Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10548962primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate29/05/2015reporttype2serious1seriousnessother1receivedateformat102Date Received28/10/2014receiptdateformat102Date Last Updated28/10/2014fulfillexpeditecriteria1companynumbUS-MYLANLABS-2014M1008647duplicate1

Report Duplicate

duplicatesourceMYLANduplicatenumbUS-MYLANLABS-2014M1008647

Primary Source

reportercountryUSqualification3literaturereference WALKER MJ, WEBSTER LR. OPIOID-INDUCED HYPERALGESIA AND MONOTHERAPY INTRATHECAL Z ...

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Reaction

1)

reactionmeddraversionpt18.0ReactionImpaired gastric emptyingOutcomeUnknown

2)

reactionmeddraversionpt18.0ReactionConfusional stateOutcomeRecovered/resolved

3)

reactionmeddraversionpt18.0ReactionUrinary retentionOutcomeRecovered/resolved

4)

reactionmeddraversionpt18.0ReactionSyncopeOutcomeRecovered/resolved

5)

reactionmeddraversionpt18.0ReactionNauseaOutcomeRecovered/resolved

6)

reactionmeddraversionpt18.0ReactionVomitingOutcomeRecovered/resolved

7)

reactionmeddraversionpt18.0ReactionHyperaesthesiaOutcomeRecovering/resolving

8)

reactionmeddraversionpt18.0ReactionMental status changesOutcomeRecovered/resolved

9)

reactionmeddraversionpt18.0ReactionInsomniaOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductZICONOTIDEdrugdosagetext0.25 MICROG/DAY BOLUSdrugadministrationroute065actiondrug2drugrecurreadministration3

activesubstance

activesubstancenameZICONOTIDE

openFDA Info on Medication

Application NumberNDA021060Brand NamePRIALTGeneric NameZICONOTIDEManufacturersJazz Pharmaceuticals, Inc.product_ndc18860-720, 18860-723, 18860-722Product TypeHUMAN PRESCRIPTION DRUGRouteINTRATHECALActive IngredientsZICONOTIDE ACETATERXCUI486133, 583453, 1738353, 1738354, 1738357, 1738358spl_ide1eaf98c-712f-4253-80e9-7e6f41b7e212spl_set_id5449ca98-efb8-4c3b-8756-747b2349a472Package NDC18860-723-10, 18860-723-05, 18860-720-10, 18860-722-10UNIIT2I226K69M

2)

drugcharacterization2medicinalproductCLONAZEPAM.drugadministrationroute048drugindicationPAINactiondrug1drugrecurreadministration3

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

3)

drugcharacterization2medicinalproductFROVATRIPTANdrugadministrationroute048drugindicationPAINactiondrug1drugrecurreadministration3

activesubstance

activesubstancenameFROVATRIPTAN

openFDA Info on Medication

Application NumberANDA211292, ANDA202931Brand NameFROVATRIPTANGeneric NameFROVATRIPTAN SUCCINATE, FROVATRIPTANManufacturersAmneal Pharmaceuticals NY LLC, Mylan Pharmaceuticals Inc.product_ndc69238-1539, 0378-3140Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFROVATRIPTAN SUCCINATERXCUI349462spl_idd9a6b263-23ac-4953-9c41-5377abb3386d, d81310e4-d6a6-435e-a91a-582662eb69cespl_set_id94b996dc-ddc4-41ce-9a9f-3d91cb187473, 626483a8-a543-4183-99bd-7293767881adPackage NDC69238-1539-9, 0378-3140-32, 0378-3140-85UNIID28J6W18HY

4)

drugcharacterization2medicinalproductPROMETHAZINEdrugadministrationroute048drugindicationPAINactiondrug1drugrecurreadministration3

activesubstance

activesubstancenamePROMETHAZINE\PROMETHAZINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA040882Brand NamePROMETHAZINE HYDROCHLORIDEGeneric NamePROMETHAZINEManufacturersAmneal Pharmaceuticals LLCproduct_ndc65162-678Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsPROMETHAZINE HYDROCHLORIDERXCUI992432spl_id43553934-cb17-455f-bb9a-3f44b9da0cbbspl_set_idafb16e94-03bf-4ea2-b2fe-e65f274e55a9Package NDC65162-678-86, 65162-678-90UNIIR61ZEH7I1I

5)

drugcharacterization1medicinalproductHYDROMORPHONEdrugstructuredosagenumb17drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext17 MG, QDdrugadministrationroute037actiondrug1drugrecurreadministration3

activesubstance

activesubstancenameHYDROMORPHONE

6)

drugcharacterization2medicinalproductALPRAZOLAM.drugadministrationroute048drugindicationPAINactiondrug1drugrecurreadministration3

activesubstance

activesubstancenameALPRAZOLAM

openFDA Info on Medication

Application Number ANDA207507, ANDA074342, NDA021434, ANDA203346, ANDA090871, NDA018276, ANDA074174 ... Brand NameALPRAZOLAM, XANAX XR, ALPRAZOLAM EXTENDED RELEASE, XANAX, ALPRAZOLAM XRGeneric NameALPRAZOLAMManufacturers Breckenridge Pharmaceutical, Inc., Actavis Pharma, Inc., Pharmacia & Upjohn Comp ... product_ndc 51991-704, 51991-705, 51991-706, 51991-707, 0228-2027, 0228-2029, 0228-2031, 022 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsALPRAZOLAMRXCUI 197321, 197322, 308047, 308048, 433798, 433799, 433800, 433801, 687022, 687023, ... spl_id 94163352-f78e-400a-b7da-b3075e9213eb, 35398b0f-4f2a-4504-b254-bb6010a4101e, f364 ... spl_set_id 67f66894-addc-4e92-855a-c9ae03a5c2c5, a23063c0-099a-4256-b95f-3a857bbf704b, aa58 ... Package NDC 51991-704-01, 51991-704-05, 51991-704-10, 51991-705-01, 51991-705-05, 51991-705- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIYU55MQ3IZY

7)

drugcharacterization2medicinalproductELETRIPTANdrugadministrationroute048drugindicationPAINactiondrug1drugrecurreadministration3

activesubstance

activesubstancenameELETRIPTAN

openFDA Info on Medication

Application NumberNDA021016Brand NameELETRIPTANGeneric NameELETRIPTAN HYDROBROMIDEManufacturersGreenstone LLCproduct_ndc59762-2321, 59762-2322Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsELETRIPTAN HYDROBROMIDERXCUI359493, 359494spl_ide1db233f-7b92-4130-9dfa-8927a81d2f51spl_set_id945285e3-b721-4c9d-9cab-b0615e0602bePackage NDC59762-2321-1, 59762-2322-1UNIIM41W832TA3

8)

drugcharacterization2medicinalproductDIAZEPAM.drugadministrationroute048drugindicationPAINactiondrug1drugrecurreadministration3

activesubstance

activesubstancenameDIAZEPAM

openFDA Info on Medication

Application Number ANDA072079, NDA020124, ANDA210363, NDA020648, NDA211635, NDA013263, ANDA071583, ... Brand NameDIAZEPAM, DIASTAT, VALTOCO, VALIUMGeneric NameDIAZEPAMManufacturers Hospira, Inc., Meridian Medical Technologies LLC, Dash Pharmaceuticals LLC, Baus ... product_ndc 0409-1273, 11704-600, 69339-136, 66490-650, 68682-650, 68682-652, 68682-655, 722 ... Product TypeHUMAN PRESCRIPTION DRUGRouteINTRAMUSCULAR, INTRAVENOUS, RECTAL, NASAL, ORALActive IngredientsDIAZEPAMRXCUI 1807459, 1807452, 2120550, 801957, 801958, 801961, 801966, 2272613, 2272619, 227 ... spl_id 14233fc1-606a-4e78-8da4-df9eedb1c793, 512dee3e-2c4c-4436-b92b-67113989cca5, 5b08 ... spl_set_id 41044928-dd1f-40bf-1fa6-709dff559124, fa352464-14c8-49e9-b8b7-5a968b1cfa93, 6b8d ... Package NDC 0409-1273-03, 0409-1273-32, 11704-600-01, 69339-136-02, 69339-136-32, 69339-136- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIQ3JTX2Q7TU

9)

drugcharacterization1medicinalproductHYDROMORPHONEdrugadministrationroute048drugindicationPAINactiondrug1drugrecurreadministration3

activesubstance

activesubstancenameHYDROMORPHONE

10)

drugcharacterization1medicinalproductZICONOTIDEdrugstructuredosagenumb1.2drugstructuredosageunit004drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1.2 ?G, QDdrugadministrationroute037drugindicationPAINactiondrug2drugrecurreadministration3

activesubstance

activesubstancenameZICONOTIDE

openFDA Info on Medication

Application NumberNDA021060Brand NamePRIALTGeneric NameZICONOTIDEManufacturersJazz Pharmaceuticals, Inc.product_ndc18860-720, 18860-723, 18860-722Product TypeHUMAN PRESCRIPTION DRUGRouteINTRATHECALActive IngredientsZICONOTIDE ACETATERXCUI486133, 583453, 1738353, 1738354, 1738357, 1738358spl_ide1eaf98c-712f-4253-80e9-7e6f41b7e212spl_set_id5449ca98-efb8-4c3b-8756-747b2349a472Package NDC18860-723-10, 18860-723-05, 18860-720-10, 18860-722-10UNIIT2I226K69M

11)

drugcharacterization2medicinalproductBACLOFEN.drugadministrationroute048drugindicationPAINactiondrug1drugrecurreadministration3

activesubstance

activesubstancenameBACLOFEN

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA209102, ANDA215885, ANDA209594, ANDA074584, ANDA2100 ... Brand NameBACLOFEN, BACLOFEN (INTRATHECAL), LYVISPAH, OZOBAX, FLEQSUVYGeneric NameBACLOFENManufacturers Northstar RxLLC, TruPharma LLC, Lifestar Pharma LLC, Mylan Institutional LLC, Up ... product_ndc 16714-071, 16714-072, 52817-319, 52817-320, 52817-321, 70756-085, 70756-288, 707 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 430902, 1300890, 308517, 1666613, 2586589, 2586595, 2586596, 258 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, b8da4a75-4c34-1d06-e053-2a95a90a7886, f4a6 ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 68aa591e-ea98-4438-9a4a-4f7e9ea2b285, f9dd ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 52817-319-10, 52817-320- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

12)

drugcharacterization2medicinalproductESZOPICLONE.drugadministrationroute048drugindicationPAINactiondrug1drugrecurreadministration3

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

13)

drugcharacterization2medicinalproductCLONIDINE.drugstructuredosagenumb133drugstructuredosageunit004drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext133 ?G, QDdrugadministrationroute037drugindicationPAINactiondrug1drugrecurreadministration3

activesubstance

activesubstancenameCLONIDINE

openFDA Info on Medication

Application Number ANDA076166, ANDA209675, ANDA210052, NDA018891, ANDA203167, NDA022500, ANDA090873 ... Brand Name CLONIDINE, CLONIDINE HYDROCHLORIDE, CATAPRES-TTS-1, CATAPRES-TTS-2, CATAPRES-TTS ... Generic NameCLONIDINEManufacturers Mylan Pharmaceuticals Inc., Ingenus Pharmaceuticals, LLC, Amneal Pharmaceuticals ... product_ndc 0378-0871, 0378-0872, 0378-0873, 50742-247, 69238-1426, 82089-101, 82089-102, 82 ... Product TypeHUMAN PRESCRIPTION DRUGRouteTRANSDERMAL, ORAL, EPIDURALActive IngredientsCLONIDINE, CLONIDINE HYDROCHLORIDERXCUI 998671, 998675, 998679, 1013930, 998673, 998677, 998681, 884221, 884225, 885880, ... spl_id c140d273-d4f3-444b-95b0-7aa0edd32b58, c48928af-0077-4c1b-b428-8c00237c3aa0, cec4 ... spl_set_id 7adfc439-e6d0-4593-87dd-0eef36d33c6d, 99485427-a120-4fc7-bb61-25857d1900ec, accb ... Package NDC 0378-0871-16, 0378-0871-99, 0378-0872-16, 0378-0872-99, 0378-0873-16, 0378-0873- ... NUIN0000009918, N0000175554Mechanism of ActionAdrenergic alpha2-Agonists [MoA]Established Pharmacologic ClassCentral alpha-2 Adrenergic Agonist [EPC]UNIIMN3L5RMN02, W76I6XXF06

