FDA Orange Book
Is there a generic for Pheburane?
Pheburane contains sodium phenylbutyrate. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Pheburane (sodium phenylbutyrate).
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Pheburane products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| pellets, oral | 84GM/BOT | Marketed (Rx) | None | 0 | None |
NDA 216513, held by MEDUNIK CANADA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Pheburane NDC codes
Questions
Is there a generic for Pheburane?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Pheburane (sodium phenylbutyrate).
What is the generic name for Pheburane?
The active ingredient in Pheburane is sodium phenylbutyrate, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.