Drug
Who makes sodium phenylacetate and sodium benzoate?
6 companies list sodium phenylacetate and sodium benzoate as a human prescription drug. Forms: injection; injection, solution, concentrate. Routes: intravenous.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing sodium phenylacetate and sodium benzoate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Navinta LLCUnited States | injection, solution, concentrate | ANDAANDA205880, ANDA217526 | 2 | 1 |
| Zydus Pharmaceuticals USA Inc.India | injection, solution, concentrate | ANDAANDA205880, ANDA217526 | 2 | 1 |
| MAIA Pharmaceuticals, Inc. | injection; injection, solution, concentrate | ANDA, NDAANDA208521, NDA215025 | 2 | 0 |
| Omnivium Pharmaceuticals LLC | injection, solution, concentrate | ANDAANDA207096 | 2 | 0 |
| Ailex Pharmaceuticals, LLC | injection, solution, concentrate | ANDAANDA207096 | 1 | 0 |
| Fosun Pharma USA Inc. | injection | NDANDA215025 | 1 | 0 |
Enquiry
Common questions
- Who makes sodium phenylacetate and sodium benzoate?
- 6 companies list sodium phenylacetate and sodium benzoate as a human prescription drug in the openFDA NDC Directory, led by Navinta LLC, Zydus Pharmaceuticals USA Inc., MAIA Pharmaceuticals, Inc., Omnivium Pharmaceuticals LLC, Ailex Pharmaceuticals, LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic sodium phenylacetate and sodium benzoate?
- 5 companies list sodium phenylacetate and sodium benzoate under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.