Glyxambi
These highlights do not include all the information needed to use GLYXAMBI safely and effectively. See full prescribing information for GLYXAMBI. GLYXAMBI (empagliflozin and linagliptin tablets), for oral use Initial U.S. Approval: 2015
Approved
Approval ID
ddbab689-f76c-488c-9613-4168d41dd730
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 2, 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 and linagliptin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0597-0182
Application NumberNDA206073
Product Classification
M
Marketing Category
C73594
G
Generic Name
empagliflozin and linagliptin
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2023
FDA Product Classification
INGREDIENTS (2)
EMPAGLIFLOZINActive
Quantity: 10 mg in 1 1
Code: HDC1R2M35U
Classification: ACTIB
LINAGLIPTINActive
Quantity: 5 mg in 1 1
Code: 3X29ZEJ4R2
Classification: ACTIB
empagliflozin and linagliptin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0597-0164
Application NumberNDA206073
Product Classification
M
Marketing Category
C73594
G
Generic Name
empagliflozin and linagliptin
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2023
FDA Product Classification
INGREDIENTS (2)
EMPAGLIFLOZINActive
Quantity: 25 mg in 1 1
Code: HDC1R2M35U
Classification: ACTIB
LINAGLIPTINActive
Quantity: 5 mg in 1 1
Code: 3X29ZEJ4R2
Classification: ACTIB