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
58860ee1-5a9d-4422-b9bc-78e8b7958b53
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 2, 2010
Manufacturers
FDA
Dispensing Solutions Inc.
DUNS: 066070785
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 Code68258-3037
Application NumberNDA020983
Product Classification
M
Marketing Category
C73594
G
Generic Name
albuterol sulfate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateMarch 2, 2010
FDA Product Classification
INGREDIENTS (2)
ALBUTEROL SULFATEActive
Quantity: 108 ug in 1 1
Code: 021SEF3731
Classification: ACTIB
NORFLURANEInactive
Code: DH9E53K1Y8
Classification: IACT