NDC Code(s) : 54569-2590-0
Packager : A-S Medication Solutions LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TobraDextobramycin and dexamethasone OINTMENT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54569-2590(NDC:0065-0648)
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TOBRAMYCIN(UNII: VZ8RRZ51VK)
(TOBRAMYCIN - UNII:VZ8RRZ51VK) 		TOBRAMYCIN3 mg in 1 g
DEXAMETHASONE(UNII: 7S5I7G3JQL)
(DEXAMETHASONE - UNII:7S5I7G3JQL) 		DEXAMETHASONE1 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CHLOROBUTANOL(UNII: HM4YQM8WRC)
MINERAL OIL(UNII: T5L8T28FGP)
PETROLATUM(UNII: 4T6H12BN9U)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54569-2590-03.5 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050616 10/15/1988

PRINCIPAL DISPLAY PANEL

NDC 54569-2590-0

Relabeled by:
A-S Medication Solutions
Libertyville, IL 60048


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