Tobramycin and dexamethasone

Product NDC
80425-0260
11-digit product format
804250260
Labeler code
80425
Product ID
80425-0260_2a9b792b-f417-e859-e063-6394a90a30e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tobramycin and dexamethasone
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA212715
Marketing category
ANDA
Marketing start
2023-02-15
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
80425-0260-1804250260015 mL in 1 BOTTLE, PLASTIC (80425-0260-1) 5 ml2023-02-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Tobramycin and Dexamethasone Ophthalmic SuspensionAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL2