FDA.reportPublic FDA data

metformin hydrochloride 1000 MG / sitagliptin phosphate 50 MG 24 HR Extended Release Oral Tablet

RxCUI
2709477
RxNorm name
metformin hydrochloride 1000 MG / sitagliptin phosphate 50 MG 24 HR Extended Release Oral Tablet
Display name
metformin hydrochloride 1000 MG / sitagliptin phosphate 50 MG 24 HR Extended Release Oral Tablet
Full name
metformin hydrochloride 1000 MG / sitagliptin phosphate 50 MG 24 HR Extended Release Oral Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:01

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sitagliptin and Metformin hydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEPar Health USA, LLC43e3b1c9-3cbd-8dc3-e063-6394a90a10a22025-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2709477
JANUMET XRSITAGLIPTIN AND METFORMIN HYDROCHLORIDEMerck Sharp & Dohme LLC64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b502025-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2709477
JANUMET XRSITAGLIPTIN AND METFORMIN HYDROCHLORIDEA-S Medication Solutions90c0244b-afb3-4e69-b79f-486d002ca4322023-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2709477

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 3 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50metFORMIN hydrochloride 1000 MG / SITagliptin phosphate 50 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR metformin hydrochloride 1000 MG / sitagliptin phosphate 50 MG Extended Release Oral Tablet [SCD] · metformin hydrochloride 1000 MG / sitagliptin phosphate 50 MG 24 HR Extended Release Oral Tablet [SY]343These highlights do not include all the information needed to use JANUMET XR safely and effectively. See full prescribing information for JANUMET XR. JANUMET ® XR (sitagliptin and metformin hydrochloride extended-release) tablets, for oral use Initial U.S. Approval: 201220250325
90c0244b-afb3-4e69-b79f-486d002ca432metFORMIN hydrochloride 1000 MG / SITagliptin phosphate 50 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR metformin hydrochloride 1000 MG / sitagliptin phosphate 50 MG Extended Release Oral Tablet [SCD] · metformin hydrochloride 1000 MG / sitagliptin phosphate 50 MG 24 HR Extended Release Oral Tablet [SY]37These highlights do not include all the information needed to use JANUMET XR safely and effectively. See full prescribing information for JANUMET XR. JANUMET ® XR (sitagliptin and metformin hydrochloride extended-release) tablets, for oral use Initial U.S. Approval: 201220230616
6d1c5225-a457-438c-93fa-15697db02363metFORMIN hydrochloride 1000 MG / SITagliptin phosphate 50 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR metformin hydrochloride 1000 MG / sitagliptin phosphate 50 MG Extended Release Oral Tablet [SCD] · metformin hydrochloride 1000 MG / sitagliptin phosphate 50 MG 24 HR Extended Release Oral Tablet [SY]34These highlights do not include all the information needed to use JANUMET XR safely and effectively. See full prescribing information for JANUMET XR. JANUMET ® XR (sitagliptin and metformin hydrochloride extended-release) tablets, for oral use Initial U.S. Approval: 201220210204