Active ingredient
Glycerol Phenylbutyrate
9 finished FDA listings contain Glycerol Phenylbutyrate as their only active ingredient.
At a glance
From the FDA NDC Directory
- Ingredient names as written by FDA
- GLYCEROL PHENYLBUTYRATE
- Dosage forms
- Liquid
- Routes
- Oral
- Manufacturers / labelers
- 9
- Strengths listed
- 1.1 g/ml
- Brand names in FDA listings
- Glycerol Phenylbutyrate, Ravicti
Official drug information
Source coverage for Glycerol Phenylbutyrate:
- FDA NDC Directory: linked
- RxNorm: linked
- Drugs@FDA: linked
- DailyMed: linked
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1368451
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
- NDA 203284
- Sponsor
- HORIZON THERAP US
- Original approval
- 2013-02-01
- Listings
- 2
- Application
- ANDA 205742
- Sponsor
- PH HEALTH
- Original approval
- 2021-12-02
- Listings
- 2
- Application
- ANDA 218738
- Sponsor
- TEVA PHARMS INC
- Original approval
- 2026-04-15
- Listings
- 1
- Application
- ANDA 219540
- Sponsor
- MSN
- Original approval
- 2026-04-15
- Listings
- 1
- Application
- ANDA 220313
- Sponsor
- AUROBINDO PHARMA
- Original approval
- 2026-04-15
- Listings
- 1
- Application
- ANDA 220568
- Sponsor
- NAVINTA LLC
- Original approval
- 2026-04-23
- Listings
- 2
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 203284 | HORIZON THERAP US | 2013-02-01 | 2 |
| ANDA 205742 | PH HEALTH | 2021-12-02 | 2 |
| ANDA 218738 | TEVA PHARMS INC | 2026-04-15 | 1 |
| ANDA 219540 | MSN | 2026-04-15 | 1 |
| ANDA 220313 | AUROBINDO PHARMA | 2026-04-15 | 1 |
| ANDA 220568 | NAVINTA LLC | 2026-04-23 | 2 |
Official labeling on DailyMed
- GLYCEROL PHENYLBUTYRATE (GLYCEROL PHENYLBUTYRATE ORAL) LIQUID [CAMBER PHARMACEUTICALS, INC.] · version 1 · 2026-08-25
- GLYCEROL PHENYLBUTYRATE LIQUID [NAVINTA LLC] · version 1 · 2026-07-15
- GLYCEROL PHENYLBUTYRATE LIQUID [ZYDUS PHARMACEUTICALS USA INC.] · version 1 · 2026-05-06
- GLYCEROL PHENYLBUTYRATE LIQUID [TEVA PHARMACEUTICALS, INC.] · version 1 · 2026-04-17
- GLYCEROL PHENYLBUTYRATE LIQUID [NOVADOZ PHARMACEUTICALS LLC] · version 1 · 2026-04-17
- GLYCEROL PHENYLBUTYRATE LIQUID [AUROBINDO PHARMA LIMITED] · version 1 · 2026-04-16
- RAVICTI (GLYCEROL PHENYLBUTYRATE) LIQUID [HORIZON THERAPEUTICS USA, INC.] · version 13 · 2025-11-20
- GLYCEROL PHENYLBUTYRATE (GLYCEROL PHENYLBUTYRATE ORAL) LIQUID [PAR HEALTH USA, LLC] · version 23 · 2025-11-17
- GLYCEROL PHENYLBUTYRATE LIQUID [LUPIN PHARMACEUTICALS, INC.] · version 1 · 2025-11-17
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.