Levalbuterol
These highlights do not include all the information needed to use LEVALBUTEROL INHALATION SOLUTION safely and effectively. See full prescribing information for LEVALBUTEROL INHALATION SOLUTION. LEVALBUTEROL inhalation solution, for inhalation useInitial U.S. Approval: 1999
Approved
Approval ID
97699821-81f8-4623-8504-e479c0f4b183
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2019
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
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 Code63187-953
Application NumberANDA090297
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levalbuterol
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateDecember 1, 2018
FDA Product Classification
INGREDIENTS (6)
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
LEVALBUTEROL HYDROCHLORIDEActive
Quantity: 0.63 mg in 3 mL
Code: WDQ1526QJM
Classification: ACTIM
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT