Levalbuterol Inhalation Solution
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 Initial U.S. Approval: 1999
Approved
Approval ID
85a59e0c-ff09-49a6-b7b8-616e033107b4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 23, 2020
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Levalbuterol Inhalation Solution
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code47335-753
Application NumberANDA207820
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levalbuterol Inhalation Solution
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateApril 30, 2020
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LEVALBUTEROL HYDROCHLORIDEActive
Quantity: 1.25 mg in 3 mL
Code: WDQ1526QJM
Classification: ACTIM
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT
Levalbuterol Inhalation Solution
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code47335-743
Application NumberANDA207820
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levalbuterol Inhalation Solution
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateApril 30, 2020
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
LEVALBUTEROL HYDROCHLORIDEActive
Quantity: 0.31 mg in 3 mL
Code: WDQ1526QJM
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
Levalbuterol Inhalation Solution
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code47335-746
Application NumberANDA207820
Product Classification
M
Marketing Category
C73584
G
Generic Name
Levalbuterol Inhalation Solution
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateApril 30, 2020
FDA Product Classification
INGREDIENTS (6)
LEVALBUTEROL HYDROCHLORIDEActive
Quantity: 0.63 mg in 3 mL
Code: WDQ1526QJM
Classification: ACTIM
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT