Gentamicin Sulfate

Product NDC
68071-3554
11-digit product format
680713554
Labeler code
68071
Product ID
68071-3554_2d3fc60b-5a42-6abc-e063-6394a90af2a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gentamicin Sulfate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA064048
Marketing category
ANDA
Marketing start
1994-05-11
Substance
GENTAMICIN SULFATE
Active strength
3 mg/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
8X7386QRLVGENTAMICIN SULFATE1405-41-0GENTAMICIN SULFATE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-3554-5680713554051 BOTTLE, DROPPER in 1 CARTON (68071-3554-5) / 5 mL in 1 BOTTLE, DROPPER2023-12-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Gentamicin Sulfate Ophthalmic Solution, USP 0.3% (Sterile) Rx onlyNuCare Pharmaceuticals,Inc.2025-02-03HUMAN PRESCRIPTION DRUG LABEL2