Data / Drug companies / Sodium phenylbutyrate
Sodium phenylbutyrate: 7 companies and 14 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Sodium phenylbutyrate is listed in the FDA National Drug Code Directory by 7 companies, with 14 products in commercial distribution. 4 of the products (28.6%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are kit; tablet; powder, and the newest product started marketing on July 10, 2026.
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- Companies listing it
- 7
- Products
- 14
- Generic (ANDA) products
- 4 (28.6%)
- Application numbers
- 7
- Routes
- Oral
- Brand names
- Olpruva, Pheburane, Buphenyl, Buphenyl
- openFDA record search
- api.fda.gov
Companies that list sodium phenylbutyrate
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Acer Therapeutics Inc. | 6 | kit | New drug applications (NDA) | December 22, 2022 |
| Horizon Therapeutics USA, Inc. | 2 | tablet; powder | New drug applications (NDA) | May 13, 1996 |
| Medunik | 2 | pellet; kit | New drug applications (NDA) | September 14, 2022 |
| Glenmark Pharmaceuticals Inc., USA | 1 | tablet | Generic drugs (ANDA) | November 1, 2022 |
| Navinta LLC | 1 | tablet | Generic drugs (ANDA) | July 10, 2026 |
| Par Health USA, LLC | 1 | powder | Generic drugs (ANDA) | August 31, 2016 |
| Zydus Pharmaceuticals USA Inc. | 1 | tablet | Generic drugs (ANDA) | March 23, 2026 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Kit | 7 | 50% |
| Tablet | 4 | 28.6% |
| Powder | 2 | 14.3% |
| Pellet | 1 | 7.1% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| New drug applications (NDA) | 10 | 71.4% |
| Generic drugs (ANDA) | 4 | 28.6% |
Pharmacologic classes
| Class | Products |
|---|---|
| Nitrogen Binding Agent | 7 |
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.