VENTOLINHFA
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
b1a801d6-9573-4997-9b4a-aec6db6459ed
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 1, 2009
Manufacturers
FDA
Rebel Distributors Corp.
DUNS: 118802834
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 Code21695-423
Application NumberNDA020983
Product Classification
M
Marketing Category
C73594
G
Generic Name
albuterol sulfate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateSeptember 1, 2009
FDA Product Classification
INGREDIENTS (2)
ALBUTEROL SULFATEActive
Quantity: 108 ug in 1 1
Code: 021SEF3731
Classification: ACTIB
NORFLURANEInactive
Code: DH9E53K1Y8
Classification: IACT