Jentadueto XR
These highlights do not include all the information needed to use JENTADUETO XR safely and effectively. See full prescribing information for JENTADUETO XR. JENTADUETO XR (linagliptin and metformin hydrochloride extended-release tablets), for oral use Initial U.S. Approval: 2012
Approved
Approval ID
3d02a4d4-d312-80b4-05c4-691b8f0aa7aa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 26, 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.
linagliptin and metformin hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0597-0270
Application NumberNDA208026
Product Classification
M
Marketing Category
C73594
G
Generic Name
linagliptin and metformin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 26, 2023
FDA Product Classification
INGREDIENTS (2)
LINAGLIPTINActive
Quantity: 2.5 mg in 1 1
Code: 3X29ZEJ4R2
Classification: ACTIB
METFORMIN HYDROCHLORIDEActive
Quantity: 1000 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
linagliptin and metformin hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0597-0275
Application NumberNDA208026
Product Classification
M
Marketing Category
C73594
G
Generic Name
linagliptin and metformin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 26, 2023
FDA Product Classification
INGREDIENTS (2)
METFORMIN HYDROCHLORIDEActive
Quantity: 1000 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
LINAGLIPTINActive
Quantity: 5 mg in 1 1
Code: 3X29ZEJ4R2
Classification: ACTIB