FDA.reportPublic FDA data

metformin hydrochloride 1000 MG / saxagliptin (as saxagliptin hydrochloride) 2.5 MG 24 HR Extended Release Oral Tablet

RxCUI
1043563
RxNorm name
metformin hydrochloride 1000 MG / saxagliptin (as saxagliptin hydrochloride) 2.5 MG 24 HR Extended Release Oral Tablet
Display name
metformin hydrochloride 1000 MG / saxagliptin (as saxagliptin hydrochloride) 2.5 MG 24 HR Extended Release Oral Tablet
Full name
metformin hydrochloride 1000 MG / saxagliptin (as saxagliptin hydrochloride) 2.5 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Saxagliptin and MetforminSAXAGLIPTIN AND METFORMINMylan Pharmaceuticals Inc.cbf8677c-cafe-48bc-8844-0cc6547886bd2026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1043563
Saxagliptin and Metformin HydrochlorideSAXAGLIPTIN AND METFORMIN HYDROCHLORIDEDr.Reddys Laboratories Inc65884427-4dde-63bb-a23f-36a7779c0a6b2026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1043563

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
65884427-4dde-63bb-a23f-36a7779c0a6bmetformin hydrochloride 1000 MG / saxagliptin (as saxagliptin hydrochloride) 2.5 MG 24 HR Extended Release Oral TabletSY7These highlights do not include all the information needed to use SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. SAXAGLIPTIN and METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 201020260410
65884427-4dde-63bb-a23f-36a7779c0a6bsAXagliptin 2.5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral TabletPSN7These highlights do not include all the information needed to use SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. SAXAGLIPTIN and METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 201020260410
65884427-4dde-63bb-a23f-36a7779c0a6b24 HR metformin hydrochloride 1000 MG / saxagliptin 2.5 MG Extended Release Oral TabletSCD7These highlights do not include all the information needed to use SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. SAXAGLIPTIN and METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 201020260410
cbf8677c-cafe-48bc-8844-0cc6547886bdsAXagliptin 2.5 MG / metFORMIN HCl 1000 MG 24HR Extended Release Oral TabletPSN6These highlights do not include all the information needed to use SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS . SAXAGLIPTIN and METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 201020260406
cbf8677c-cafe-48bc-8844-0cc6547886bdmetformin hydrochloride 1000 MG / saxagliptin (as saxagliptin hydrochloride) 2.5 MG 24 HR Extended Release Oral TabletSY6These highlights do not include all the information needed to use SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS . SAXAGLIPTIN and METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 201020260406
cbf8677c-cafe-48bc-8844-0cc6547886bd24 HR metformin hydrochloride 1000 MG / saxagliptin 2.5 MG Extended Release Oral TabletSCD6These highlights do not include all the information needed to use SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS . SAXAGLIPTIN and METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 201020260406