FDA Orange Book
Generic for Buphenyl
Buphenyl 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
Yes. The generic name for Buphenyl is sodium phenylbutyrate. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Buphenyl products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, oral | 3GM/TEASPOONFUL | Discontinued | None | 1 | None |
| tablet, oral | 500MG | Discontinued | None | 3 | AB |
NDA 020573, 020572, held by HORIZON THERAPEUTICS US HOLDING LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic sodium phenylbutyrate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PH HEALTH LTD | 204395 | AB (A-rated, therapeutically equivalent) | April 15, 2016 | 500MG |
| PH HEALTH LTD | 203918 | None (No TE code listed) | June 15, 2016 | 3GM/TEASPOONFUL |
| GLENMARK PHARMACEUTICALS LTD | 216462 | AB (A-rated, therapeutically equivalent) | November 1, 2022 | 500MG |
| NAVINTA LLC | 220418 | AB (A-rated, therapeutically equivalent) | February 17, 2026 | 500MG |
Buphenyl NDC codes
Questions
Is there a generic for Buphenyl?
Yes. The generic name for Buphenyl is sodium phenylbutyrate. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Buphenyl?
The active ingredient in Buphenyl 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.