VENTOLIN
These highlights do not include all the information needed to use VENTOLIN HFA Inhalation Aerosol safely and effectively. See full prescribing information for VENTOLIN HFA Inhalation Aerosol.VENTOLIN HFA (albuterol sulfate) Inhalation Aerosol Initial U.S. Approval: 1981
Approved
Approval ID
77f24a8c-0a9a-4708-a401-3f56b5d4f2c1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 20, 2012
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
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 Code52959-983
Application NumberNDA020983
Product Classification
M
Marketing Category
C73594
G
Generic Name
albuterol sulfate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJanuary 20, 2012
FDA Product Classification
INGREDIENTS (2)
ALBUTEROL SULFATEActive
Quantity: 108 ug in 1 1
Code: 021SEF3731
Classification: ACTIB
NORFLURANEInactive
Code: DH9E53K1Y8
Classification: IACT