14)

drugcharacterization2medicinalproductBACLOFEN.drugstructuredosagenumb400drugstructuredosageunit004drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext400 ?G, QDdrugadministrationroute037actiondrug1drugrecurreadministration3

activesubstance

activesubstancenameBACLOFEN

openFDA Info on Medication

Application Number ANDA078504, ANDA078401, ANDA209102, ANDA215885, ANDA209594, ANDA074584, ANDA2100 ... Brand NameBACLOFEN, BACLOFEN (INTRATHECAL), LYVISPAH, OZOBAX, FLEQSUVYGeneric NameBACLOFENManufacturers Northstar RxLLC, TruPharma LLC, Lifestar Pharma LLC, Mylan Institutional LLC, Up ... product_ndc 16714-071, 16714-072, 52817-319, 52817-320, 52817-321, 70756-085, 70756-288, 707 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRATHECALActive IngredientsBACLOFENRXCUI 197391, 197392, 430902, 1300890, 308517, 1666613, 2586589, 2586595, 2586596, 258 ... spl_id 860b4535-9619-47b7-97d5-910f8b22c7e9, b8da4a75-4c34-1d06-e053-2a95a90a7886, f4a6 ... spl_set_id 0aac77fa-30c2-46c8-a04d-e6b8333ddd81, 68aa591e-ea98-4438-9a4a-4f7e9ea2b285, f9dd ... Package NDC 16714-071-04, 16714-071-06, 16714-072-04, 16714-072-05, 52817-319-10, 52817-320- ... NUIN0000000196, N0000000116, N0000175759Mechanism of ActionGABA A Agonists [MoA], GABA B Agonists [MoA]Established Pharmacologic Classgamma-Aminobutyric Acid-ergic Agonist [EPC]UNIIH789N3FKE8

15)

drugcharacterization1medicinalproductSUFENTANILdrugstructuredosagenumb7drugstructuredosageunit004drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext7 ?G, QDdrugadministrationroute037drugindicationPAINactiondrug1drugrecurreadministration3

activesubstance

activesubstancenameSUFENTANIL

openFDA Info on Medication

Application NumberNDA209128Brand NameDSUVIAGeneric NameSUFENTANILManufacturersAcelRx Pharmaceuticals, Incproduct_ndc61621-430Product TypeHUMAN PRESCRIPTION DRUGRouteSUBLINGUALActive IngredientsSUFENTANILRXCUI2103192, 2103199spl_id64d49a11-5597-4c89-aeea-ab6d2606ea7espl_set_id8b580f3d-e3b5-4086-b093-87a980631147Package NDC61621-430-11, 61621-430-01NUIN0000175684, N0000175690Mechanism of ActionFull Opioid Agonists [MoA]Established Pharmacologic ClassOpioid Agonist [EPC]UNIIAFE2YW0IIZ

16)

drugcharacterization1medicinalproductZICONOTIDEdrugstructuredosagenumb2.2drugstructuredosageunit004drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2.2 ?G, QDdrugadministrationroute037actiondrug2drugrecurreadministration3

activesubstance

activesubstancenameZICONOTIDE

openFDA Info on Medication

Application NumberNDA021060Brand NamePRIALTGeneric NameZICONOTIDEManufacturersJazz Pharmaceuticals, Inc.product_ndc18860-720, 18860-723, 18860-722Product TypeHUMAN PRESCRIPTION DRUGRouteINTRATHECALActive IngredientsZICONOTIDE ACETATERXCUI486133, 583453, 1738353, 1738354, 1738357, 1738358spl_ide1eaf98c-712f-4253-80e9-7e6f41b7e212spl_set_id5449ca98-efb8-4c3b-8756-747b2349a472Package NDC18860-723-10, 18860-723-05, 18860-720-10, 18860-722-10UNIIT2I226K69M

