Quick answers
- What is Ravicti?
- Ravicti is a brand name of Glycerol phenylbutyrate, a prescription medicine. The FDA NDC Directory lists 1 Ravicti product in 1 strength and form.
- Who makes Ravicti?
- Horizon Therap US holds the FDA application for Ravicti (NDA203284, approved February 1, 2013).
- Is there a generic or store brand of Ravicti?
- Yes. The FDA NDC Directory lists 9 other products with the same active ingredients, strength and form as a Ravicti product, 8 of them generic. Ask your pharmacist whether one is right for you.
- Has Ravicti been recalled?
- No recall linked to Ravicti products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Ravicti is
Each Ravicti product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Glycerol phenylbutyrate · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| glycerol phenylbutyrate 1.1 g/mL liquid (oral) | Ravicti | 9 products, 9 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Glycerol phenylbutyrate →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA203284 | Horizon Therap US | February 1, 2013 | 1 |
Companies that list Ravicti
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Ravicti products.
- Horizon Therapeutics USA, Inc.1 product
Recalls
No recall linked to Ravicti products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.