FDA.reportPublic FDA data

NDC 72493-101 - JELMYTO

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
72493-101
Package NDCs from labels
72493-101-40
Manufacturer
UroGen Pharma, Inc. | UroGen Pharma, Ltd.
Effective date
2025-07-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
JELMYTO - UroGen Pharma, Inc. | UroGen Pharma, Ltd.UroGen Pharma, Inc. | UroGen Pharma, Ltd.2025-07-09HUMAN PRESCRIPTION DRUG LABEL
JELMYTO - CENEXI - BLA | Cenexi - Laboratoires Thissen SaCENEXI - BLA | Cenexi - Laboratoires Thissen Sa2021-12-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72493-101-40JELMYTO1 in 1 VIAL, SINGLE-DOSEPOWDER, FOR SOLUTION240 mg6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72493-101JELMYTO (MITOMYCIN) KIT [UROGEN PHARMA, INC.]5Unmatched20241018_3d3d5053-5427-4a68-a40b-edb60699521e.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 10 of 12 · 224 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anubis BarcelonaFERULIC ACID, VITAMIN C, DMAEANUBIS COSMETICS SLeaf0770c-795d-0232-e053-2a95a90ae0b52023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Regul OIlPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ARCTIUM MAJUS ROOT EXTRACTANUBIS COSMETICS SLeb905bd0-c600-b8b2-e053-2995a90ad2592023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Regul OilPROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACTANUBIS COSMETICS SLeb7c418b-8bee-26a3-e053-2a95a90a4e962023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Vital LineHYDROLYZED COLLAGENANUBIS COSMETICS SLf564bbf0-3b5c-4a81-e053-2a95a90a7ea62023-08-29WarningsExact identifier
unii: 059QF0KO0R
MannitolMANNITOLB. Braun Medical Inc.d12cc802-b538-4065-a264-f474ff3b30432023-08-15Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MitomycinMITOMYCINArchis Pharma LLC2ecd0f9c-0980-4ac5-bd1b-0a0aee799b6f2023-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 50SG953SK6
MitomycinMITOMYCINSagent Pharmaceuticals10c41a58-c305-4240-80d2-caa0704126482023-05-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 50SG953SK6
MitomycinMITOMYCINSagent Pharmaceuticals0171a1c8-c474-4ec1-a11d-6b93a21ca4602023-05-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 50SG953SK6
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MannitolMANNITOLFresenius Kabi USA, LLCc395e13d-6ea1-4104-8b37-669cfb982f042023-03-16Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
NOVOLOGINSULIN ASPARTNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MITOMYCINMITOMYCINFresenius Kabi USA, LLCbc937e3d-7167-49a5-b6b1-004b0f89d8c42023-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 50SG953SK6
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R
MITOMYCINMITOMYCINFresenius Kabi USA, LLC6a4fbc96-e35d-41c2-91fc-4b48220bdba22023-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 50SG953SK6
MITOMYCINMITOMYCINGland Pharma Limited2528999b-9f09-4e64-89fc-1e3d69c2d0b62022-11-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 50SG953SK6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.