17)

drugcharacterization2medicinalproductZOLPIDEMdrugadministrationroute048drugindicationPAINactiondrug1drugrecurreadministration3

activesubstance

activesubstancenameZOLPIDEM\ZOLPIDEM TARTRATE

openFDA Info on Medication

Application NumberANDA077214Brand NameZOLPIDEMGeneric NameZOLPIDEM TARTRATEManufacturersACI Healthcare USA, Incproduct_ndc71093-155, 71093-156Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsZOLPIDEM TARTRATERXCUI854873, 854876spl_ide4a5e984-a50b-4f1e-a50d-b1acd2b34d52spl_set_id021153ce-fe27-4ed1-8d88-b4157b0ed734Package NDC71093-155-06, 71093-155-04, 71093-156-04, 71093-156-06UNIIWY6W63843K

18)

drugcharacterization2medicinalproductCELECOXIB.drugadministrationroute048drugindicationPAINactiondrug1drugrecurreadministration3

activesubstance

activesubstancenameCELECOXIB

openFDA Info on Medication

Application Number ANDA206827, ANDA202240, ANDA208701, ANDA210071, ANDA213598, ANDA078857, ANDA2070 ... Brand NameCELECOXIB, GENERIC DRUG, CELEBREX, ELYXYB - CELECOXIBGeneric NameCELECOXIBManufacturers Aurobindo Pharma Limited, Lupin Pharmaceuticals, Inc., Modavar Pharmaceuticals L ... product_ndc 65862-907, 65862-908, 65862-909, 65862-910, 68180-395, 68180-396, 68180-397, 681 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCELECOXIBRXCUI205322, 205323, 349514, 686379, 213468, 213469, 352314, 686381, 2373454, 2373460spl_id 1992870d-994a-4db4-97b6-be46e6f68182, 64af7d57-a662-4efd-8180-26e3023170b0, 0d1e ... spl_set_id 1e811c3a-5653-4617-b958-380802cc443a, 560017b1-daf8-464e-b86f-0a75c78002ec, b0f7 ... Package NDC 65862-907-60, 65862-907-99, 65862-908-01, 65862-908-05, 65862-908-99, 65862-909- ... NUIN0000000160, M0001335, N0000175722Mechanism of ActionCyclooxygenase Inhibitors [MoA]Chemical StructureAnti-Inflammatory Agents, Non-Steroidal [CS]Established Pharmacologic ClassNonsteroidal Anti-inflammatory Drug [EPC]UNIIJCX84Q7J1L

19)

drugcharacterization2medicinalproductA.C.CAPdrugadministrationroute048drugindicationPAINactiondrug1drugrecurreadministration3

20)

drugcharacterization2medicinalproductBUPIVACAINEdrugstructuredosagenumb5.3drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext5.3 MG, QDdrugadministrationroute037drugindicationPAINactiondrug1drugrecurreadministration3

activesubstance

activesubstancenameBUPIVACAINE

openFDA Info on Medication

Application NumberNDA022496, NDA204803, ANDA071810Brand NameEXPAREL, POSIMIR, BUPIVACAINE SPINALGeneric NameBUPIVACAINE, BUPIVACAINE HYDROCHLORIDE IN DEXTROSEManufacturersPacira Pharmaceuticals Inc., INNOCOLL PHARMACEUTICALS, Hospira, Inc.product_ndc65250-133, 65250-266, 51715-660, 0409-3613Product TypeHUMAN PRESCRIPTION DRUGRouteINFILTRATION, SUBARACHNOIDActive IngredientsBUPIVACAINE, BUPIVACAINE HYDROCHLORIDERXCUI1191508, 1191513, 1745061, 1745062, 2563412, 2563417, 1724784spl_id 81cc14bb-aff7-4bde-aafe-1e7d32c5b7e0, f23d31d1-c3dc-4839-95eb-c4aea94ba082, e143 ... spl_set_id bb5a9e59-0f51-11df-8a39-0800200c9a66, dbc4df8d-62ba-4893-9c0c-90cbc4c4ca39, 7a8d ... Package NDC 65250-133-10, 65250-133-09, 65250-133-04, 65250-266-20, 65250-266-09, 65250-266- ... NUIN0000175682, M0000897, N0000175976Established Pharmacologic ClassAmide Local Anesthetic [EPC]Chemical StructureAmides [CS]Physiologic/Pharmacodynamic EffectLocal Anesthesia [PE]UNIIY8335394RO, 7TQO7W3VT8

