Tobramycin

Product NDC
76420-092
11-digit product format
764200092
Labeler code
76420
Product ID
76420-092_b2696acf-8175-16fb-e053-2a95a90aa378
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tobramycin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Asclemed USA, Inc.
Application
ANDA207444
Marketing category
ANDA
Marketing start
2017-06-28
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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-092-05764200092055 mL in 1 BOTTLE (76420-092-05) 5 ml2020-10-24NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Rx Only For Topical Ophthalmic Use OnlyAsclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2020-10-24HUMAN PRESCRIPTION DRUG LABEL1