NDC Code(s) : 50090-1136-0
Packager : A-S Medication Solutions

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Tobramycin and Dexamethasone Tobramycin and Dexamethasone SUSPENSION/ DROPS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-1136(NDC:61314-647)
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 mL
DEXAMETHASONE(UNII: 7S5I7G3JQL)
(DEXAMETHASONE - UNII:7S5I7G3JQL) 		DEXAMETHASONE1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
TYLOXAPOL(UNII: Y27PUL9H56)
EDETATE DISODIUM(UNII: 7FLD91C86K)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SODIUM SULFATE(UNII: 0YPR65R21J)
SULFURIC ACID(UNII: O40UQP6WCF)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)(UNII: S38J6RZN16)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50090-1136-05 mL in 1 BOTTLE Type 0: Not a Combination Product28/11/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA050592 01/02/2009 02/28/2017

PRINCIPAL DISPLAY PANEL

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