PROAIR
These highlights do not include all the information needed to use PROAIR HFA safely and effectively. See full prescribing information for PROAIR HFA Inhalation Aerosol. PROAIR HFA (albuterol sulfate) INHALATION AEROSOL Initial U.S. Approval: 1981
Approved
Approval ID
133fb50a-68d3-4d1b-a47a-67d07cc48da5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 11, 2010
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 Code21695-851
Application NumberNDA021457
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 (3)
ALBUTEROL SULFATEActive
Quantity: 90 ug in 1 1
Code: 021SEF3731
Classification: ACTIM
NORFLURANEInactive
Code: DH9E53K1Y8
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT