NDC Code(s) : 50436-0736-1
Packager : Unit Dose Services

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone SOLUTION/ DROPS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50436-0736(NDC:24208-631)
Route of Administration AURICULAR (OTIC) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NEOMYCIN SULFATE(UNII: 057Y626693)
(NEOMYCIN - UNII:I16QD7X297) 		NEOMYCIN3.5 mg in 1 mL
POLYMYXIN B SULFATE(UNII: 19371312D4)
(POLYMYXIN B - UNII:J2VZ07J96K) 		POLYMYXIN B10000 [USP'U] in 1 mL
HYDROCORTISONE(UNII: WI4X0X7BPJ)
(HYDROCORTISONE - UNII:WI4X0X7BPJ) 		HYDROCORTISONE10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
HYDROCHLORIC ACID(UNII: QTT17582CB)
POTASSIUM METABISULFITE(UNII: 65OE787Q7W)
CUPRIC SULFATE(UNII: LRX7AJ16DT)
GLYCERIN(UNII: PDC6A3C0OX)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50436-0736-1 10 mL in 1 BOTTLE, DROPPER Type 0: Not a Combination Product29/12/1995
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA064053 12/29/1995

PRINCIPAL DISPLAY PANEL

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