Prescription drug · NDA
Jelmyto (Mitomycin) NDC 72493-103
Kit · UroGen Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72493-103-03 | 7249301030372493010303 | 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)Marketed from May 1, 2020 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Jelmyto
- Generic name (nonproprietary)
- mitomycin
- Dosage form
- Kit
- Labeler
- UroGen Pharma, Inc.NDC labeler code 72493
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 211728
- Marketing start
- Listing expires
- Identifiers
- Product ID 72493-103_e545c060-c1c8-43af-b77e-7e951af59e1dSPL ID e545c060-c1c8-43af-b77e-7e951af59e1dSPL set ID 3d3d5053-5427-4a68-a40b-edb60699521eRxCUI 2375818, 2375823
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N472493010303followed by a unit qualifier and the quantityPackage 72493-0103-03. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
JELMYTO ® is indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC). JELMYTO is an alkylating drug indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC). ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 72493-103
- What is NDC 72493-103?
- 72493-103 is the product NDC for Jelmyto (mitomycin) kit, listed with the FDA by UroGen Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Jelmyto (Mitomycin).
- Who is the labeler?
- UroGen Pharma, Inc., NDC labeler code 72493. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Jelmyto?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.