Skip to content
LookupMeds

Active ingredient

Ofloxacin

86 finished FDA listings contain Ofloxacin as their only active ingredient.

See all listingsCompare with another medication

FDA NDC Directory

Ingredient names as written by FDA
OFLOXACIN
Dosage forms
Solution, Solution/ Drops, Tablet, Film Coated
Routes
Auricular (Otic), Ophthalmic, Oral
Manufacturers / labelers
32
Strengths listed
200 mg/1 · 3 mg/ml · 300 mg/1 · 400 mg/1
Brand names in FDA listings
Ocuflox, Ofloxacin, Ofloxacin Ophthalmic, Ofloxacin Otic

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 7623

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.

ApplicationSponsorOriginal approvalListings
NDA 019921ALLERGAN1993-07-301
ANDA 076622BAUSCH AND LOMB2004-05-148
ANDA 076513APOTEX INC2004-05-147
ANDA 076527APOTEX INC2007-09-2810
ANDA 076128BAUSCH AND LOMB INC2008-03-173
ANDA 076407SENTISS2008-04-153
ANDA 078559FDC LTD2009-02-254
ANDA 202692ALTAIRE PHARMS INC2013-04-291
ANDA 091656CADILA PHARMS LTD2014-09-186
ANDA 211525AMNEAL2019-08-303
ANDA 215038FDC LTD2022-01-192
ANDA 216130MANKIND PHARMA2022-07-1413
ANDA 215886MANKIND PHARMA2022-11-2312
ANDA 217903CAPLIN2024-01-054
ANDA 217904CAPLIN2024-04-124
ANDA 213597SOMERSET2024-08-011
ANDA 216328SOMERSET THERAPS LLC2024-10-154

Official labeling on DailyMed

Showing the 12 most recent of 71 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.