Levalbuterol
Levalbuterol Inhalation Solution, USP These highlights do not include all the information needed to use LEVALBUTEROL INHALATION SOLUTION, USP safely and effectively. See full prescribing information for LEVALBUTEROL INHALATION SOLUTION, USP. LEVALBUTEROL INHALATION SOLUTION, USP, for inhalation use Initial U.S. Approval: 1999 Rx only
Approved
Approval ID
d6998949-e1cb-4c86-a480-c0dfd9cb75b5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2023
Manufacturers
FDA
Ritedose Pharmaceuticals, LLC
DUNS: 968062294
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
NDC Product Code76204-800
Application NumberANDA203653
Marketing CategoryC73584
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateDecember 20, 2023
Generic NameLevalbuterol Hydrochloride
INGREDIENTS (2)
LEVALBUTEROL HYDROCHLORIDEActive
Quantity: 0.63 mg in 3 mL
Code: WDQ1526QJM
Classification: ACTIM
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
Levalbuterol Hydrochloride
PRODUCT DETAILS
NDC Product Code76204-900
Application NumberANDA203653
Marketing CategoryC73584
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateDecember 20, 2023
Generic NameLevalbuterol Hydrochloride
INGREDIENTS (2)
LEVALBUTEROL HYDROCHLORIDEActive
Quantity: 1.25 mg in 3 mL
Code: WDQ1526QJM
Classification: ACTIM
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
Levalbuterol Hydrochloride
PRODUCT DETAILS
NDC Product Code76204-700
Application NumberANDA203653
Marketing CategoryC73584
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateDecember 20, 2023
Generic NameLevalbuterol Hydrochloride
INGREDIENTS (2)
LEVALBUTEROL HYDROCHLORIDEActive
Quantity: 0.31 mg in 3 mL
Code: WDQ1526QJM
Classification: ACTIM
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT