Proventil HFA
PROVENTIL HFA (albuterol sulfate) Inhalation Aerosol with Dose Indicator
Approved
Approval ID
917b6148-61f2-4e4d-9560-d261bac97060
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 14, 2023
Manufacturers
FDA
Sandoz
DUNS: 005387188
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 Code66758-959
Application NumberNDA020503
Product Classification
M
Marketing Category
C73594
G
Generic Name
Albuterol Sulfate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJune 14, 2023
FDA Product Classification
INGREDIENTS (4)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
NORFLURANEInactive
Code: DH9E53K1Y8
Classification: IACT
OLEIC ACIDInactive
Code: 2UMI9U37CP
Classification: IACT
ALBUTEROL SULFATEActive
Quantity: 108 ug in 1 1
Code: 021SEF3731
Classification: ACTIM