NDC Code(s) : 54569-2867-0
Packager : A-S Medication Solutions LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Polytrimpolymyxin b sulfate and trimethoprim sulfate SOLUTION/ DROPS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54569-2867(NDC:0023-7824)
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
polymyxin b sulfate(UNII: 19371312D4)
(polymyxin b - UNII:J2VZ07J96K) 		polymyxin b100000 [USP'U] in 1 mL
trimethoprim sulfate(UNII: E377MF8EQ8)
(trimethoprim - UNII:AN164J8Y0X) 		trimethoprim1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
sodium chloride(UNII: 451W47IQ8X)
sulfuric acid(UNII: O40UQP6WCF)
benzalkonium chloride(UNII: F5UM2KM3W7)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54569-2867-01 in 1 CARTON
110 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050567 01/23/1990

PRINCIPAL DISPLAY PANEL

NDC 54569-2867-0

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


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