Albuterol Sulfate Inhalation Solution
Albuterol Sulfate Inhalation Solution 0.63 mg/3 mL and 1.25 mg/3 mL
Approved
Approval ID
d4c532be-1f41-60d3-e053-2995a90a98be
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2023
Manufacturers
FDA
Ritedose Pharmaceuticals, LLC
DUNS: 968062294
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Albuterol Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76204-011
Application NumberANDA214531
Product Classification
M
Marketing Category
C73584
G
Generic Name
Albuterol Sulfate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateDecember 20, 2023
FDA Product Classification
INGREDIENTS (4)
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
ALBUTEROL SULFATEActive
Quantity: 1.25 mg in 3 mL
Code: 021SEF3731
Classification: ACTIM
Albuterol Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76204-010
Application NumberANDA214531
Product Classification
M
Marketing Category
C73584
G
Generic Name
Albuterol Sulfate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateDecember 20, 2023
FDA Product Classification
INGREDIENTS (4)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
ALBUTEROL SULFATEActive
Quantity: 0.63 mg in 3 mL
Code: 021SEF3731
Classification: ACTIM