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
Label	Manufacturer	Effective date	Type
JELMYTO - UroGen Pharma, Inc. \| UroGen Pharma, Ltd.	UroGen Pharma, Inc. \| UroGen Pharma, Ltd.	2025-07-09	HUMAN PRESCRIPTION DRUG LABEL
JELMYTO - CENEXI - BLA \| Cenexi - Laboratoires Thissen Sa	CENEXI - BLA \| Cenexi - Laboratoires Thissen Sa	2021-12-29	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72493-101-40	JELMYTO	1 in 1 VIAL, SINGLE-DOSE	POWDER, FOR SOLUTION	2	40 mg	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72493-101	JELMYTO (MITOMYCIN) KIT [UROGEN PHARMA, INC.]	5	Unmatched	20241018_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 12 of 12 · 224 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bio Rock Water	ROCK WATER	BioActive Nutritional, Inc.	178bd16d-0d4f-49d8-866b-8ab3a3c6889d	2018-07-30	Warnings	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Baxter Healthcare Corporation	ef3e79c5-3f58-4b36-a296-64b7d9a651c1	2017-10-17	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Eye Wash	WATER	CVS Pharmacy	049cee29-7ec2-4d5b-8308-f522acde43a7	2017-03-29	Warnings	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Baxter Healthcare Company	210dc9ab-d6ca-4552-ac19-1be17792d290	2016-05-31	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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