Tobramycin and Dexamethasone

Product NDC
50090-1136
11-digit product format
500901136
Labeler code
50090
Product ID
50090-1136_97c25fb5-f9a8-470f-83e0-eb6deff071f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tobramycin and Dexamethasone
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
NDA050592
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2009-01-02
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
50090-1136-0500901136005 mL in 1 BOTTLE (50090-1136-0) 5 ml2014-11-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Tobramycin and Dexamethasone Ophthalmic Suspension SterileA-S Medication Solutions2024-08-12HUMAN PRESCRIPTION DRUG LABEL7