FDA Orange Book
Generic for Cataflam
Cataflam 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 Cataflam is diclofenac. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Cataflam products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 25MG | Discontinued | None | 4 | AB |
| tablet, oral | 50MG | Discontinued | None | 7 | AB |
NDA 020142, 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 |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 075219 | AB (A-rated, therapeutically equivalent) | August 6, 1998 | 50MG |
| RISING PHARMA HOLDINGS INC | 075463 | AB (A-rated, therapeutically equivalent) | July 26, 1999 | 50MG |
| PANGEA PHARMACEUTICALS LLC | 076561 | AB (A-rated, therapeutically equivalent) | July 21, 2021 | 25MG, 50MG |
| RUBICON RESEARCH LTD | 075229 | AB (A-rated, therapeutically equivalent) | September 16, 2021 | 25MG, 50MG |
| INGENUS PHARMACEUTICALS LLC | 215585 | AB (A-rated, therapeutically equivalent) | October 8, 2021 | 50MG |
| PHARMAZONE | 215787 | AB (A-rated, therapeutically equivalent) | November 9, 2023 | 25MG, 50MG |
| UMEDICA LABORATORIES PRIVATE LTD | 215750 | AB (A-rated, therapeutically equivalent) | June 30, 2025 | 25MG, 50MG |
Questions
Is there a generic for Cataflam?
Yes. The generic name for Cataflam is diclofenac. 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 Cataflam?
The active ingredient in Cataflam 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.