Levalbuterol
These highlights do not include all the information needed to use LEVALBUTEROL INHALATION SOLUTION (CONCENTRATE) safely and effectively. See full prescribing information for LEVALBUTEROL INHALATION SOLUTION (CONCENTRATE). LEVALBUTEROL inhalation solution (concentrate)Initial U.S. Approval: 1999
Approved
Approval ID
206bbdec-04f0-40e3-a259-32fc6bce20d8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 11, 2019
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
levalbuterol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-6993
Application NumberANDA078309
Product Classification
M
Marketing Category
C73584
G
Generic Name
levalbuterol
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateAugust 29, 2017
FDA Product Classification
INGREDIENTS (5)
LEVALBUTEROL HYDROCHLORIDEActive
Quantity: 1.25 mg in 0.5 mL
Code: WDQ1526QJM
Classification: ACTIM
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT