NDC Code(s) : 54569-5988-0
Packager : A-S Medication Solutions LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Butorphanol TartrateButorphanol Tartrate SPRAY, METERED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54569-5988(NDC:0054-3090)
Route of Administration NASAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUTORPHANOL TARTRATE(UNII: 2L7I72RUHN)
(BUTORPHANOL - UNII:QV897JC36D) 		BUTORPHANOL TARTRATE10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZETHONIUM CHLORIDE(UNII: PH41D05744)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
HYDROCHLORIC ACID(UNII: QTT17582CB)
WATER(UNII: 059QF0KO0R)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54569-5988-01 in 1 CONTAINER
12.5 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075824 03/12/2002

PRINCIPAL DISPLAY PANEL

NDC 54569-5988-0

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


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