Data / Drug companies / Mitomycin
Mitomycin: 14 companies and 36 products in the FDA NDC directory
Mitomycin is listed in the FDA National Drug Code Directory by 14 companies, with 36 products in commercial distribution. 33 of the products (91.7%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are injection, powder, lyophilized, for solution; kit, and the newest product started marketing on July 1, 2025.
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- Companies listing it
- 14
- Products
- 36
- Generic (ANDA) products
- 33 (91.7%)
- Application numbers
- 12
- Routes
- Intravenous
- Brand names
- Mutamycin, Jelmyto, Zusduri, Mitosol
- openFDA record search
- api.fda.gov
Companies that list mitomycin
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Archis Pharma LLC | 4 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | April 25, 2022 |
| Hikma Pharmaceuticals USA Inc. | 4 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | October 1, 2022 |
| Accord Healthcare Inc. | 3 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | March 11, 2011 |
| BluePoint Laboratories | 3 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | July 11, 2024 |
| Eugia US LLC | 3 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | October 30, 2023 |
| Fresenius Kabi USA, LLC | 3 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | January 15, 2023 |
| Gland Pharma Limited | 3 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | November 22, 2022 |
| Meitheal Pharmaceuticals Inc. | 3 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | September 8, 2022 |
| Sagent Pharmaceuticals | 3 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | June 15, 2023 |
| Accord BioPharma Inc. | 2 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | July 25, 2017 |
| UroGen Pharma, Inc. | 2 | kit | New drug applications (NDA) | July 1, 2025 |
| Bryant Ranch Prepack | 1 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | March 11, 2022 |
| Bryant Ranch Prepack | 1 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | March 11, 2022 |
| Mobius Therapeutics LLC | 1 | kit | New drug applications (NDA) | February 8, 2012 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Injection, powder, lyophilized, for solution | 33 | 91.7% |
| Kit | 3 | 8.3% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 33 | 91.7% |
| New drug applications (NDA) | 3 | 8.3% |
Pharmacologic classes
| Class | Products |
|---|---|
| Alkylating Drug | 33 |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.