Active ingredient
Phenylbutyrate
8 finished FDA listings contain Phenylbutyrate as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- SODIUM PHENYLBUTYRATE
- Dosage forms
- Pellet, Powder, Tablet
- Routes
- Oral
- Manufacturers / labelers
- 6
- Strengths listed
- .94 g/g · 483 mg/g · 500 mg/1
- Brand names in FDA listings
- Buphenyl, Pheburane, Sodium Phenylbutyrate
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 81647
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 020573 | HORIZON THERAP US | 1996-04-30 | 1 |
| NDA 020572 | HORIZON THERAP US | 1996-05-13 | 1 |
| ANDA 204395 | PH HEALTH | 2016-04-15 | 1 |
| ANDA 203918 | PH HEALTH | 2016-06-15 | 1 |
| NDA 216513 | MEDUNIK | 2022-06-17 | 1 |
| ANDA 216462 | GLENMARK PHARMS LTD | 2022-11-01 | 1 |
| ANDA 220418 | NAVINTA LLC | 2026-02-17 | 2 |
Official labeling on DailyMed
- PHEBURANE (SODIUM PHENYLBUTYRATE) PELLET PHEBURANE (SODIUM PHENYLBUTYRATE) KIT [MEDUNIK USA] · version 7 · 2026-07-23
- SODIUM PHENYLBUTYRATE TABLET [NAVINTA LLC] · version 1 · 2026-07-15
- SODIUM PHENYLBUTYRATE (SODIUM PHENYLBUTYRATE TABLETS, 500 MG) TABLET [PAR HEALTH USA, LLC] · version 10 · 2026-05-14
- SODIUM PHENYLBUTYRATE TABLET [ZYDUS PHARMACEUTICALS USA INC.] · version 2 · 2026-04-30
- SODIUM PHENYLBUTYRATE POWDER [PAR HEALTH USA, LLC] · version 10 · 2026-04-28
- SODIUM PHENYLBUTYRATE TABLET [GLENMARK PHARMACEUTICALS INC., USA] · version 3 · 2026-01-29
- BUPHENYL (SODIUM PHENYLBUTYRATE) TABLET BUPHENYL (SODIUM PHENYLBUTYRATE) POWDER [HORIZON THERAPEUTICS USA, INC.] · version 9 · 2024-11-14
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.