Data / Drug companies / Sodium phenylacetate and sodium benzoate
Sodium phenylacetate and sodium benzoate: 7 companies and 10 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Sodium phenylacetate and sodium benzoate is listed in the FDA National Drug Code Directory by 7 companies, with 10 products in commercial distribution. 8 of the products (80.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are injection, solution, concentrate; injection, and the newest product started marketing on December 6, 2025.
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- Companies listing it
- 7
- Products
- 10
- Generic (ANDA) products
- 8 (80.0%)
- Application numbers
- 5
- Routes
- Intravenous
- openFDA record search
- api.fda.gov
Companies that list sodium phenylacetate and sodium benzoate
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Maia Pharmaceuticals, Inc. | 2 | injection, solution, concentrate; injection | Generic drugs (ANDA) | July 1, 2021 |
| Navinta LLC | 2 | injection, solution, concentrate | Generic drugs (ANDA) | December 6, 2025 |
| Omnivium Pharmaceuticals LLC. | 2 | injection, solution, concentrate | Generic drugs (ANDA) | May 15, 2025 |
| Ailex Pharmaceuticals, LLC | 1 | injection, solution, concentrate | Generic drugs (ANDA) | February 24, 2016 |
| Fosun Pharma USA Inc. | 1 | injection | New drug applications (NDA) | November 14, 2021 |
| Zydus Pharmaceuticals USA Inc. | 1 | injection, solution, concentrate | Generic drugs (ANDA) | February 8, 2021 |
| Zydus Pharmaceuticals USA Inc. | 1 | injection, solution, concentrate | Generic drugs (ANDA) | September 19, 2023 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Injection, solution, concentrate | 8 | 80% |
| Injection | 2 | 20% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 8 | 80% |
| New drug applications (NDA) | 2 | 20% |
Pharmacologic classes
| Class | Products |
|---|---|
| Nitrogen Binding Agent | 10 |
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.