FDA.reportPublic FDA data

metformin hydrochloride 500 MG / sitagliptin phosphate 50 MG Oral Tablet

RxCUI
2709491
RxNorm name
metformin hydrochloride 500 MG / sitagliptin phosphate 50 MG Oral Tablet
Display name
metformin hydrochloride 500 MG / sitagliptin phosphate 50 MG Oral Tablet
Full name
metformin hydrochloride 500 MG / sitagliptin phosphate 50 MG Oral Tablet
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:22

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#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JANUMETSITAGLIPTIN AND METFORMIN HYDROCHLORIDEA-S Medication Solutionsb55ee3d9-7f0b-4dd9-9213-fbc69f09f5672026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2709491
Sitagliptin and Metformin HydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEApotex Corp.950613e2-e959-6b57-e172-251ddc53c64c2026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2709491
Sitagliptin and Metformin HydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDESandoz Inca0fcdc08-0afc-4912-a126-3efea6bc8c612025-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2709491
JANUMETSITAGLIPTIN AND METFORMIN HYDROCHLORIDEMerck Sharp & Dohme LLCd19c7ed0-ad5c-426e-b2df-722508f97d672025-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2709491

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 4 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
d19c7ed0-ad5c-426e-b2df-722508f97d67metFORMIN hydrochloride 500 MG / SITagliptin phosphate 50 MG Oral Tablet [PSN] · metformin hydrochloride 500 MG / sitagliptin phosphate 50 MG Oral Tablet [SCD]260These highlights do not include all the information needed to use JANUMET safely and effectively. See full prescribing information for JANUMET. JANUMET ® (sitagliptin and metformin hydrochloride) tablets, for oral use Initial U.S. Approval: 200720250325
b55ee3d9-7f0b-4dd9-9213-fbc69f09f567metFORMIN hydrochloride 500 MG / SITagliptin phosphate 50 MG Oral Tablet [PSN] · metformin hydrochloride 500 MG / sitagliptin phosphate 50 MG Oral Tablet [SCD]211These highlights do not include all the information needed to use JANUMET safely and effectively. See full prescribing information for JANUMET. JANUMET ® (sitagliptin and metformin hydrochloride) tablets, for oral use Initial U.S. Approval: 200720230724
950613e2-e959-6b57-e172-251ddc53c64cmetFORMIN hydrochloride 500 MG / SITagliptin phosphate 50 MG Oral Tablet [PSN] · metformin hydrochloride 500 MG / sitagliptin phosphate 50 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use SITAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SITAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLETS. SITAGLIPTIN AND METFORMIN HYDROCHLORIDE tablets for oral use. Initial U.S. Approval: 200720260414
a0fcdc08-0afc-4912-a126-3efea6bc8c61metFORMIN hydrochloride 500 MG / SITagliptin phosphate 50 MG Oral Tablet [PSN] · metformin hydrochloride 500 MG / sitagliptin phosphate 50 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use SITAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for SITAGLIPTIN AND METFORMIN HYDROCHLORIDE TABLETS. SITAGLIPTIN and METFORMIN HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 200720250901