Quick answers
- What is Sodium phenylbutyrate used for?
- The FDA-approved label (Buphenyl, Horizon Therapeutics USA, Inc., October 30, 2024) says: “BUPHENYL is indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamoyl phosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). It is indicated in all patients with neonatal-onset deficiency (complete enzymatic deficiency, presenting within the first 28 days of life). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Sodium phenylbutyrate have a boxed warning?
- No. None of the 7 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Sodium phenylbutyrate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Sodium phenylbutyrate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Sodium phenylbutyrate?
- 6 companies list prescription products of Sodium phenylbutyrate in the FDA NDC Directory, including Par Health USA, LLC, Horizon Therapeutics USA, Inc. and Medunik USA.
What Sodium phenylbutyrate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
BUPHENYL is indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamoyl phosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). It is indicated in all patients with neonatal-onset deficiency (complete enzymatic deficiency, presenting within the first 28 days of life). …
— FDA label: Buphenyl, Horizon Therapeutics USA, Inc., effective October 30, 2024. Read the full label on DailyMed →
The FDA has 7 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 7 FDA labels for this medicine have a boxed warning.
Forms and how it is given
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Par Health USA, LLC2 products
- Horizon Therapeutics USA, Inc.2 products
- Medunik USA1 product
- Glenmark Pharmaceuticals Inc., USA1 product
- Navinta LLC1 product
- Zydus Pharmaceuticals USA Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020572 BUPHENYL | Horizon Therap Us | May 13, 1996 | 6, latest July 29, 2022 2022: Labeling · 2015: Manufacturing (CMC) · 2013: Manufacturing (CMC) |
| NDA020573 BUPHENYL | Horizon Therap Us | April 30, 1996 | 5, latest July 29, 2022 2022: Labeling · 2013: Manufacturing (CMC) · 2009: Labeling |
| NDA216513 PHEBURANE | Medunik | June 17, 2022 | 1, latest July 16, 2026 2026: Labeling |
Generic approvals (4)
- ANDA204395Ph Health · April 15, 2016
- ANDA203918Ph Health · June 15, 2016
- ANDA216462Glenmark Pharms Ltd · November 1, 2022
- ANDA220418Navinta LLC · February 17, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Buphenyl, Horizon Therapeutics USA, Inc., effective October 30, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- 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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →