Data / Drug companies / Leflunomide
Leflunomide: 19 companies and 40 products in the FDA NDC directory
Leflunomide is listed in the FDA National Drug Code Directory by 19 companies, with 40 products in commercial distribution. 37 of the products (92.5%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated; tablet, and the newest product started marketing on January 3, 2022.
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- Companies listing it
- 19
- Products
- 40
- Generic (ANDA) products
- 37 (92.5%)
- Application numbers
- 9
- Routes
- Oral
- Brand names
- Arava
- openFDA record search
- api.fda.gov
Companies that list leflunomide
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Bryant Ranch Prepack | 4 | tablet, film coated; tablet | Generic drugs (ANDA) | March 29, 2021 |
| Sanofi-Aventis U.S. LLC | 3 | tablet, film coated | New drug applications (NDA) | September 10, 1998 |
| A-S Medication Solutions | 2 | tablet, film coated | Generic drugs (ANDA) | March 29, 2021 |
| Alembic Pharmaceuticals Inc. | 2 | tablet | Generic drugs (ANDA) | December 1, 2016 |
| Alembic Pharmaceuticals Limited | 2 | tablet | Generic drugs (ANDA) | December 1, 2016 |
| Apotex Corp. | 2 | tablet | Generic drugs (ANDA) | September 13, 2005 |
| Aurobindo Pharma Limited | 2 | tablet, film coated | Generic drugs (ANDA) | March 29, 2021 |
| AvKARE | 2 | tablet | Generic drugs (ANDA) | June 13, 2019 |
| AvPAK | 2 | tablet | Generic drugs (ANDA) | September 17, 2020 |
| Bryant Ranch Prepack | 2 | tablet | Generic drugs (ANDA) | October 29, 2009 |
| Burel Pharmaceuticals, LLC | 2 | tablet, film coated | Generic drugs (ANDA) | January 3, 2022 |
| Chartwell RX, LLC | 2 | tablet | Generic drugs (ANDA) | October 29, 2009 |
| Heritage Pharmaceuticals Inc. D/B/A Avet Pharmaceuticals Inc. | 2 | tablet | Generic drugs (ANDA) | October 29, 2009 |
| KVK-Tech, Inc. | 2 | tablet | Generic drugs (ANDA) | July 23, 2020 |
| Lupin Pharmaceuticals, Inc. | 2 | tablet, film coated | Generic drugs (ANDA) | August 31, 2020 |
| NuCare Pharmaceuticals,Inc. | 2 | tablet, film coated | Generic drugs (ANDA) | August 31, 2020 |
| Zydus Lifesciences Limited | 2 | tablet, film coated | Generic drugs (ANDA) | April 26, 2019 |
| Zydus Pharmaceuticals USA Inc. | 2 | tablet, film coated | Generic drugs (ANDA) | April 26, 2019 |
| Bryant Ranch Prepack | 1 | tablet, film coated | Generic drugs (ANDA) | March 29, 2021 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated | 20 | 50% |
| Tablet | 20 | 50% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 37 | 92.5% |
| New drug applications (NDA) | 3 | 7.5% |
Pharmacologic classes
| Class | Products |
|---|---|
| Antirheumatic Agent | 40 |
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.