Albuterol Sulfate
Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL (RDP)
Approved
Approval ID
b72742df-1a6b-4483-aff3-3e79db5e015d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2023
Manufacturers
FDA
Ritedose Pharmaceuticals, LLC
DUNS: 968062294
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 Code76204-200
Application NumberANDA077839
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 (1)
ALBUTEROL SULFATEActive
Quantity: 2.5 mg in 3 mL
Code: 021SEF3731
Classification: ACTIM