FDA Orange Book
Generic for Floxin
Floxin 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 is ofloxacin. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 5 Floxin products the Orange Book lists.
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Floxin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 20MG/ML | Discontinued | None | 0 | None |
| injectable, injection | 40MG/ML | Discontinued | None | 0 | None |
| tablet, oral | 200MG | Discontinued | None | 3 | AB |
| tablet, oral | 300MG | Discontinued | None | 3 | AB |
| tablet, oral | 400MG | Discontinued | None | 4 | AB |
NDA 020087, 019735, held by ORTHO MCNEIL PHARMACEUTICAL 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 |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 076182 | AB (A-rated, therapeutically equivalent) | September 2, 2003 | 200MG, 300MG, 400MG |
| CHARTWELL RX SCIENCES LLC | 076093 | AB (A-rated, therapeutically equivalent) | September 2, 2003 | 400MG |
| DR REDDYS LABORATORIES LTD | 077098 | AB (A-rated, therapeutically equivalent) | February 10, 2006 | 200MG, 300MG, 400MG |
| CADILA PHARMACEUTICALS LTD | 091656 | AB (A-rated, therapeutically equivalent) | September 18, 2014 | 200MG, 300MG, 400MG |
Questions
Is there a generic for Floxin?
Yes. The generic name for Floxin is ofloxacin. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 5 Floxin products the Orange Book lists.
What is the generic name for Floxin?
The active ingredient in Floxin 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.