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 AEROSOLInitial U.S. Approval: 1981
Approved
Approval ID
ee6a0830-d5b2-41f7-8451-3d449d8f292e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 6, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-4138
Application NumberNDA021457
Product Classification
M
Marketing Category
C73605
G
Generic Name
Albuterol Sulfate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJanuary 31, 2023
FDA Product Classification
INGREDIENTS (3)
ALBUTEROL SULFATEActive
Quantity: 90 ug in 1 1
Code: 021SEF3731
Classification: ACTIM
NORFLURANEInactive
Code: DH9E53K1Y8
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT