VENTOLIN
These highlights do not include all the information needed to use VENTOLIN HFA safely and effectively. See full prescribing information for VENTOLIN HFA.VENTOLIN HFA (albuterol sulfate) Inhalation Aerosol FOR ORAL INHALATIONInitial U.S. Approval: 1981
Approved
Approval ID
01ac31ac-a9e2-4528-b4a4-89b17c59a2c9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2020
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53002-1584
Application NumberNDA020983
Product Classification
M
Marketing Category
C73594
G
Generic Name
albuterol sulfate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateDecember 19, 2014
FDA Product Classification
INGREDIENTS (2)
ALBUTEROL SULFATEActive
Quantity: 90 ug in 1 1
Code: 021SEF3731
Classification: ACTIM
NORFLURANEInactive
Code: DH9E53K1Y8
Classification: IACT