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
9f8a6b17-f051-43f8-93a3-10b44b745b7f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2024
Manufacturers
FDA
RPK Pharmaceuticals, Inc.
DUNS: 147096275
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 Code53002-1554
Application NumberANDA209954
Marketing CategoryC73584
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateDecember 1, 2022
Generic NameAlbuterol sulfate
INGREDIENTS (3)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ALBUTEROL SULFATEActive
Quantity: 90 ug in 1 1
Code: 021SEF3731
Classification: ACTIM
NORFLURANEInactive
Code: DH9E53K1Y8
Classification: IACT