, 1490057, 727316, 727347, 727386, 1870207, 1870225, 1870 ...

13)

drugcharacterization2medicinalproductDEPAKOTE ERdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate16/10/2010drugenddateformat102drugenddate16/10/2015

activesubstance

activesubstancenameDIVALPROEX SODIUM

openFDA Info on Medication

Application NumberNDA021168Brand NameDEPAKOTE ERGeneric NameDIVALPROEX SODIUMManufacturersAbbVie Inc.product_ndc0074-3826, 0074-7401, 0074-7126, 0074-7402Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsDIVALPROEX SODIUMRXCUI1099563, 1099565, 1099569, 1099571spl_id94b6d88a-6c23-4f4a-b3bd-3c8b451ffb43spl_set_id0dc024ce-efc8-4690-7cb5-639c728fccacPackage NDC 0074-3826-13, 0074-3826-11, 0074-7401-13, 0074-7126-13, 0074-7126-53, 0074-7126- ... UNII644VL95AO6

14)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugstructuredosagenumb4.5drugstructuredosageunit002drugdosagetext4.5 G, BIDdrugdosageformORAL SOLUTIONdrugstartdateformat610drugstartdate/06/2011drugenddateformat602drugenddate//2012actiondrug5

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

15)

drugcharacterization2medicinalproductZYRTECdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate15/01/2014

activesubstance

activesubstancenameCETIRIZINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA022429, NDA021621Brand NameZYRTECGeneric NameCETIRIZINE HYDROCHLORIDEManufacturersJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Divisionproduct_ndc50580-779, 50580-753Product TypeHUMAN OTC DRUGRouteORALActive IngredientsCETIRIZINE HYDROCHLORIDERXCUI1014675, 1020023, 1014674, 1020022spl_idcea20e63-c9ab-38c7-e053-2995a90adebe, dfe981c1-d2ce-2fbc-e053-2995a90ab14fspl_set_id605adf29-734f-451a-8ff3-74be7b5814a6, dc613bd5-70fd-1d9b-e053-2995a90a41cdPackage NDC50580-779-12, 50580-779-25, 50580-779-40, 50580-779-65, 50580-753-24UNII64O047KTOA

16)

drugcharacterization2medicinalproductLUNESTAdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate01/01/2001drugenddateformat102drugenddate17/10/2014

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

17)

drugcharacterization2medicinalproductZITHROMAXdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameAZITHROMYCIN DIHYDRATE

openFDA Info on Medication

Brand NameZITHROMAXGeneric NameAZITHROMYCIN DIHYDRATEManufacturersPfizer Laboratories Div Pfizer Incproduct_ndc 0069-9500, 0069-3060, 0069-3070, 0069-3110, 0069-3120, 0069-3130, 0069-3140, 006 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsAZITHROMYCIN DIHYDRATERXCUI 212446, 308460, 105260, 141963, 211307, 226827, 248656, 308459, 749780, 749783, ... spl_id 6ea307ee-5dc2-4ef8-9520-5dffec6a3e55, 26a7f105-ba25-4f60-938e-063be82dd5ff, baf6 ... spl_set_id fb3d03d8-c7c1-48c4-b5ac-91ed0398f0d2, db52b91e-79f7-4cc1-9564-f2eee8e31c45, 3b63 ... Package NDC 0069-9500-01, 0069-3060-30, 0069-3060-75, 0069-3060-86, 0069-3070-30, 0069-3070- ... UNII5FD1131I7SApplication NumberNDA050711, NDA050784, NDA050710, NDA050733, NDA050693

18)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugstructuredosagenumb9drugstructuredosageunit002drugdosagetext9 G, BIDdrugdosageformORAL SOLUTIONdrugadministrationroute048drugstartdateformat610drugstartdate/07/2010drugenddateformat602drugenddate//2011actiondrug5

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)

drugcharacterization2medicinalproductSYNTHROIDdrugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate13/10/2015

activesubstance

activesubstancenameLEVOTHYROXINE SODIUM

openFDA Info on Medication

Application NumberNDA021402Brand NameSYNTHROIDGeneric NameLEVOTHYROXINE SODIUMManufacturersAbbVie Inc.product_ndc 0074-3727, 0074-7149, 0074-4341, 0074-4552, 0074-5182, 0074-6624, 0074-6594, 007 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLEVOTHYROXINE SODIUMRXCUI 892246, 892251, 892255, 966158, 966171, 966185, 966191, 966201, 966205, 966218, ... spl_ided6f6960-2439-4bb0-bb7f-c7d05e4d37a5spl_set_id1e11ad30-1041-4520-10b0-8f9d30d30fccPackage NDC 0074-7149-90, 0074-7149-19, 0074-4341-13, 0074-4341-90, 0074-4341-19, 0074-4341- ... UNII9J765S329G

20)

drugcharacterization2medicinalproductADVAIR HFAdrugdosagetext45-21 MCGdrugdosageformINHALERdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate22/01/2014

activesubstance

activesubstancenameFLUTICASONE PROPIONATE\SALMETEROL XINAFOATE

openFDA Info on Medication

Application NumberNDA021254Brand NameADVAIR HFAGeneric NameFLUTICASONE PROPIONATE AND SALMETEROL XINAFOATEManufacturersGlaxoSmithKline LLCproduct_ndc0173-0715, 0173-0716, 0173-0717Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsFLUTICASONE PROPIONATE, SALMETEROL XINAFOATERXCUI 896231, 896235, 896236, 896237, 896239, 896243, 896244, 896245, 896267, 896271, ... spl_id717071a8-e206-47f6-8e3f-c395d532ebd3spl_set_iddfaca6f9-3277-47b2-319d-1377917cb54cPackage NDC 0173-0715-20, 0173-0715-22, 0173-0716-20, 0173-0716-22, 0173-0717-20, 0173-0717- ... UNII6EW8Q962A5, O2GMZ0LF5W

