FDA.reportPublic FDA data

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

RxCUI
1243842
RxNorm name
24 HR metformin hydrochloride 1000 MG / sitagliptin 50 MG Extended Release Oral Tablet
Display name
24 HR metformin hydrochloride 1000 MG / sitagliptin 50 MG Extended Release Oral Tablet
Full name
24 HR metformin hydrochloride 1000 MG / sitagliptin 50 MG Extended Release 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
ZITUVIMET XRSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Lifesciences Limited4bade493-499e-434a-97a0-26ca689176232026-01-05Exact identifier
rxcui: 1243842
ZITUVIMET XRSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Pharmaceuticals USA Inc.2f635b36-e86a-4e53-8eaf-589917b5f3422025-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1243842
Sitagliptin and Metformin HydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Pharmaceuticals USA Inc.d3a728a0-decb-4340-8ee4-c5e27c13eb192024-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1243842
Sitagliptin and Metformin HydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Lifesciences Limiteda07fa1d9-7171-4f2a-ab34-f8fa410364a62024-08-24Exact identifier
rxcui: 1243842

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
4bade493-499e-434a-97a0-26ca68917623SITagliptin 50 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR metformin hydrochloride 1000 MG / sitagliptin 50 MG Extended Release Oral Tablet [SCD] · metformin hydrochloride 1000 MG / sitagliptin 50 MG 24 HR Extended Release Oral Tablet [SY]32ZITUVIMET® XR (sitagliptin and metformin hydrochloride) extended-release tablets, for oral use20260105
2f635b36-e86a-4e53-8eaf-589917b5f342SITagliptin 50 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR metformin hydrochloride 1000 MG / sitagliptin 50 MG Extended Release Oral Tablet [SCD] · metformin hydrochloride 1000 MG / sitagliptin 50 MG 24 HR Extended Release Oral Tablet [SY]32These highlights do not include all the information needed to use ZITUVIMET ® XR safely and effectively. See full prescribing information for ZITUVIMET ® XR. ZITUVIMET ® XR (sitagliptin and metformin hydrochloride) extended-release tablets, for oral use Initial U.S. Approval: 200720250716
d3a728a0-decb-4340-8ee4-c5e27c13eb19SITagliptin 50 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR metformin hydrochloride 1000 MG / sitagliptin 50 MG Extended Release Oral Tablet [SCD] · metformin hydrochloride 1000 MG / sitagliptin 50 MG 24 HR Extended Release Oral Tablet [SY]32These highlights do not include all the information needed to use SITAGLIPTIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for SITAGLIPTIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. SITAGLIPTIN AND METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 200720240831
a07fa1d9-7171-4f2a-ab34-f8fa410364a6SITagliptin 50 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR metformin hydrochloride 1000 MG / sitagliptin 50 MG Extended Release Oral Tablet [SCD] · metformin hydrochloride 1000 MG / sitagliptin 50 MG 24 HR Extended Release Oral Tablet [SY]31Sitagliptin and Metformin Hydrochloride Extended-Release Tablets, for oral use20240824