Proventil HFA
PROVENTIL® HFA(albuterol sulfate)Inhalation Aerosol
Approved
Approval ID
1c16cecd-8e1d-43b2-87e9-6d79a81c26a1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 13, 2019
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-4326
Application NumberNDA020503
Product Classification
M
Marketing Category
C73594
G
Generic Name
Albuterol Sulfate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateOctober 12, 2016
FDA Product Classification
INGREDIENTS (4)
ALBUTEROL SULFATEActive
Quantity: 108 ug in 1 1
Code: 021SEF3731
Classification: ACTIM
alcoholInactive
Code: 3K9958V90M
Classification: IACT
NORFLURANEInactive
Code: DH9E53K1Y8
Classification: IACT
Oleic acidInactive
Code: 2UMI9U37CP
Classification: IACT