Albuterol Sulfate
Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL (RDP)
Approved
Approval ID
19867b61-77a2-46f1-97c7-7fadfec5882b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 4, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-0516
Application NumberANDA077839
Product Classification
M
Marketing Category
C73584
G
Generic Name
Albuterol Sulfate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateDecember 19, 2022
FDA Product Classification
INGREDIENTS (1)
ALBUTEROL SULFATEActive
Quantity: 2.5 mg in 3 mL
Code: 021SEF3731
Classification: ACTIM