Albuterol Sulate
These highlights do not include all the information needed to use Albuterol Sulfate HFA safely and effectively. See full prescribing information for Albuterol Sulfate HFA. Albuterol Sulfate HFA Inhalation Aerosol FOR ORAL INHALATION Initial U.S. Approval: 1981
Approved
Approval ID
825975b1-a4a9-78ca-e053-2a91aa0a3948
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 17, 2021
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 Code68071-4777
Application NumberNDA020983
Product Classification
M
Marketing Category
C73605
G
Generic Name
albuterol sulfate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateFebruary 17, 2021
FDA Product Classification
INGREDIENTS (2)
NORFLURANEInactive
Code: DH9E53K1Y8
Classification: IACT
ALBUTEROL SULFATEActive
Quantity: 90 ug in 1 1
Code: 021SEF3731
Classification: ACTIM