NDC Code(s) : 55154-2779-6
Packager : Cardinal Health

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Xopenexlevalbuterol hydrochloride SOLUTION, CONCENTRATE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-2779(NDC:63402-515)
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
levalbuterol hydrochloride(UNII: WDQ1526QJM)
(levalbuterol - UNII:EDN2NBH5SS) 		levalbuterol1.25 mg in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
sodium chloride(UNII: 451W47IQ8X)
hydrochloric acid(UNII: QTT17582CB)
water(UNII: 059QF0KO0R)
nitrogen(UNII: N762921K75)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-2779-66 in 1 BAG
11 in 1 POUCH
10.5 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020837 08/01/2004

PRINCIPAL DISPLAY PANEL

Xopenex Inhalation Solution Concentrate

1.25 mg/0.5 mL*

Levalbuterol HCl

6 x 0.5 mL Sterile Unit-Dose Vials

bag label