Albuterol Sulfate
Albuterol Sulfate Inhalation Solution 0.083%* (*Potency expressed as albuterol, equivalent to 3 mg albuterol sulfate) Rx only
Approved
Approval ID
6ec88f64-66a2-4ca9-9913-c192fc33f88b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 19, 2024
Manufacturers
FDA
Cardinal Health 107, LLC
DUNS: 118546603
Products 1
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 Code55154-2132
Application NumberANDA077839
Product Classification
M
Marketing Category
C73584
G
Generic Name
Albuterol Sulfate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateFebruary 3, 2023
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: 2.5 mg in 3 mL
Code: 021SEF3731
Classification: ACTIM