JARDIANCE
These highlights do not include all the information needed to use JARDIANCE safely and effectively. See full prescribing information for JARDIANCE. JARDIANCE (empagliflozin tablets), for oral useInitial U.S. Approval: 2014
Approved
Approval ID
f2b41c77-0abb-40ee-8578-86a748d0e19e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 3, 2023
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.
Empagliflozin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-6457
Application NumberNDA204629
Product Classification
M
Marketing Category
C73594
G
Generic Name
Empagliflozin
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2021
FDA Product Classification
INGREDIENTS (1)
EMPAGLIFLOZINActive
Quantity: 25 mg in 1 1
Code: HDC1R2M35U
Classification: ACTIB