Skip to content
LookupMeds

Active ingredient

Gentamicin

47 finished FDA listings contain Gentamicin as their only active ingredient.

See all listingsCompare with another medication

FDA NDC Directory

Ingredient names as written by FDA
GENTAMICIN, GENTAMICIN SULFATE
Dosage forms
Cream, Injection, Solution, Ointment, Solution, Solution/ Drops
Routes
Intramuscular, Intravenous, Ophthalmic, Topical
Manufacturers / labelers
23
Strengths listed
1 mg/g · 10 mg/ml · 100 mg/100ml · 100 mg/50ml · 3 mg/g · 3 mg/ml · 40 mg/ml · 60 mg/50ml · 80 mg/100ml · 80 mg/50ml
Brand names in FDA listings
Gentak, Gentamicin, Gentamicin Sulfate In Sodium Chloride

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 1596450

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
ANDA 062251HIKMA1980-06-052
ANDA 062196SANDOZ1980-07-024
ANDA 062307PADAGIS US1981-05-151
ANDA 062351PADAGIS US1982-02-181
ANDA 062373BAXTER HLTHCARE1982-09-075
ANDA 062366FRESENIUS KABI USA1983-08-049
ANDA 062420HOSPIRA1983-08-156
ANDA 062452ALLERGAN1984-10-102
ANDA 064054COSETTE PHARMS NC1994-04-292
ANDA 064056COSETTE PHARMS NC1994-04-291
ANDA 064048BAUSCH AND LOMB INC1994-05-117
ANDA 064093SCIEGEN PHARMS1995-08-311
ANDA 064163PHARMOBEDIENT2001-10-122
ANDA 215236EUGIA PHARMA2024-01-081
ANDA 215237EUGIA PHARMA2024-01-083

Official labeling on DailyMed

Showing the 12 most recent of 40 labels.

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