FDA.reportPublic FDA data

Janumet XR 50 MG / 500 MG 24HR Extended Release Oral Tablet

RxCUI
1243848
RxNorm name
Janumet XR 50 MG / 500 MG 24HR Extended Release Oral Tablet
Display name
Janumet XR 50 MG / 500 MG 24HR Extended Release Oral Tablet
Full name
Janumet XR 50 MG / 500 MG 24HR Extended Release Oral Tablet
Term type
PSN
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#

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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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JANUMET XRSITAGLIPTIN AND METFORMIN HYDROCHLORIDEMerck Sharp & Dohme LLC64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b502025-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1243848

DailyMed RxNorm Mappings#

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

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50Janumet XR 50 MG / 500 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR metformin hydrochloride 500 MG / sitagliptin phosphate 50 MG Extended Release Oral Tablet [Janumet] [SBD] · Janumet XR 50/500 (sitagliptin (sitagliptin phosphate monohydrate 64.25 MG) / metformin hydrochloride) 24 HR Extended Release Oral Tablet [SY] · Janumet XR 50/500 (sitagliptin / metformin hydrochloride) 24 HR Extended Release Oral Tablet [SY] · Janumet XR 50/500 24 HR Extended Release Oral Tablet [SY]543These 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