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
NDC Product Code76420-350
Application NumberANDA209954
Marketing CategoryC73584
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateMay 7, 2025
Generic NameAlbuterol sulfate
INGREDIENTS (3)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
NORFLURANEInactive
Code: DH9E53K1Y8
Classification: IACT
ALBUTEROL SULFATEActive
Quantity: 90 ug in 1 1
Code: 021SEF3731
Classification: ACTIM