FDA Orange Book
Generic for Floxin Otic
Floxin Otic 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 Floxin Otic is ofloxacin. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.
Run it in Rivvi
Map Floxin Otic 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.
Floxin Otic products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution/drops, otic | 0.3% | Discontinued | None | 7 | AT |
NDA 020799, held by DAIICHI PHARMACEUTICAL CORP. 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 | 076527 | AT (A-rated, therapeutically equivalent) | September 28, 2007 | 0.3% |
| BAUSCH AND LOMB INC | 076128 | AT (A-rated, therapeutically equivalent) | March 17, 2008 | 0.3% |
| AMNEAL EU LTD | 211525 | AT (A-rated, therapeutically equivalent) | August 30, 2019 | 0.3% |
| FDC LTD | 215038 | AT (A-rated, therapeutically equivalent) | January 19, 2022 | 0.3% |
| MANKIND PHARMA LTD | 216130 | AT (A-rated, therapeutically equivalent) | July 14, 2022 | 0.3% |
| CAPLIN STERILES LTD | 217903 | AT (A-rated, therapeutically equivalent) | January 5, 2024 | 0.3% |
| SOMERSET THERAPEUTICS LLC | 216328 | AT (A-rated, therapeutically equivalent) | October 15, 2024 | 0.3% |
Questions
Is there a generic for Floxin Otic?
Yes. The generic name for Floxin Otic is ofloxacin. 7 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 Floxin Otic?
The active ingredient in Floxin Otic 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.