FDA.reportPublic FDA data

Janumet 50 mg/1000 mg Oral Tablet

RxCUI
861771
RxNorm name
Janumet 50 mg/1000 mg Oral Tablet
Display name
Janumet 50 mg/1000 mg Oral Tablet
Full name
Janumet 50 mg/1000 mg Oral Tablet
Term type
SY
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JANUMETSITAGLIPTIN AND METFORMIN HYDROCHLORIDEA-S Medication Solutionsc603b844-2019-4ef4-8385-7bc3f96a25652026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861771
JANUMETSITAGLIPTIN AND METFORMIN HYDROCHLORIDEMerck Sharp & Dohme LLCd19c7ed0-ad5c-426e-b2df-722508f97d672025-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 861771

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
d19c7ed0-ad5c-426e-b2df-722508f97d67Janumet 50 MG / 1000 MG Oral Tablet [PSN] · metformin hydrochloride 1000 MG / sitagliptin phosphate 50 MG Oral Tablet [Janumet] [SBD] · Janumet 50 mg/1000 mg Oral Tablet [SY] · Janumet 50/1000 (sitagliptin phosphate 64.25 MG / metformin hydrochloride) Oral Tablet [SY]460These 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
c603b844-2019-4ef4-8385-7bc3f96a2565Janumet 50 MG / 1000 MG Oral Tablet [PSN] · metformin hydrochloride 1000 MG / sitagliptin phosphate 50 MG Oral Tablet [Janumet] [SBD] · Janumet 50 mg/1000 mg Oral Tablet [SY] · Janumet 50/1000 (sitagliptin phosphate 64.25 MG / metformin hydrochloride) Oral Tablet [SY]49These 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: 200720230720