FDA Orange Book
Generic for Durezol
Durezol contains difluprednate. 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 Durezol is difluprednate. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Durezol products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| emulsion, ophthalmic | 0.05% | Marketed (Rx) | AB | 7 | AB |
NDA 022212, held by SANDOZ INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic difluprednate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AMNEAL EU LTD | 211526 | AB (A-rated, therapeutically equivalent) | November 17, 2021 | 0.05% |
| DR REDDYS LABORATORIES LTD | 214894 | AB (A-rated, therapeutically equivalent) | November 16, 2022 | 0.05% |
| EPIC PHARMA LLC | 207284 | AB (A-rated, therapeutically equivalent) | May 14, 2024 | 0.05% |
| CAPLIN STERILES LTD | 219441 | AB (A-rated, therapeutically equivalent) | December 13, 2024 | 0.05% |
| UPSHER SMITH LABORATORIES LLC | 218191 | AB (A-rated, therapeutically equivalent) | February 11, 2025 | 0.05% |
| MYLAN LABORATORIES LTD | 212566 | AB (A-rated, therapeutically equivalent) | March 20, 2025 | 0.05% |
| ALEMBIC PHARMACEUTICALS LTD | 213774 | AB (A-rated, therapeutically equivalent) | January 26, 2026 | 0.05% |
Durezol NDC codes
Questions
Is there a generic for Durezol?
Yes. The generic name for Durezol is difluprednate. 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 Durezol?
The active ingredient in Durezol is difluprednate, 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.