FDA Orange Book
Generic for Levaquin
Levaquin contains levofloxacin. 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 Levaquin is levofloxacin. 14 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB, AP.
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Levaquin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 500MG/20ML (EQ 25MG/ML) | Discontinued | None | 2 | AP |
| injectable, injection | EQ 750MG/30ML (EQ 25MG/ML) | Discontinued | None | 2 | AP |
| solution, oral | 250MG/10ML | Discontinued | None | 2 | AA |
| tablet, oral | 250MG | Discontinued | None | 10 | AB |
| tablet, oral | 500MG | Discontinued | None | 10 | AB |
| tablet, oral | 750MG | Discontinued | None | 10 | AB |
NDA 020635, 021721, 020634, held by JANSSEN PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic levofloxacin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| RISING PHARMA HOLDINGS INC | 091644 | AP (A-rated, therapeutically equivalent) | June 20, 2011 | EQ 500MG/20ML (EQ 25MG/ML), EQ 750MG/30ML (EQ 25MG/ML) |
| NOVITIUM PHARMA LLC | 091678 | AA (A-rated, therapeutically equivalent) | June 20, 2011 | 250MG/10ML |
| AUROBINDO PHARMA LIMITED | 201043 | AB (A-rated, therapeutically equivalent) | June 20, 2011 | 250MG, 500MG, 750MG |
| DR REDDYS LABORATORIES INC | 076710 | AB (A-rated, therapeutically equivalent) | June 20, 2011 | 250MG, 500MG, 750MG |
| GLENMARK PHARMACEUTICALS LTD | 200250 | AB (A-rated, therapeutically equivalent) | June 20, 2011 | 250MG, 500MG, 750MG |
| TEVA PHARMACEUTICALS USA INC | 076361 | AB (A-rated, therapeutically equivalent) | June 20, 2011 | 250MG, 500MG, 750MG |
| ORBION PHARMACEUTICALS PRIVATE LTD | 202200 | AB (A-rated, therapeutically equivalent) | January 30, 2012 | 250MG, 500MG, 750MG |
| MACLEODS PHARMACEUTICALS LTD | 200839 | AB (A-rated, therapeutically equivalent) | March 22, 2012 | 250MG, 500MG, 750MG |
| CHARTWELL MOLECULAR HOLDINGS LLC | 076890 | AB (A-rated, therapeutically equivalent) | March 30, 2012 | 250MG, 500MG, 750MG |
| ZYDUS LIFESCIENCES LTD | 077652 | AB (A-rated, therapeutically equivalent) | September 7, 2012 | 250MG, 500MG, 750MG |
| HETERO LABS LTD UNIT V | 202801 | AB (A-rated, therapeutically equivalent) | January 8, 2015 | 250MG, 500MG, 750MG |
| LANNETT CO INC | 205222 | AA (A-rated, therapeutically equivalent) | May 25, 2018 | 250MG/10ML |
| HEC PHARM USA INC | 204968 | AB (A-rated, therapeutically equivalent) | February 5, 2019 | 250MG, 500MG, 750MG |
| GLAND PHARMA LTD | 205540 | AP (A-rated, therapeutically equivalent) | April 22, 2020 | EQ 500MG/20ML (EQ 25MG/ML), EQ 750MG/30ML (EQ 25MG/ML) |
Questions
Is there a generic for Levaquin?
Yes. The generic name for Levaquin is levofloxacin. 14 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB, AP.
What is the generic name for Levaquin?
The active ingredient in Levaquin is levofloxacin, 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.