Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Rebel Distributors Corp
Rebel Distributors Corp
118802834
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Xopenex
Product Details
NDC Product Code
21695-153Application Number
NDA020837Marketing Category
NDA (C73594)Route of Administration
RESPIRATORY (INHALATION)Effective Date
June 3, 2010LevosalbutamolActive
Code: WDQ1526QJMClass: ACTIBQuantity: 1.25 mg in 3 mL
sodium chlorideInactive
Code: 451W47IQ8XClass: IACT
sulfuric acidInactive
Code: O40UQP6WCFClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
nitrogenInactive
Code: N762921K75Class: IACT