FDA Orange Book
Generic for Campral
Campral contains acamprosate. 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 Campral is acamprosate. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Campral products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, delayed release, oral | 333MG | Discontinued | None | 5 | AB |
NDA 021431, held by FOREST LABORATORIES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic acamprosate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| GLENMARK PHARMACEUTICALS LTD | 202229 | AB (A-rated, therapeutically equivalent) | July 16, 2013 | 333MG |
| MYLAN PHARMACEUTICALS INC | 200142 | AB (A-rated, therapeutically equivalent) | March 11, 2014 | 333MG |
| ZYDUS PHARMACEUTICALS USA INC | 205995 | AB (A-rated, therapeutically equivalent) | May 26, 2017 | 333MG |
| BIONPHARMA INC | 219904 | AB (A-rated, therapeutically equivalent) | September 18, 2025 | 333MG |
| SOMERSET THERAPEUTICS LLC | 218984 | AB (A-rated, therapeutically equivalent) | March 16, 2026 | 333MG |
Questions
Is there a generic for Campral?
Yes. The generic name for Campral is acamprosate. 5 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 Campral?
The active ingredient in Campral is acamprosate, 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.