Trijardy XR
These highlights do not include all the information needed to use TRIJARDY XR safely and effectively. See full prescribing information for TRIJARDY XR. TRIJARDY XR (empagliflozin, linagliptin, and metformin hydrochloride extended-release tablets), for oral use Initial U.S. Approval: 2020
Approved
Approval ID
71873567-9594-452a-bb92-34a129adecac
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 7, 2023
Manufacturers
FDA
Boehringer Ingelheim Pharmaceuticals, Inc.
DUNS: 603175944
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
empagliflozin, linagliptin, metformin hydrochloride
PRODUCT DETAILS
NDC Product Code0597-0385
Application NumberNDA212614
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateOctober 31, 2023
Generic Nameempagliflozin, linagliptin, metformin hydrochloride
INGREDIENTS (3)
EMPAGLIFLOZINActive
Quantity: 12.5 mg in 1 1
Code: HDC1R2M35U
Classification: ACTIB
LINAGLIPTINActive
Quantity: 2.5 mg in 1 1
Code: 3X29ZEJ4R2
Classification: ACTIB
METFORMIN HYDROCHLORIDEActive
Quantity: 1000 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
empagliflozin, linagliptin, metformin hydrochloride
PRODUCT DETAILS
NDC Product Code0597-0395
Application NumberNDA212614
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateOctober 31, 2023
Generic Nameempagliflozin, linagliptin, metformin hydrochloride
INGREDIENTS (3)
EMPAGLIFLOZINActive
Quantity: 5 mg in 1 1
Code: HDC1R2M35U
Classification: ACTIB
LINAGLIPTINActive
Quantity: 2.5 mg in 1 1
Code: 3X29ZEJ4R2
Classification: ACTIB
METFORMIN HYDROCHLORIDEActive
Quantity: 1000 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
empagliflozin, linagliptin, metformin hydrochloride
PRODUCT DETAILS
NDC Product Code0597-0380
Application NumberNDA212614
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateOctober 31, 2023
Generic Nameempagliflozin, linagliptin, metformin hydrochloride
INGREDIENTS (3)
EMPAGLIFLOZINActive
Quantity: 10 mg in 1 1
Code: HDC1R2M35U
Classification: ACTIB
LINAGLIPTINActive
Quantity: 5 mg in 1 1
Code: 3X29ZEJ4R2
Classification: ACTIB
METFORMIN HYDROCHLORIDEActive
Quantity: 1000 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
empagliflozin, linagliptin, metformin hydrochloride
PRODUCT DETAILS
NDC Product Code0597-0390
Application NumberNDA212614
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateOctober 31, 2023
Generic Nameempagliflozin, linagliptin, metformin hydrochloride
INGREDIENTS (3)
METFORMIN HYDROCHLORIDEActive
Quantity: 1000 mg in 1 1
Code: 786Z46389E
Classification: ACTIB
LINAGLIPTINActive
Quantity: 5 mg in 1 1
Code: 3X29ZEJ4R2
Classification: ACTIB
EMPAGLIFLOZINActive
Quantity: 25 mg in 1 1
Code: HDC1R2M35U
Classification: ACTIB