Data / Drug companies / Zileuton
Zileuton: 6 companies and 6 products in the FDA NDC directory
Zileuton is listed in the FDA National Drug Code Directory by 6 companies, with 6 products in commercial distribution. 5 of the products (83.3%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, multilayer, extended release; tablet, film coated, extended release; tablet, and the newest product started marketing on May 1, 2024.
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- Companies listing it
- 6
- Products
- 6
- Generic (ANDA) products
- 5 (83.3%)
- Application numbers
- 4
- Routes
- Oral
- Brand names
- Zyflo
- openFDA record search
- api.fda.gov
Companies that list zileuton
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Camber Pharmaceuticals, Inc. | 1 | tablet, film coated, extended release | Generic drugs (ANDA) | October 11, 2022 |
| Chiesi USA, Inc. | 1 | tablet | New drug applications (NDA) | December 6, 1996 |
| Golden State Medical Supply, Inc. | 1 | tablet, multilayer, extended release | Generic drugs (ANDA) | December 16, 2019 |
| NorthStar RxLLC | 1 | tablet, film coated, extended release | Generic drugs (ANDA) | May 1, 2024 |
| Rising Pharma Holdings, Inc. | 1 | tablet, extended release | Generic drugs (ANDA) | March 21, 2017 |
| Strides Pharma Science Limited | 1 | tablet, multilayer, extended release | Generic drugs (ANDA) | October 15, 2022 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, multilayer, extended release | 2 | 33.3% |
| Tablet, film coated, extended release | 2 | 33.3% |
| Tablet | 1 | 16.7% |
| Tablet, extended release | 1 | 16.7% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 5 | 83.3% |
| New drug applications (NDA) | 1 | 16.7% |
Pharmacologic classes
| Class | Products |
|---|---|
| 5-Lipoxygenase Inhibitor | 6 |
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.