21)

drugcharacterization1medicinalproductFENTANYL.drugauthorizationnumb076258drugdosageformTRANSDERMAL PATCHdrugadministrationroute062drugindicationPAINactiondrug1drugrecurreadministration3

activesubstance

activesubstancenameFENTANYL

openFDA Info on Medication

Application NumberNDA022569, NDA202788, ANDA202097, ANDA077449, NDA021947, NDA019813, ANDA076258Brand NameLAZANDA, SUBSYS, FENTANYL SYSTEM, FENTANYL, FENTORA, DURAGESIC (FENTANYL SYSTEM)Generic NameFENTANYLManufacturers West Therapeutic Development LLC, West Therapeutics Development, LLC, Alvogen, A ... product_ndc 71500-110, 71500-140, 71500-130, 71500-001, 71500-002, 71500-004, 71500-006, 715 ... Product TypeHUMAN PRESCRIPTION DRUGRouteNASAL, SUBLINGUAL, TRANSDERMAL, BUCCALActive IngredientsFENTANYL CITRATE, FENTANYLRXCUI 1115573, 1115575, 1115577, 1115579, 1729320, 1729322, 1237050, 1237055, 1237057, ... spl_id be24d79a-2287-2b3a-e053-2a95a90a8243, c10a64fb-0dc8-b077-e053-2995a90a374f, d22b ... spl_set_id 73f38bde-2132-2b5a-e053-2a91aa0a6efb, be7670d5-b88a-13bd-e053-2995a90a2f78, 2427 ... Package NDC 71500-140-01, 71500-130-01, 71500-110-01, 71500-001-10, 71500-002-30, 71500-004- ... UNIIMUN5LYG46H, UF599785JZNUIN0000175684, N0000175690Mechanism of ActionFull Opioid Agonists [MoA]Established Pharmacologic ClassOpioid Agonist [EPC]

22)

drugcharacterization1medicinalproductOXYCODONEdrugadministrationroute048drugindicationPAINactiondrug1drugrecurreadministration3

activesubstance

activesubstancenameOXYCODONE

openFDA Info on Medication

Application NumberANDA203638, NDA208090, ANDA211748, ANDA211749Brand NameOXYCODONE HYDROCHLORIDE, XTAMPZA ER, OXYCODONEGeneric NameOXYCODONEManufacturers Amneal Pharmaceuticals LLC, Collegium Pharmaceutical, Inc., Ascend Laboratories, ... product_ndc 65162-047, 65162-048, 65162-049, 65162-050, 65162-051, 24510-110, 24510-115, 245 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsOXYCODONE HYDROCHLORIDE, OXYCODONERXCUI 1049611, 1049618, 1049621, 1049683, 1049686, 1790527, 1790533, 1791558, 1791560, ... spl_id 65642e87-702d-404b-9d4c-816f116c7664, 1f9ccc6c-e3be-4e4b-a5e0-cfdf69253a2b, d906 ... spl_set_id 094b64b3-cd32-4de5-afb6-ea00d9caad74, b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c, 08b2 ... Package NDC 65162-047-03, 65162-047-10, 65162-047-25, 65162-047-50, 65162-048-03, 65162-048- ... UNIIC1ENJ2TE6C, CD35PMG570NUIN0000175684, N0000175690Mechanism of ActionFull Opioid Agonists [MoA]Established Pharmacologic ClassOpioid Agonist [EPC]