Pheburane is a brand name of Sodium phenylbutyrate, a prescription medicine. The FDA NDC Directory lists 1 Pheburane product in 1 strength and form.

Medunik holds the FDA application for Pheburane (NDA216513, approved June 17, 2022).

Is there a generic or store brand of Pheburane?

Other products of Sodium phenylbutyrate are listed with the FDA, but none in exactly the same strength and form as a Pheburane product.

Pheburane (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 Pheburane?: Pheburane is a brand name of Sodium phenylbutyrate, a prescription medicine. The FDA NDC Directory lists 1 Pheburane product in 1 strength and form.
Who makes Pheburane?: Medunik holds the FDA application for Pheburane (NDA216513, approved June 17, 2022).
Is there a generic or store brand of Pheburane?: Other products of Sodium phenylbutyrate are listed with the FDA, but none in exactly the same strength and form as a Pheburane product.
Has Pheburane been recalled?: No recall linked to Pheburane products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Pheburane is

Each Pheburane 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 48.3% pellet (oral)	Pheburane	None listed	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 Pheburane products (Drugs@FDA)
Application	Holder	First approved	Products
NDA216513	Medunik	June 17, 2022	1

Companies that list Pheburane

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

Medunik USA1 product

Recalls

No recall linked to Pheburane 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.

Report an error → · Information for medicine makers

Pheburane