Albuterol Sulfate
These highlights do not include all the information needed to use Albuterol Sulfate HFA safely and effectively. See full prescribing information for Albuterol Sulfate HFA Inhalation Aerosol ALBUTEROL SULFATE HFA INHALATION AEROSOL Initial U.S. Approval: 1981
Approved
Approval ID
a69489f7-4ffb-4cd1-b2d2-002f48e84f51
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 19, 2023
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 Code76420-088
Application NumberNDA021457
Product Classification
M
Marketing Category
C73594
G
Generic Name
Albuterol Sulfate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateDecember 19, 2023
FDA Product Classification
INGREDIENTS (3)
NORFLURANEInactive
Code: DH9E53K1Y8
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ALBUTEROL SULFATEActive
Quantity: 90 ug in 1 1
Code: 021SEF3731
Classification: ACTIM