Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID11304526primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate25/11/2015reporttype1serious2receivedateformat102Date Received23/07/2015receiptdateformat102Date Last Updated23/07/2015fulfillexpeditecriteria2companynumbUS-JNJFOC-20140402693duplicate1

Report Duplicate

duplicatesourceJANSSENduplicatenumbUS-JNJFOC-20140402693

Primary Source

reportercountryUSqualification1literaturereference VERMA R, DELFANIAN K. BLASTOCYSTIS HOMINIS ASSOCIATED ACUTE URTICARIA. THE AMERI ...

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age71Unit of Onset Ageyearspatientagegroup6SexMale

Reaction

1)

reactionmeddraversionpt18.1ReactionUrticariaOutcomeRecovered/resolved

2)

reactionmeddraversionpt18.1ReactionDrug ineffectiveOutcomeUnknown

Drug

1)

drugcharacterization2medicinalproductESZOPICLONE.drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug1

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

2)

drugcharacterization2medicinalproductMETRONIDAZOLE.drugstructuredosagenumb750drugstructuredosageunit003drugseparatedosagenumb3drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformTABLETdrugadministrationroute048drugindicationRASHactiondrug1

activesubstance

activesubstancenameMETRONIDAZOLE

openFDA Info on Medication

Application Number ANDA077264, ANDA077549, ANDA070772, NDA020208, NDA018657, ANDA070027, ANDA070033 ... Brand Name METRONIDAZOLE, ROSADAN, FLAGYL, METRONIDAZOLE TOPICAL GEL, NUVESSA, VANDAZOLE, M ... Generic NameMETRONIDAZOLEManufacturers Sandoz Inc., Cosette Pharmaceuticals, Inc., AMICI PHARMACEUTICALS LLC, Oceanside ... product_ndc 0781-7077, 0713-0757, 69292-208, 68682-455, 0338-1055, 50111-333, 50111-334, 516 ... Product TypeHUMAN PRESCRIPTION DRUGRouteVAGINAL, TOPICAL, ORAL, INTRAVENOUSActive IngredientsMETRONIDAZOLERXCUI 142046, 311678, 311681, 311683, 314106, 311679, 199055, 1148398, 636559, 1251688 ... spl_id a00b814a-ba5f-4af8-b50d-fa231339148b, dde311f0-0ed9-e416-e053-2a95a90a860b, 986f ... spl_set_id 0030514f-879d-416d-b422-24b67e334b36, 5a7065b2-e729-46d5-8da5-865dc1ea58f7, 9f1f ... Package NDC 0781-7077-87, 0713-0757-37, 69292-208-01, 69292-208-50, 68682-455-70, 0338-1055- ... NUIN0000175435, M0014907Established Pharmacologic ClassNitroimidazole Antimicrobial [EPC]Chemical StructureNitroimidazoles [CS]UNII140QMO216E

3)

drugcharacterization2medicinalproductMULTIVITAMINSdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug1

activesubstance

activesubstancenameVITAMINS

4)

drugcharacterization2medicinalproductLEVOTHYROXINE.drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug1

activesubstance

activesubstancenameLEVOTHYROXINE

openFDA Info on Medication

Brand NameLEVOTHYROXINEGeneric NameLEVOTHYROXINEManufacturersDeseret Biologicals, Inc.product_ndc43742-0955Product TypeHUMAN OTC DRUGRouteORALActive IngredientsLEVOTHYROXINEspl_id7c431149-4f46-4c4f-a5bb-c1b1fb705283spl_set_id1a467f8b-2611-4936-af2b-098e4791d6aePackage NDC43742-0955-1NUIN0000175945, M0021504Established Pharmacologic Classl-Thyroxine [EPC]Chemical StructureThyroxine [CS]UNIIQ51BO43MG4

5)

drugcharacterization2medicinalproductOMEGA 3 FATTY ACIDdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug1

activesubstance

activesubstancenameOMEGA-3 FATTY ACIDS

6)

drugcharacterization2medicinalproductALPRAZOLAM.drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug1

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)

drugcharacterization2medicinalproductMETFORMINdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug1

activesubstance

activesubstancenameMETFORMIN HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA200690, ANDA209674, ANDA209313Brand NameMETFORMIN HYDROCHLORIDE, METFORMINGeneric NameMETFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MGManufacturers Mylan Pharmaceuticals Inc., Ingenus Pharmaceuticals, LLC, Granules Pharmaceutica ... product_ndc0378-6001, 0378-6002, 50742-633, 50742-634, 70010-491, 70010-492Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETFORMIN HYDROCHLORIDERXCUI1807894, 1807917, 860975, 860981spl_id b1d71739-26c3-43d3-9088-60bef3689e74, d7e2ad60-7a17-4c65-b836-e56644be754d, d164 ... spl_set_id 7e41818c-60e9-4bcf-9586-7bb8d33d5e89, 49a0b5c2-ebaf-4c4c-905f-dfd1962ac647, 6d6e ... Package NDC 0378-6002-91, 0378-6001-91, 50742-633-60, 50742-633-90, 50742-633-10, 50742-634- ... UNII786Z46389E

8)

drugcharacterization1medicinalproductCETIRIZINE HYDROCHLORIDE.drugauthorizationnumb019835drugdosageformUNSPECIFIEDdrugadministrationroute065actiondrug1drugrecurreadministration3

activesubstance

activesubstancenameCETIRIZINE HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA090760, NDA022429, ANDA207235, ANDA078336, ANDA077946, ANDA090750, ANDA09025 ... Brand Name CETIRIZINE HYDROCHLORIDE (ALLERGY), ZYRTEC, CAREONE ALLERGY RELIEF, DG HEALTH AL ... Generic Name CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZI ... Manufacturers 7-Eleven, Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, ... product_ndc 10202-715, 50580-779, 41520-715, 55910-458, 0113-7002, 0781-1683, 63868-865, 553 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsCETIRIZINE HYDROCHLORIDERXCUI 1014678, 1014675, 1020023, 1014676, 1014673, 1011482, 1014674, 1020022, 1014643, ... spl_id 429b73d2-5306-4792-9576-91ff3cc45f8e, cea20e63-c9ab-38c7-e053-2995a90adebe, ee2f ... spl_set_id 429b73d2-5306-4792-9576-91ff3cc45f8e, 605adf29-734f-451a-8ff3-74be7b5814a6, 833e ... Package NDC 10202-715-01, 50580-779-12, 50580-779-25, 50580-779-40, 50580-779-65, 41520-715- ... UNII64O047KTOA

9)

drugcharacterization2medicinalproductEMOLLIENTSactiondrug4

activesubstance

activesubstancenameEMOLLIENTS

openFDA Info on Medication

Brand NamePOLEN NATURAL AFTER CAREGeneric NameEMOLLIENTSManufacturersV5 Concrete Ltd.product_ndc81859-001Product TypeHUMAN OTC DRUGRouteTOPICALActive IngredientsALOEspl_idc07f6ed5-a5f5-94ba-e053-2a95a90a24e7spl_set_idc07f6ed5-a5f4-94ba-e053-2a95a90a24e7Package NDC81859-001-02UNIIV5VD430YW9

10)

drugcharacterization2medicinalproductFEXOFENADINEdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug4

activesubstance

activesubstancenameFEXOFENADINE\FEXOFENADINE HYDROCHLORIDE

openFDA Info on Medication

11)

drugcharacterization1medicinalproductCETIRIZINE HYDROCHLORIDE.drugauthorizationnumb019835drugdosageformUNSPECIFIEDdrugadministrationroute065drugindicationRASH PRURITICactiondrug1drugrecurreadministration3

activesubstance

activesubstancenameCETIRIZINE HYDROCHLORIDE

openFDA Info on Medication

Application Number ANDA090760, NDA022429, ANDA207235, ANDA078336, ANDA077946, ANDA090750, ANDA09025 ... Brand Name CETIRIZINE HYDROCHLORIDE (ALLERGY), ZYRTEC, CAREONE ALLERGY RELIEF, DG HEALTH AL ... Generic Name CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZI ... Manufacturers 7-Eleven, Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, ... product_ndc 10202-715, 50580-779, 41520-715, 55910-458, 0113-7002, 0781-1683, 63868-865, 553 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORAL, INTRAVENOUSActive IngredientsCETIRIZINE HYDROCHLORIDERXCUI 1014678, 1014675, 1020023, 1014676, 1014673, 1011482, 1014674, 1020022, 1014643, ... spl_id 429b73d2-5306-4792-9576-91ff3cc45f8e, cea20e63-c9ab-38c7-e053-2995a90adebe, ee2f ... spl_set_id 429b73d2-5306-4792-9576-91ff3cc45f8e, 605adf29-734f-451a-8ff3-74be7b5814a6, 833e ... Package NDC 10202-715-01, 50580-779-12, 50580-779-25, 50580-779-40, 50580-779-65, 41520-715- ... UNII64O047KTOA

12)

drugcharacterization2medicinalproductMETOPROLOL SUCCINATE.drugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug1

activesubstance

activesubstancenameMETOPROLOL SUCCINATE

openFDA Info on Medication

Application Number ANDA090617, ANDA203028, ANDA203894, ANDA203699, NDA210428, ANDA204161, ANDA21114 ... Brand NameMETOPROLOL SUCCINATE, KAPSPARGO, TOPROL XLGeneric NameMETOPROLOL SUCCINATE, METOPROLOL SUCCINATE ER TABLETSManufacturers BluePoint Laboratories, Pharmadax Inc., Nivagen Pharmaceuticals, Inc., Zydus Pha ... product_ndc 68001-121, 68001-122, 60050-001, 60050-002, 75834-290, 75834-291, 68382-564, 683 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETOPROLOL SUCCINATE, METOPROLOL TARTRATERXCUI 866427, 866436, 866412, 866419, 1999031, 1999033, 1999035, 1999037, 2047766, 204 ... spl_id 98f8056c-5885-e243-e053-2995a90a68d1, a2d8f185-a2c4-bc6f-e053-2995a90aeea9, da64 ... spl_set_id 7bacd1ea-5546-47a1-8cff-a30327cadec3, b292330e-c69c-4915-a984-e3a62a327796, da7a ... Package NDC 68001-121-00, 68001-121-03, 68001-122-00, 68001-122-03, 60050-001-01, 60050-001- ... UNIITH25PD4CCB, W5S57Y3A5L

13)

drugcharacterization2medicinalproductMONTELUKASTdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug1

activesubstance

activesubstancenameMONTELUKAST SODIUM

openFDA Info on Medication

Application Number ANDA204604, ANDA202843, ANDA203366, ANDA205107, ANDA091414, ANDA200889, ANDA2033 ... Brand NameMONTELUKAST SODIUM, MONTELUKASTGeneric NameMONTELUKASTManufacturers Amneal Pharmaceuticals LLC, XLCare Pharmaceuticals Inc., BluePoint Laboratories, ... product_ndc 65162-732, 72865-175, 68001-361, 31722-726, 65162-771, 65162-772, 0781-5554, 078 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMONTELUKAST SODIUMRXCUI200224, 242438, 311759, 351246spl_id 9f27baaf-c7bb-46f3-9410-6db624cbf785, bb0f591e-db58-2061-e053-2a95a90aaf29, d9db ... spl_set_id ccbbf0d6-efd9-4fdd-9e7b-e3d293062609, 82d65eea-c7c9-4e16-9176-46c43f00f0f6, 4c41 ... Package NDC 65162-732-03, 65162-732-09, 65162-732-11, 72865-175-30, 72865-175-90, 72865-175- ... UNIIU1O3J18SFL

14)

drugcharacterization1medicinalproductDIPHENHYDRAMINE HYDROCHLORIDE.drugauthorizationnumb999999drugdosageformUNSPECIFIEDdrugadministrationroute065drugindicationRASH PRURITICactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameDIPHENHYDRAMINE HYDROCHLORIDE

openFDA Info on Medication

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

15)

drugcharacterization2medicinalproductLATANOPROST.drugadministrationroute047drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug1

