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
faf3dd6a-9cd0-39c2-0d2e-232cb3f67565
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 21, 2023
Manufacturers
FDA
Boehringer Ingelheim Pharmaceuticals, Inc.
DUNS: 603175944
Products 2
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 Code0597-0153
Application NumberNDA204629
Product Classification
M
Marketing Category
C73594
G
Generic Name
Empagliflozin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 21, 2023
FDA Product Classification
INGREDIENTS (1)
EMPAGLIFLOZINActive
Quantity: 25 mg in 1 1
Code: HDC1R2M35U
Classification: ACTIB
Empagliflozin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0597-0152
Application NumberNDA204629
Product Classification
M
Marketing Category
C73594
G
Generic Name
Empagliflozin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 21, 2023
FDA Product Classification
INGREDIENTS (1)
EMPAGLIFLOZINActive
Quantity: 10 mg in 1 1
Code: HDC1R2M35U
Classification: ACTIB