Xopenex
Xopenex (levalbuterol HCl) Inhalation Solution 0.31 mg*, 0.63 mg*, 1.25 mg*
Approved
Approval ID
35eb525b-72a5-4ef9-a36a-531e9e6b3560
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
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 Code21695-153
Application NumberNDA020837
Product Classification
M
Marketing Category
C73594
G
Generic Name
levalbuterol hydrochloride
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJune 3, 2010
FDA Product Classification
INGREDIENTS (5)
levalbuterol hydrochlorideActive
Quantity: 1.25 mg in 3 mL
Code: WDQ1526QJM
Classification: ACTIB
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
sulfuric acidInactive
Code: O40UQP6WCF
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
nitrogenInactive
Code: N762921K75
Classification: IACT