TOBRAMYCIN AND DEXAMETHASONE

Product NDC
71335-2891
11-digit product format
713352891
Labeler code
71335
Product ID
71335-2891_0ff3c07c-5829-403d-bcce-56dba6e03e42
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tobramycin and dexamethasone
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Bryant Ranch Prepack
Application
ANDA212715
Marketing category
ANDA
Marketing start
2022-03-17
Substance
DEXAMETHASONE; TOBRAMYCIN
Active strength
1; 3 mg/mL; mg/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
7S5I7G3JQLDEXAMETHASONE50-02-2DEXAMETHASONE
VZ8RRZ51VKTOBRAMYCIN32986-56-4TOBRAMYCIN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2891-17133528910110 mL in 1 BOTTLE, PLASTIC (71335-2891-1) 10 ml2025-10-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Tobramycin and Dexamethasone Ophthalmic Suspension, USP SterileBryant Ranch Prepack2025-10-21HUMAN PRESCRIPTION DRUG LABEL100