Tobramycin and Dexamethasone

Product NDC
68788-4081
11-digit product format
687884081
Labeler code
68788
Product ID
68788-4081_8a143864-e36b-49bf-91b4-c6cc1a928031
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tobramycin and Dexamethasone
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Preferred Pharmaceuticals Inc.
Application
NDA050592
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2026-02-26
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
2027-12-31
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
68788-4081-5687884081051 BOTTLE in 1 CARTON (68788-4081-5) / 5 mL in 1 BOTTLE1 bottle2026-02-26NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Tobramycin and Dexamethasone Ophthalmic Suspension Sterile Rx OnlyPreferred Pharmaceuticals Inc.2026-02-26HUMAN PRESCRIPTION DRUG LABEL1