Data / Drug companies / Fluorouracil
Fluorouracil: 21 companies and 50 products in the FDA NDC directory
Fluorouracil is listed in the FDA National Drug Code Directory by 21 companies, with 50 products in commercial distribution. 45 of the products (90.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are injection, solution; cream; solution, and the newest product started marketing on September 7, 2026.
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- Companies listing it
- 21
- Products
- 50
- Generic (ANDA) products
- 45 (90.0%)
- Application numbers
- 22
- Routes
- Intravenous, Topical
- Brand names
- Favlyxa, Tolak, Efudex
- openFDA record search
- api.fda.gov
Companies that list fluorouracil
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Fresenius Kabi USA, LLC | 6 | injection, solution | Generic drugs (ANDA) | January 2, 2017 |
| BluePoint Laboratories | 4 | injection, solution | Generic drugs (ANDA) | January 31, 2025 |
| Eugia US LLC | 4 | injection, solution | Generic drugs (ANDA) | April 8, 2022 |
| Gland Pharma Limited | 4 | injection, solution | Generic drugs (ANDA) | January 5, 2018 |
| Heritage Pharmaceuticals Inc. D/B/A Avet Pharmaceuticals Inc. | 4 | injection, solution | Generic drugs (ANDA) | September 7, 2026 |
| Xiromed, LLC | 4 | injection, solution | Generic drugs (ANDA) | August 13, 2021 |
| Accord Healthcare Inc. | 3 | injection, solution; cream | Generic drugs (ANDA) | November 11, 2021 |
| Sun Pharmaceutical Industries, Inc. | 3 | solution; cream | Generic drugs (ANDA) | March 5, 2010 |
| Alembic Pharmaceuticals Inc. | 2 | injection, solution | Generic drugs (ANDA) | October 18, 2023 |
| Alembic Pharmaceuticals Limited | 2 | injection, solution | Generic drugs (ANDA) | October 18, 2023 |
| Avyxa Pharma, LLC | 2 | injection, solution | New drug applications (NDA) | July 15, 2026 |
| Encube Ethicals, Inc. | 2 | solution; cream | Generic drugs (ANDA) | February 14, 2025 |
| Meitheal Pharmaceuticals Inc. | 2 | injection, solution | Generic drugs (ANDA) | February 6, 2025 |
| Bausch Health US LLC | 1 | cream | New drug applications (NDA) | July 29, 1970 |
| Dr. Reddy's Laboratories Inc. | 1 | cream | Generic drugs (ANDA) | April 15, 2024 |
| Hill Dermaceuticals, Inc. | 1 | cream | New drug applications (NDA) | September 18, 2015 |
| Mayne Pharma Inc. | 1 | cream | Generic drugs (ANDA) | December 3, 2019 |
| Mylan Pharmaceuticals Inc. | 1 | cream | Authorized generics (NDA) | September 19, 2013 |
| NorthStar Rx LLC | 1 | cream | Generic drugs (ANDA) | March 5, 2010 |
| ProPharma Distribution | 1 | injection, solution | Generic drugs (ANDA) | January 2, 2017 |
| Sagent Pharmaceuticals | 1 | injection, solution | Generic drugs (ANDA) | September 15, 2016 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Injection, solution | 38 | 76% |
| Cream | 9 | 18% |
| Solution | 3 | 6% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 45 | 90% |
| New drug applications (NDA) | 4 | 8% |
| Authorized generics (NDA) | 1 | 2% |
Pharmacologic classes
| Class | Products |
|---|---|
| Nucleoside Metabolic Inhibitor | 50 |
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.