Albuterol Sulfate
Albuterol Sulfate Inhalation Solution 0.021% & 0.042%
Approved
Approval ID
285a656c-f77f-4e77-b0a8-a0e9c901803f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2021
Manufacturers
FDA
Nephron Pharmaceuticals Corporation
DUNS: 079160190
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 Code0487-9904
Application NumberANDA076355
Product Classification
M
Marketing Category
C73584
G
Generic Name
Albuterol Sulfate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJanuary 11, 2021
FDA Product Classification
INGREDIENTS (4)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
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 Code0487-0301
Application NumberANDA076355
Product Classification
M
Marketing Category
C73584
G
Generic Name
Albuterol Sulfate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJanuary 11, 2021
FDA Product Classification
INGREDIENTS (4)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALBUTEROL SULFATEActive
Quantity: 0.63 mg in 3 mL
Code: 021SEF3731
Classification: ACTIM
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT