Buphenyl is a brand name of Sodium phenylbutyrate, a prescription medicine. The FDA NDC Directory lists 2 Buphenyl products in 2 strengths and forms.

Horizon Therap US holds the FDA application for Buphenyl (NDA020573, approved April 30, 1996).

Is there a generic or store brand of Buphenyl?

Yes. The FDA NDC Directory lists 5 other products with the same active ingredients, strength and form as a Buphenyl product, 5 of them generic. Ask your pharmacist whether one is right for you.

Buphenyl (Sodium phenylbutyrate): maker, FDA approval and generic versions

Official data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the NDC Directory, Drugs@FDA, the official labels and recall reports; pharmacy costs come from the Centers for Medicare & Medicaid Services (CMS). Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or switch any medicine, including a switch between a brand and a generic.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Quick answers

What is Buphenyl?: Buphenyl is a brand name of Sodium phenylbutyrate, a prescription medicine. The FDA NDC Directory lists 2 Buphenyl products in 2 strengths and forms.
Who makes Buphenyl?: Horizon Therap US holds the FDA application for Buphenyl (NDA020573, approved April 30, 1996).
Is there a generic or store brand of Buphenyl?: Yes. The FDA NDC Directory lists 5 other products with the same active ingredients, strength and form as a Buphenyl product, 5 of them generic. Ask your pharmacist whether one is right for you.
Has Buphenyl been recalled?: No recall linked to Buphenyl products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Buphenyl is

Each Buphenyl 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.

Sodium phenylbutyrate · prescription medicine

Strength and form	Product names	Same medicine, other names	Label
sodium phenylbutyrate 500 mg tablet (oral)	Buphenyl	4 products, 4 companies	DailyMed
sodium phenylbutyrate 94% powder (oral)	Buphenyl	1 product, 1 company	DailyMed

Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Sodium phenylbutyrate →

FDA approval

NDA: New Drug Application: how a new (usually brand-name) medicine is approved.

FDA applications of Buphenyl products (Drugs@FDA)
Application	Holder	First approved	Products
NDA020573	Horizon Therap US	April 30, 1996	1
NDA020572	Horizon Therap US	May 13, 1996	1

Companies that list Buphenyl

The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Buphenyl products.

Horizon Therapeutics USA, Inc.2 products

Recalls

No recall linked to Buphenyl 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.

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Buphenyl