FDA Orange Book
Generic for Ocuflox
Ocuflox contains ofloxacin. 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 Ocuflox is ofloxacin. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.
Run it in Rivvi
Map Ocuflox and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Ocuflox products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution/drops, ophthalmic | 0.3% | Marketed (Rx) | AT | 9 | AT |
NDA 019921, held by ALLERGAN INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ofloxacin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| APOTEX INC | 076513 | AT (A-rated, therapeutically equivalent) | May 14, 2004 | 0.3% |
| BAUSCH AND LOMB INC | 076622 | AT (A-rated, therapeutically equivalent) | May 14, 2004 | 0.3% |
| SENTISS AG | 076407 | AT (A-rated, therapeutically equivalent) | April 15, 2008 | 0.3% |
| FDC LTD | 078559 | AT (A-rated, therapeutically equivalent) | February 25, 2009 | 0.3% |
| ALTAIRE PHARMACEUTICALS INC | 202692 | AT (A-rated, therapeutically equivalent) | April 29, 2013 | 0.3% |
| MANKIND PHARMA LTD | 215886 | AT (A-rated, therapeutically equivalent) | November 23, 2022 | 0.3% |
| CAPLIN STERILES LTD | 217904 | AT (A-rated, therapeutically equivalent) | April 12, 2024 | 0.3% |
| SOMERSET THERAPEUTICS LLC | 213597 | AT (A-rated, therapeutically equivalent) | August 1, 2024 | 0.3% |
| MICRO LABS LTD | 218557 | AT (A-rated, therapeutically equivalent) | April 8, 2026 | 0.3% |
Ocuflox NDC codes
Questions
Is there a generic for Ocuflox?
Yes. The generic name for Ocuflox is ofloxacin. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.
What is the generic name for Ocuflox?
The active ingredient in Ocuflox is ofloxacin, 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.