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 | 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 | 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#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Sterile Water | WATER | Fresenius Kabi USA, LLC | b45e9f1d-9c48-4b46-8541-d846b89540df | 2022-10-26 | Warnings, Adverse reactions | 059QF0KO0R |
| Eye wash | PURIFIED WATER | McKesson | bd089fde-24ba-4de5-e053-2995a90a39bb | 2022-10-18 | Warnings | 059QF0KO0R |
| Bach Original Flower Remedies Rock Water | WATER | Nelson Bach USA Limited | ea242559-1618-3354-e053-2a95a90a1a95 | 2022-10-03 | Warnings | 059QF0KO0R |
| Mitomycin | MITOMYCIN | Hikma Pharmaceuticals USA Inc. | fde1e4e9-fc67-4e84-aa31-0cf0e73e19a8 | 2022-09-27 | Boxed warning, Warnings, Adverse reactions | 50SG953SK6 |
| Sterile Water | WATER | Medical Purchasing Solutions, LLC | e90b47e3-9636-b9ee-e053-2a95a90ad48c | 2022-09-19 | Warnings, Adverse reactions | 059QF0KO0R |
| MITOMYCIN | MITOMYCIN | Meitheal Pharmaceuticals Inc. | 9dd0e3f2-0938-4c57-8d09-040b5405b44f | 2022-09-08 | Boxed warning, Warnings, Adverse reactions | 50SG953SK6 |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | f42ac50f-0ec5-4713-a4c8-99d972d90bed | 2022-06-22 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | e71c6c83-d518-496c-b2ab-efd5987e4783 | 2022-06-09 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | American Regent, Inc. | 78b35864-4bbc-4759-a5c1-7e4f25e22932 | 2022-01-31 | Boxed warning | 059QF0KO0R |
| d44ffd1f-d257-4d1a-e053-2a95a90a024c | d44ffaf0-701c-4b84-e053-2a95a90a35b9 | 2021-12-29 | Warnings, Adverse reactions | d44ffd1f-d257-4d1a-e053-2a95a90a024c d44ffaf0-701c-4b84-e053-2a95a90a35b9 | ||
| Sterile Diluent for Treprostinil | WATER | Dr.Reddy's Laboratories Inc., | 33050ee2-519b-1f0b-d4df-9e14dd329c57 | 2021-12-23 | Warnings, Adverse reactions | 059QF0KO0R |
| MITOMYCIN | MITOMYCIN | Gland Pharma Limited | 650d3024-b9a9-4018-8115-0951acfe3145 | 2021-10-22 | Boxed warning, Warnings, Adverse reactions | 50SG953SK6 |
| Sterile Water | STERILE WATER | B. Braun Medical Inc. | d99f9133-e4d0-4dee-b611-dbc3f918b547 | 2021-08-09 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | B. Braun Medical Inc. | 8924e52e-8622-4ed6-a061-1908183e0a18 | 2021-08-06 | Warnings, Adverse reactions | 059QF0KO0R |
| MITOMYCIN | MITOMYCIN | Meitheal Pharmaceuticals Inc. | eae9a8bc-84ec-4303-bc43-f656a5ce0fb7 | 2021-07-29 | Boxed warning, Warnings, Adverse reactions | 50SG953SK6 |
| Eyewash | EYEWASH | Global Equipment Company | c4f78121-4668-2e0c-e053-2995a90ab6c6 | 2021-06-17 | Warnings | 059QF0KO0R |
| Sterile Water | WATER | Asclemed USA, Inc. | 45c38269-883c-4198-a9d5-03810a4420ec | 2021-01-14 | Warnings, Adverse reactions | 059QF0KO0R |
| Bach Original Flower Remedies | WATER | Nelson Bach USA Limited | 09c76050-42c5-4403-865c-a1f6f668d9c0 | 2020-06-15 | Warnings | 059QF0KO0R |
| Sterile Water | WATER | Baxter Healthcare Company | 8bcf5572-49e1-4302-9522-56f57904cb4a | 2019-12-29 | Warnings, Adverse reactions | 059QF0KO0R |
| Dynamic Eyewash with Eyecup | WATER | Dynamic Safety International | 7d3af0f4-0e1f-9ea5-e053-2991aa0af7a2 | 2018-12-17 | Warnings | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.