Drug
Who makes sodium phenylbutyrate?
7 companies list sodium phenylbutyrate as a human prescription drug, including under the names Buphenyl, OLPRUVA, PHEBURANE. Forms: kit; pellet; powder; tablet. Routes: oral.
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 phenylbutyrate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Acer Therapeutics Inc. | kit | NDANDA214860 | 6 | 0 |
| Horizon Pharmaceuticals , Inc.United States | powder; tablet | NDANDA020572, NDA020573 | 2 | 1 |
| Medunik USA | kit; pellet | NDANDA216513 | 2 | 0 |
| Glenmark Pharmaceuticals Inc., USAIndia | tablet | ANDAANDA216462 | 1 | 9 |
| Par Health USA, LLCIndia | powder | ANDAANDA203918 | 1 | 5 |
| Navinta LLCUnited States | tablet | ANDAANDA220418 | 1 | 1 |
| Zydus Pharmaceuticals USA Inc.India | tablet | ANDAANDA220418 | 1 | 1 |
Bulk ingredient listings
- APOTHECON PHARMACEUTICALS PRIVATE LIMITEDIndia · 1 NDC
- AX Pharmaceutical CorpCanada · 1 NDC
- CU Chemie Uetikon GmbHGermany · 1 NDC
- Darmerica, LLCUnited States · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- PCASFrance · 1 NDC
- Par Active Technologies Private Limited · 1 NDC
- STHREE CHEMICALS PRIVATE LIMITEDIndia · 1 NDC
- Sri Krishna Pharmaceuticals Ltd. Unit I · 1 NDC
Orange Book patents
3 unexpired patents list sodium phenylbutyrate as the active ingredient, expiring between Oct 2036 and Oct 2036. Application holder: ACER THERAPEUTICS INC.
Enquiry
Common questions
- Who makes sodium phenylbutyrate?
- 7 companies list sodium phenylbutyrate as a human prescription drug in the openFDA NDC Directory, led by Acer Therapeutics Inc., Horizon Pharmaceuticals , Inc., Medunik USA, Glenmark Pharmaceuticals Inc., USA, Par Health USA, 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 Buphenyl?
- 4 companies list sodium phenylbutyrate under an abbreviated new drug application (ANDA), the application type used for generics, and 3 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies sodium phenylbutyrate active ingredient?
- 9 companies list sodium phenylbutyrate as a bulk ingredient, including APOTHECON PHARMACEUTICALS PRIVATE LIMITED, AX Pharmaceutical Corp, CU Chemie Uetikon GmbH, Darmerica, LLC.