FDA Orange Book
Generic for Dolobid
Dolobid contains diflunisal. 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 Dolobid is diflunisal. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Dolobid products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 250MG | Discontinued | None | 1 | None |
| tablet, oral | 500MG | Discontinued | None | 3 | AB |
NDA 018445, held by MERCK AND CO INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic diflunisal
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 073673 | AB (A-rated, therapeutically equivalent) | July 31, 1992 | 500MG |
| ZYDUS PHARMACEUTICALS USA INC | 203547 | AB (A-rated, therapeutically equivalent) | June 16, 2017 | 500MG |
| HERITAGE PHARMA LABS INC | 202845 | None (No TE code listed) | August 16, 2024 | 250MG, 500MG |
Questions
Is there a generic for Dolobid?
Yes. The generic name for Dolobid is diflunisal. 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 Dolobid?
The active ingredient in Dolobid is diflunisal, 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.