Tobramycin

Product NDC
76420-791
11-digit product format
764200791
Labeler code
76420
Product ID
76420-791_14111f01-7d9a-6602-e063-6294a90a47a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tobramycin
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Asclemed USA, Inc.
Application
ANDA064052
Marketing category
ANDA
Marketing start
1993-11-29
Substance
TOBRAMYCIN
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
VZ8RRZ51VKTOBRAMYCIN32986-56-4TOBRAMYCIN

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76420-791-05764200791051 BOTTLE, DROPPER in 1 CARTON (76420-791-05) / 5 mL in 1 BOTTLE, DROPPER2024-03-20NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Tobramycin Ophthalmic Solution, USP 0.3% (Sterile) Rx onlyAsclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2024-03-20HUMAN PRESCRIPTION DRUG LABEL1