FDA.reportPublic FDA data

linagliptin 2.5 MG / metformin hydrochloride 850 MG Oral Tablet

RxCUI
1243034
RxNorm name
linagliptin 2.5 MG / metformin hydrochloride 850 MG Oral Tablet
Display name
linagliptin 2.5 MG / metformin hydrochloride 850 MG Oral Tablet
Full name
linagliptin 2.5 MG / metformin hydrochloride 850 MG Oral Tablet
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:28

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Linagliptin and metformin hydrochlorideLINAGLIPTIN AND METFORMIN HYDROCHLORIDENovadoz Pharmaceuticals LLC5cff87ef-97f9-4e3c-9e06-fd257f3cb3fb2025-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1243034
JentaduetoLINAGLIPTIN AND METFORMIN HYDROCHLORIDEBoehringer Ingelheim Pharmaceuticals, Inc.f6dd9b86-0d18-95d4-2bc7-05591bfdd5972024-06-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1243034

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
f6dd9b86-0d18-95d4-2bc7-05591bfdd597linagliptin 2.5 MG / metformin hydrochloride 850 MG Oral TabletSCD45These highlights do not include all the information needed to use JENTADUETO safely and effectively. See full prescribing information for JENTADUETO. JENTADUETO ® (linagliptin and metformin hydrochloride tablets), for oral use Initial U.S. Approval: 201220240627
f6dd9b86-0d18-95d4-2bc7-05591bfdd597linagliptin 2.5 MG / metFORMIN HCl 850 MG Oral TabletPSN45These highlights do not include all the information needed to use JENTADUETO safely and effectively. See full prescribing information for JENTADUETO. JENTADUETO ® (linagliptin and metformin hydrochloride tablets), for oral use Initial U.S. Approval: 201220240627
5cff87ef-97f9-4e3c-9e06-fd257f3cb3fblinagliptin 2.5 MG / metFORMIN HCl 850 MG Oral TabletPSN1These highlights do not include all the information needed to use LINAGLIPTIN and METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for LINAGLIPTIN and METFORMIN HYDROCHLORIDE TABLETS. LINAGLIPTIN and METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 201220251104
5cff87ef-97f9-4e3c-9e06-fd257f3cb3fblinagliptin 2.5 MG / metformin hydrochloride 850 MG Oral TabletSCD1These highlights do not include all the information needed to use LINAGLIPTIN and METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for LINAGLIPTIN and METFORMIN HYDROCHLORIDE TABLETS. LINAGLIPTIN and METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 201220251104