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 Initial U.S. Approval: 1981
Approved
Approval ID
6dc143e7-6bab-42c8-b3e9-9d604d202e73
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2023
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
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 Code63187-026
Application NumberNDA020983
Product Classification
M
Marketing Category
C73594
G
Generic Name
albuterol sulfate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateOctober 1, 2023
FDA Product Classification
INGREDIENTS (2)
ALBUTEROL SULFATEActive
Quantity: 90 ug in 1 1
Code: 021SEF3731
Classification: ACTIM
NORFLURANEInactive
Code: DH9E53K1Y8
Classification: IACT