FDA Orange Book
Generic for Voltaren
Voltaren contains diclofenac. 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 Voltaren is diclofenac. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AT.
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Voltaren products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution/drops, ophthalmic | 0.1% | Discontinued | None | 5 | AT |
| tablet, delayed release, oral | 25MG | Discontinued | None | 4 | AB |
| tablet, delayed release, oral | 50MG | Discontinued | None | 6 | AB |
| tablet, delayed release, oral | 75MG | Discontinued | None | 6 | AB |
NDA 020037, 019201, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic diclofenac
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS ELIZABETH LLC | 074514 | AB (A-rated, therapeutically equivalent) | March 26, 1996 | 50MG, 75MG |
| CARLSBAD TECHNOLOGY INC | 075185 | AB (A-rated, therapeutically equivalent) | November 13, 1998 | 25MG, 50MG, 75MG |
| AUROBINDO PHARMA USA INC | 075281 | AB (A-rated, therapeutically equivalent) | February 12, 2002 | 50MG, 75MG |
| UNIQUE PHARMACEUTICAL LABORATORIES A DIV OF JB CHEMICALS AND PHARMACEUTICALS LTD | 077863 | AB (A-rated, therapeutically equivalent) | June 8, 2007 | 75MG |
| BAUSCH AND LOMB INC | 078792 | AT (A-rated, therapeutically equivalent) | December 28, 2007 | 0.1% |
| RISING PHARMA HOLDINGS INC | 078553 | AT (A-rated, therapeutically equivalent) | December 28, 2007 | 0.1% |
| SANDOZ INC | 078031 | AT (A-rated, therapeutically equivalent) | February 6, 2008 | 0.1% |
| RUBICON RESEARCH LTD | 077600 | AT (A-rated, therapeutically equivalent) | November 13, 2008 | 0.1% |
| UNIQUE PHARMACEUTICAL LABORATORIES A DIV OF JB CHEMICALS AND PHARMACEUTICALS LTD | 090066 | AB (A-rated, therapeutically equivalent) | December 1, 2010 | 25MG, 50MG |
| ALTAIRE PHARMACEUTICALS INC | 203383 | AT (A-rated, therapeutically equivalent) | November 16, 2015 | 0.1% |
| RUBICON RESEARCH LTD | 216548 | AB (A-rated, therapeutically equivalent) | May 11, 2023 | 25MG, 50MG, 75MG |
| UMEDICA LABORATORIES PRIVATE LTD | 219945 | AB (A-rated, therapeutically equivalent) | November 5, 2025 | 25MG, 50MG, 75MG |
Questions
Is there a generic for Voltaren?
Yes. The generic name for Voltaren is diclofenac. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AT.
What is the generic name for Voltaren?
The active ingredient in Voltaren is diclofenac, 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.