Albuterol sulfate
These highlights do not include all the information needed to use ALBUTEROL SULFATE INHALATION AEROSOL safely and effectively. See full prescribing information for ALBUTEROL SULFATE INHALATION AEROSOL. ALBUTEROL SULFATE inhalation aerosol, for oral use. Initial U.S. Approval: 1981
Approved
Approval ID
264e2145-c7d4-4f4f-aa5b-9fe48a7c5b47
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 7, 2025
Manufacturers
FDA
Asclemed USA, Inc.
DUNS: 059888437
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 Code76420-350
Application NumberANDA209954
Product Classification
M
Marketing Category
C73584
G
Generic Name
Albuterol sulfate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateMay 7, 2025
FDA Product Classification
INGREDIENTS (3)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
NORFLURANEInactive
Code: DH9E53K1Y8
Classification: IACT
ALBUTEROL SULFATEActive
Quantity: 90 ug in 1 1
Code: 021SEF3731
Classification: ACTIM