FDA.reportPublic FDA data

metformin hydrochloride 1000 MG / sitagliptin 50 MG Oral Tablet

RxCUI
861769
RxNorm name
metformin hydrochloride 1000 MG / sitagliptin 50 MG Oral Tablet
Display name
metformin hydrochloride 1000 MG / sitagliptin 50 MG Oral Tablet
Full name
metformin hydrochloride 1000 MG / sitagliptin 50 MG Oral Tablet
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:27

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
Sitagliptin and metformin hydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.4d812277-21a8-4de3-b728-e3fdd01305b52026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861769
Sitagliptin and metformin hydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Lifesciences Limitede07abcb1-1f0c-4cad-8405-8eedba4b8ff82026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861769
ZITUVIMETSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Lifesciences Limited0098dec4-f0e5-45d5-8aa4-5d0faf9ab1422026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861769
ZITUVIMETSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.eeda90a0-4941-4716-8684-f9f12cbdf3af2026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861769

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
4d812277-21a8-4de3-b728-e3fdd01305b5SITagliptin 50 MG / metFORMIN HCl 1000 MG Oral Tablet [PSN] · metformin hydrochloride 1000 MG / sitagliptin 50 MG Oral Tablet [SCD] · metformin hydrochloride 1000 MG / sitagliptin 50 MG Oral Tablet [SY]36These 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 (sitagliptin and metformin hydrochloride) tablets, for oral use Initial U.S. Approval: 200720250609
e07abcb1-1f0c-4cad-8405-8eedba4b8ff8SITagliptin 50 MG / metFORMIN HCl 1000 MG Oral Tablet [PSN] · metformin hydrochloride 1000 MG / sitagliptin 50 MG Oral Tablet [SCD] · metformin hydrochloride 1000 MG / sitagliptin 50 MG Oral Tablet [SY]36These 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 (sitagliptin and metformin hydrochloride) tablets, for oral use Initial U.S. Approval: 200720250609
eeda90a0-4941-4716-8684-f9f12cbdf3afSITagliptin 50 MG / metFORMIN HCl 1000 MG Oral Tablet [PSN] · metformin hydrochloride 1000 MG / sitagliptin 50 MG Oral Tablet [SCD] · metformin hydrochloride 1000 MG / sitagliptin 50 MG Oral Tablet [SY]36These highlights do not include all the information needed to use ZITUVIMET safely and effectively. See full prescribing information for ZITUVIMET. ZITUVIMET ® (sitagliptin and metformin hydrochloride) tablets, for oral use Initial U.S. Approval: 200720250609
0098dec4-f0e5-45d5-8aa4-5d0faf9ab142SITagliptin 50 MG / metFORMIN HCl 1000 MG Oral Tablet [PSN] · metformin hydrochloride 1000 MG / sitagliptin 50 MG Oral Tablet [SCD] · metformin hydrochloride 1000 MG / sitagliptin 50 MG Oral Tablet [SY]35These highlights do not include all the information needed to use ZITUVIMET safely and effectively. See full prescribing information for ZITUVIMET. ZITUVIMET ® (sitagliptin and metformin hydrochloride) tablets, for oral use Initial U.S. Approval: 200720250609