JELMYTO
- Product NDC
- 72493-103
- 11-digit product format
- 724930103
- Labeler code
- 72493
- Product ID
- 72493-103_e545c060-c1c8-43af-b77e-7e951af59e1d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mitomycin
- Dosage form
- KIT
- Labeler
- UroGen Pharma, Inc.
- Application
- NDA211728
- Marketing category
- NDA
- Marketing start
- 2020-05-01
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- JELMYTO
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 2375818, 2375823 |
DailyMed Product Concepts#
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 |
| 72493-103-03 | JELMYTO | 1 in 1 CARTON | KIT | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72493-103 | JELMYTO (MITOMYCIN) KIT [UROGEN PHARMA, INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241018_3d3d5053-5427-4a68-a40b-edb60699521e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 72493-101-40 | 72493010140 | 1 in 1 VIAL, SINGLE-DOSE | | | | | | Historical |
| 72493-103-03 | 72493010303 | 1 KIT in 1 CARTON (72493-103-03) * 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72493-101-40) * 20 mL in 1 VIAL, SINGLE-DOSE (72493-102-20) | 1 kit | 2020-05-01 | 0000-00-00 | No | No | Current |