activesubstance

activesubstancenameLATANOPROST

openFDA Info on Medication

Application NumberANDA206519, ANDA201006, NDA206185, ANDA091449, NDA020597, ANDA202442, ANDA201786Brand NameLATANOPROST, XELPROS, XALATANGeneric NameLATANOPROSTManufacturers Aurobindo Pharma Limited, Bausch & Lomb Incorporated, Sun Pharmaceutical Industr ... product_ndc 65862-872, 24208-463, 47335-317, 61314-547, 59762-0333, 64980-516, 70069-421, 00 ... Product TypeHUMAN PRESCRIPTION DRUGRouteOPHTHALMIC, TOPICALActive IngredientsLATANOPROSTRXCUI314072, 2056743, 2056748, 542527spl_id 01c9b8fd-fe6d-4549-b40d-ebe2407d0993, 9bd23f33-8702-4041-955c-56096b198b14, 19c8 ... spl_set_id 19cdfef0-b770-4758-8f59-1769e4b6119c, 68aaacbe-98c5-450b-9bf4-4809d7ad2ca0, 34ad ... Package NDC 65862-872-25, 24208-463-25, 47335-317-90, 47335-317-98, 47335-317-92, 47335-317- ... NUIN0000175454, M0017805Established Pharmacologic ClassProstaglandin Analog [EPC]Chemical StructureProstaglandins [CS]UNII6Z5B6HVF6O

16)

drugcharacterization2medicinalproductMETHYLPREDNISOLONE.drugadministrationroute042actiondrug4

activesubstance

activesubstancenameMETHYLPREDNISOLONE

openFDA Info on Medication

Application Number NDA011153, ANDA209097, ANDA040189, ANDA040194, ANDA204072, ANDA212262, ANDA04018 ... Brand NameMEDROL, METHYLPREDNISOLONE, METHYLPREDNISOLONE SODIUM SUCCINATEGeneric NameMETHYLPREDNISOLONEManufacturers Pharmacia and Upjohn Company LLC, Lupin Pharmaceuticals, Inc., BluePoint Laborat ... product_ndc 0009-0020, 0009-0049, 0009-0056, 0009-0022, 0009-0073, 0009-0176, 68180-685, 681 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULAR, INTRAVENOUSActive IngredientsMETHYLPREDNISOLONE, METHYLPREDNISOLONE SODIUM SUCCINATERXCUI 197969, 197971, 197973, 207136, 207137, 207138, 207141, 259966, 260330, 328161, ... spl_id 8f9c2163-1d7f-4e6e-bbe5-d758de474744, c71a649a-a46d-4e69-81b8-f65e77a4c48b, 6135 ... spl_set_id 39d5270b-d957-4821-93d6-501b7b9f02d4, c5cbcea1-2200-4fc0-a49a-35edd9434873, a91f ... Package NDC 0009-0049-02, 0009-0056-02, 0009-0056-04, 0009-0022-01, 0009-0073-01, 0009-0176- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIX4W7ZR7023, LEC9GKY20K

17)

drugcharacterization2medicinalproductFLUTICASONEdrugadministrationroute045drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug1

activesubstance

activesubstancenameFLUTICASONE\FLUTICASONE PROPIONATE

openFDA Info on Medication

Application NumberANDA078492Brand NameFLUTICASONEGeneric NameFLUTICASONE PROPIONATEManufacturersMorton Grove Pharmaceuticals, Inc.product_ndc60432-264Product TypeHUMAN PRESCRIPTION DRUGRouteNASALActive IngredientsFLUTICASONE PROPIONATERXCUI1797907spl_ida9e7f8b6-a38a-4128-b1c8-8a008bd15842spl_set_id7c692ed5-959e-4c48-aeec-0799d8979693Package NDC60432-264-15UNIIO2GMZ0LF5W

18)

drugcharacterization2medicinalproductTIMOLOL.drugdosageformDROPSdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug1

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

19)

drugcharacterization2medicinalproductZOLPIDEMdrugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug1

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

20)

drugcharacterization2medicinalproductINSULINdrugadministrationroute042drugindicationBLOOD GLUCOSEactiondrug4

activesubstance

activesubstancenameINSULIN NOS

openFDA Info on Medication

Brand NameINSULIN 1556Generic NameINSULINManufacturersProfessional Complementary Health Formulasproduct_ndc63083-1556Product TypeHUMAN OTC DRUGRouteORALActive IngredientsINSULIN GLARGINEspl_id7511af53-86e7-46b5-a30e-a5d87817553cspl_set_id88170080-374d-456e-90bc-48e873878ce7Package NDC63083-1556-1NUIM0011417, N0000175453Chemical StructureInsulin [CS]Established Pharmacologic ClassInsulin Analog [EPC]UNII2ZM8CX04RZ