Active ingredient
Moxifloxacin
57 finished FDA listings contain Moxifloxacin as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- MOXIFLOXACIN, MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE
- Dosage forms
- Injection, Solution, Solution, Solution/ Drops, Tablet, Film Coated
- Routes
- Intravenous, Ophthalmic, Oral
- Manufacturers / labelers
- 36
- Strengths listed
- 400 mg/1 · 400 mg/250ml · 5 mg/ml
- Brand names in FDA listings
- Moxifloxacin, Moxifloxacin Ophthalmic Solution, Vigamox
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 139462
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 |
|---|---|---|---|
| NDA 021598 | HARROW EYE | 2003-04-15 | 2 |
| ANDA 076938 | DR REDDYS | 2014-03-04 | 3 |
| ANDA 202632 | AUROBINDO PHARMA LTD | 2014-03-04 | 15 |
| ANDA 202867 | LUPIN | 2014-09-04 | 5 |
| NDA 205572 | FRESENIUS KABI USA | 2015-04-03 | 2 |
| ANDA 204079 | LUPIN | 2015-05-28 | 1 |
| ANDA 207285 | CHARTWELL RX | 2017-02-13 | 1 |
| ANDA 205833 | MYLAN LABS LTD | 2017-05-05 | 1 |
| ANDA 090080 | APOTEX | 2017-06-30 | 4 |
| ANDA 208682 | MSN | 2017-09-22 | 3 |
| ANDA 206242 | EUGIA PHARMA | 2017-10-04 | 4 |
| ANDA 202916 | EPIC PHARMA LLC | 2017-11-09 | 1 |
| ANDA 206295 | SUNSHINE | 2018-09-28 | 1 |
| ANDA 209469 | ALEMBIC | 2019-02-13 | 3 |
| ANDA 208778 | GLAND | 2020-03-30 | 3 |
| ANDA 212616 | UPSHER SMITH LABS | 2021-02-10 | 2 |
| ANDA 204836 | HETERO LABS LTD V | 2023-03-02 | 1 |
| ANDA 209698 | SOMERSET THERAPS LLC | 2024-11-14 | 2 |
| ANDA 217988 | MANKIND PHARMA | 2025-01-27 | 2 |
| ANDA 209143 | MACLEODS PHARMS | 2026-03-02 | 1 |
Official labeling on DailyMed
- MOXIFLOXACIN HYDROCHLORIDE TABLETS, 400 MG TABLET, FILM COATED [REMEDYREPACK INC.] · version 4 · 2026-09-07
- MOXIFLOXACIN TABLET, FILM COATED [CHARTWELL RX, LLC] · version 1 · 2026-08-19
- MOXIFLOXACIN SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS] · version 1 · 2026-08-06
- MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] · version 11 · 2026-07-06
- MOXIFLOXACIN HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] · version 9 · 2026-05-21
- MOXIFLOXACIN HYDROCHLORIDE SOLUTION/ DROPS [REDPHARM DRUG] · version 1 · 2026-05-20
- MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.] · version 9 · 2026-05-20
- MOXIFLOXACIN OPHTHALMIC SOLUTION (MOXIFLOXACIN) SOLUTION/ DROPS [REDPHARM DRUG] · version 1 · 2026-04-20
- MOXIFLOXACIN HYDROCHLORIDE (MOXIFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AVPAK] · version 6 · 2026-04-09
- MOXIFLOXACIN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] · version 2 · 2026-03-19
- MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] · version 13 · 2026-03-02
- MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] · version 20 · 2026-02-18
Showing the 12 most recent of 54 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.