Xopenex
Approved
Approval ID
1700a5b8-4029-424a-bfed-15f6737dd210
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2009
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
levalbuterol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5459
Application NumberNDA020837
Product Classification
M
Marketing Category
C73594
G
Generic Name
levalbuterol hydrochloride
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateDecember 1, 2009
FDA Product Classification
INGREDIENTS (3)
LEVALBUTEROL HYDROCHLORIDEActive
Quantity: 1.25 mg in 3 mL
Code: WDQ1526QJM
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
levalbuterol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4409
Application NumberNDA020837
Product Classification
M
Marketing Category
C73594
G
Generic Name
levalbuterol hydrochloride
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateDecember 1, 2009
FDA Product Classification
INGREDIENTS (3)
LEVALBUTEROL HYDROCHLORIDEActive
Quantity: 0.63 mg in 3 mL
Code: WDQ1526QJM
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
levalbuterol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6021
Application NumberNDA020837
Product Classification
M
Marketing Category
C73594
G
Generic Name
levalbuterol hydrochloride
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateDecember 1, 2009
FDA Product Classification
INGREDIENTS (3)
LEVALBUTEROL HYDROCHLORIDEActive
Quantity: 1.25 mg in 0.5 mL
Code: WDQ1526QJM
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT