FDA Orange Book
Generic for Revia
Revia contains naltrexone. 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 Revia is naltrexone. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Revia products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 50MG | Discontinued | None | 7 | AB |
NDA 018932, held by TEVA WOMENS HEALTH INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic naltrexone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BARR LABORATORIES INC | 074918 | AB (A-rated, therapeutically equivalent) | May 8, 1998 | 50MG |
| ELITE LABORATORIES INC | 075274 | AB (A-rated, therapeutically equivalent) | May 26, 1999 | 50MG |
| NOVITIUM PHARMA LLC | 075434 | AB (A-rated, therapeutically equivalent) | March 8, 2000 | 50MG |
| SPECGX LLC | 076264 | AB (A-rated, therapeutically equivalent) | March 22, 2002 | 50MG |
| ACCORD HEALTHCARE INC | 091205 | AB (A-rated, therapeutically equivalent) | August 17, 2011 | 50MG |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 090356 | AB (A-rated, therapeutically equivalent) | February 24, 2012 | 50MG |
| CHARTWELL LIFE MOLECULES LLC | 207905 | AB (A-rated, therapeutically equivalent) | July 21, 2017 | 50MG |
Questions
Is there a generic for Revia?
Yes. The generic name for Revia is naltrexone. 7 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 Revia?
The active ingredient in Revia is naltrexone, 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.