Active ingredient
Levofloxacin
121 finished FDA listings contain Levofloxacin as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- LEVOFLOXACIN
- Dosage forms
- Injection, Injection, Solution, Injection, Solution, Concentrate, Solution, Solution/ Drops, Tablet, Tablet, Film Coated
- Routes
- Intravenous, Ophthalmic, Oral
- Manufacturers / labelers
- 45
- Strengths listed
- 15 mg/ml · 25 mg/ml · 250 mg/1 · 250 mg/50ml · 5 mg/ml · 500 mg/1 · 500 mg/100ml · 500 mg/20ml · 750 mg/1 · 750 mg/150ml · 750 mg/30ml
- Brand names in FDA listings
- Levofloxacin
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 82122
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 078282 | RUBICON RESEARCH | 2010-12-20 | 1 |
| ANDA 091678 | NOVITIUM PHARMA | 2011-06-20 | 1 |
| ANDA 201043 | AUROBINDO PHARMA LTD | 2011-06-20 | 17 |
| ANDA 076710 | DR REDDYS LABS INC | 2011-06-20 | 16 |
| ANDA 078424 | LUPIN | 2011-06-20 | 3 |
| ANDA 090343 | INFORLIFE | 2011-07-07 | 7 |
| ANDA 091375 | HIKMA FARMACEUTICA | 2011-09-16 | 6 |
| ANDA 200839 | MACLEODS PHARMS LTD | 2012-03-22 | 4 |
| ANDA 076890 | CHARTWELL MOLECULAR | 2012-03-30 | 3 |
| ANDA 077652 | ZYDUS LIFESCIENCES | 2012-09-07 | 18 |
| ANDA 202328 | EUGIA PHARMA | 2013-01-24 | 2 |
| ANDA 091436 | BAXTER HLTHCARE CORP | 2013-06-05 | 1 |
| ANDA 200674 | FRESENIUS KABI USA | 2013-06-19 | 1 |
| ANDA 202801 | HETERO LABS LTD V | 2015-01-08 | 31 |
| ANDA 206919 | EUGIA PHARMA | 2016-02-10 | 3 |
| ANDA 205222 | LANNETT CO INC | 2018-05-25 | 1 |
| ANDA 205600 | MICRO LABS LTD INDIA | 2019-02-27 | 1 |
| ANDA 205540 | GLAND | 2020-04-22 | 2 |
| ANDA 206908 | GLAND | 2020-12-30 | 3 |
Official labeling on DailyMed
- LEVOFLOXACIN TABLET, FILM COATED [REDPHARM DRUG] · version 1 · 2026-09-02
- LEVOFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS] · version 7 · 2026-09-02
- LEVOFLOXACIN TABLET, FILM COATED [COUPLER LLC] · version 1 · 2026-08-28
- LEVOFLOXACIN TABLET, FILM COATED [REMEDYREPACK INC.] · version 8 · 2026-08-20
- LEVOFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 1 · 2026-08-13
- LEVOFLOXACIN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] · version 22 · 2026-07-27
- LEVOFLOXACIN TABLET, FILM COATED [HAWAII REPACK, INC.] · version 1 · 2026-07-23
- LEVOFLOXACIN TABLET, FILM COATED [REMEDYREPACK INC.] · version 19 · 2026-07-06
- LEVOFLOXACIN TABLET, FILM COATED [REMEDYREPACK INC.] · version 18 · 2026-07-03
- LEVOFLOXACIN TABLET [CHARTWELL RX, LLC] · version 3 · 2026-06-30
- LEVOFLOXACIN TABLET, FILM COATED [REMEDYREPACK INC.] · version 22 · 2026-06-29
- LEVOFLOXACIN TABLET, FILM COATED [CARDINAL HEALTH 107, LLC] · version 19 · 2026-06-01
Showing the 12 most recent of 78 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.