FDA Orange Book
Generic for Ocufen
Ocufen contains flurbiprofen. 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 Ocufen is flurbiprofen. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
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Ocufen products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution/drops, ophthalmic | 0.03% | Discontinued | None | 1 | None |
NDA 019404, held by ALLERGAN PHARMACEUTICAL. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic flurbiprofen
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BAUSCH AND LOMB INC | 074447 | None (No TE code listed) | January 4, 1995 | 0.03% |
Questions
Is there a generic for Ocufen?
Yes. The generic name for Ocufen is flurbiprofen. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
What is the generic name for Ocufen?
The active ingredient in Ocufen is flurbiprofen, 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.