albuterol sulfate
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 1981
Approved
Approval ID
489201d2-9ed0-419b-81dc-a7f7f86b59ed
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2021
Manufacturers
FDA
Padagis Israel Pharmaceuticals Ltd
DUNS: 600093611
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 Code45802-088
Application NumberANDA203760
Product Classification
M
Marketing Category
C73584
G
Generic Name
albuterol sulfate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateDecember 1, 2021
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