Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Physicians Total Care, Inc.
Physicians Total Care, Inc.
194123980
Products3
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
54868-5459Application Number
NDA020837Marketing Category
NDA (C73594)Route of Administration
RESPIRATORY (INHALATION)Effective Date
December 1, 2009LevosalbutamolActive
Code: WDQ1526QJMClass: ACTIBQuantity: 1.25 mg in 3 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
Xopenex
Product Details
NDC Product Code
54868-4409Application Number
NDA020837Marketing Category
NDA (C73594)Route of Administration
RESPIRATORY (INHALATION)Effective Date
December 1, 2009LevosalbutamolActive
Code: WDQ1526QJMClass: ACTIBQuantity: 0.63 mg in 3 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
Xopenex
Product Details
NDC Product Code
54868-6021Application Number
NDA020837Marketing Category
NDA (C73594)Route of Administration
RESPIRATORY (INHALATION)Effective Date
December 1, 2009LevosalbutamolActive
Code: WDQ1526QJMClass: ACTIBQuantity: 1.25 mg in 0.5 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT