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
55f4153f-4eed-6565-e054-00144ff88e88
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 15, 2020
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
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 Code68071-1525
Application NumberNDA021457
Product Classification
M
Marketing Category
C73594
G
Generic Name
Albuterol Sulfate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJune 15, 2020
FDA Product Classification
INGREDIENTS (3)
NORFLURANEInactive
Code: DH9E53K1Y8
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ALBUTEROL SULFATEActive
Quantity: 90 ug in 1 1
Code: 021SEF3731
Classification: ACTIM