21)

drugcharacterization2medicinalproductVITAMIN D2drugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate22/01/2014drugrecurreadministration3

activesubstance

activesubstancenameERGOCALCIFEROL

openFDA Info on Medication

Application NumberANDA090455Brand NameVITAMIN DGeneric NameERGOCALCIFEROLManufacturers Strides Pharma Science Limited, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmac ... product_ndc64380-737, 23155-809Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsERGOCALCIFEROLRXCUI1367410spl_id08a99dff-5765-49b0-b289-4e854d3c6725, 9c09c2d2-ef29-4654-be7d-ed3b2b508f43spl_set_id2c4c0a36-12cf-444d-9d57-de983eef4d36, 96da2c1e-6c5e-4df0-8166-3de53c08a701Package NDC64380-737-06, 64380-737-25, 23155-809-01NUIM0007651, N0000175909Chemical StructureErgocalciferols [CS]Established Pharmacologic ClassProvitamin D2 Compound [EPC]UNIIVS041H42XC

22)

drugcharacterization2medicinalproductACCOLATEdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate16/10/2005drugenddateformat102drugenddate16/10/2015

activesubstance

activesubstancenameZAFIRLUKAST

openFDA Info on Medication

Application NumberNDA020547Brand NameACCOLATEGeneric NameZAFIRLUKASTManufacturersPar Pharmaceutical, Inc.product_ndc49884-589, 49884-590Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsZAFIRLUKASTRXCUI199655, 211776, 261313, 313758spl_id86871a45-8c7f-46fe-9a01-5f5fbe9e32ccspl_set_idd31ecca3-23ff-470e-8c91-1bea8a537b3cPackage NDC49884-589-02, 49884-590-02NUIN0000175777, N0000000083, N0000185504Established Pharmacologic ClassLeukotriene Receptor Antagonist [EPC]Mechanism of ActionLeukotriene Receptor Antagonists [MoA], Cytochrome P450 2C9 Inhibitors [MoA]UNIIXZ629S5L50

23)

drugcharacterization2medicinalproductPULMICORT TURBUHALERdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate01/01/2005

activesubstance

activesubstancenameBUDESONIDE

24)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugstructuredosagenumb4.5drugstructuredosageunit002drugdosagetext4.5 G, BIDdrugdosageformORAL SOLUTIONdrugstartdateformat610drugstartdate/08/2014actiondrug5

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)

drugcharacterization2medicinalproductPREDNISONE.drugdosagetextUNKdrugdosageformTABLETdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate15/07/2014

activesubstance

activesubstancenamePREDNISONE

openFDA Info on Medication

Application Number NDA202020, ANDA215246, ANDA211496, ANDA080292, ANDA088832, ANDA083677, ANDA04058 ... Brand NameRAYOS, PREDNISONEGeneric NamePREDNISONEManufacturers Horizon Therapeutics USA, Inc., Novitium Pharma LLC, GeneYork Pharmaceuticals Gr ... product_ndc 75987-020, 75987-021, 75987-022, 70954-056, 71329-106, 0378-0640, 0378-0641, 037 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPREDNISONERXCUI 1303125, 1303131, 1303132, 1303134, 1303135, 1303137, 198144, 198145, 312615, 31 ... spl_id 96a17428-b512-4fd9-a64d-50160d22aaaa, 7335a293-992b-490c-ab8a-66a7ca1eea30, 4384 ... spl_set_id 281ab967-7565-4bef-9c0c-a646589c671e, 7335a293-992b-490c-ab8a-66a7ca1eea30, be50 ... Package NDC 75987-020-02, 75987-020-01, 75987-020-70, 75987-021-02, 75987-021-01, 75987-021- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIVB0R961HZT

26)

drugcharacterization2medicinalproductTYLENOL EXTRA STRENGTHdrugdosagetextUNKdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate22/01/2014

activesubstance

activesubstancenameACETAMINOPHEN

openFDA Info on Medication

Application Numberpart343Brand NameTYLENOL EXTRA STRENGTH, TYLENOL EXTRA STRENGTH CAPLETGeneric NameACETAMINOPHENManufacturers Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, Lil' Drug ... product_ndc 50580-490, 50580-937, 50580-451, 66715-9747, 50580-378, 50580-209, 50580-590, 50 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsACETAMINOPHENRXCUI198440, 209459, 2374360, 2374361spl_id da41f11b-dc52-0389-e053-2a95a90a846f, 855f7a57-20a0-4a4a-84e1-67851f0245f0, dfd7 ... spl_set_id 201b860d-dc3c-4380-affa-e757bf2103cf, 103d109d-f520-409c-8da2-eb6b0fbec891, bb65 ... Package NDC 50580-490-24, 50580-490-50, 50580-490-10, 50580-490-25, 50580-490-90, 50580-937- ... UNII362O9ITL9D

27)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugstructuredosagenumb4.5drugstructuredosageunit002drugdosagetext4.5 G, BIDdrugdosageformORAL SOLUTIONdrugadministrationroute048drugindicationNARCOLEPSYdrugstartdateformat610drugstartdate/08/2009drugenddateformat602drugenddate//2010actiondrug5

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

28)

drugcharacterization1medicinalproductXYREMdrugauthorizationnumb021196drugstructuredosagenumb9drugstructuredosageunit002drugdosagetext9 G, BIDdrugdosageformORAL SOLUTIONdrugstartdateformat610drugstartdate/07/2012drugenddateformat602drugenddate//2012actiondrug5

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