FDA.reportPublic FDA data

alogliptin 12.5 MG / metFORMIN HCl 500 MG Oral Tablet

RxCUI
1368392
RxNorm name
alogliptin 12.5 MG / metFORMIN HCl 500 MG Oral Tablet
Display name
alogliptin 12.5 MG / metFORMIN HCl 500 MG Oral Tablet
Full name
alogliptin 12.5 MG / metFORMIN HCl 500 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:06

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
alogliptin and metformin hydrochlorideALOGLIPTIN AND METFORMIN HYDROCHLORIDEPadagis Israel Pharmaceuticals Ltd14d98490-4f8f-4d2f-a4e9-7a3d7a0199ba2026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1368392
KAZANOALOGLIPTIN AND METFORMIN HYDROCHLORIDETakeda Pharmaceuticals America, Inc.83cb7914-a683-47bb-a713-f2bc6a596bd22026-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1368392

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 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
83cb7914-a683-47bb-a713-f2bc6a596bd2alogliptin 12.5 MG / metFORMIN HCl 500 MG Oral Tablet [PSN] · alogliptin 12.5 MG / metformin hydrochloride 500 MG Oral Tablet [SCD] · alogliptin 12.5 MG (as alogliptin benzoate 17 MG / metformin hydrochloride 500 MG) Oral Tablet [SY]321These highlights do not include all the information needed to use KAZANO ® safely and effectively. See full prescribing information for KAZANO. KAZANO (alogliptin and metformin hydrochloride) tablets, for oral use Initial U.S. Approval: 201320250530
14d98490-4f8f-4d2f-a4e9-7a3d7a0199baalogliptin 12.5 MG / metFORMIN HCl 500 MG Oral Tablet [PSN] · alogliptin 12.5 MG / metformin hydrochloride 500 MG Oral Tablet [SCD] · alogliptin 12.5 MG (as alogliptin benzoate 17 MG / metformin hydrochloride 500 MG) Oral Tablet [SY]318These highlights do not include all the information needed to use ALOGLIPTIN AND METFORMIN HCl TABLETS safely and effectively. See full prescribing information for ALOGLIPTIN AND METFORMIN HCl TABLETS. Alogliptin and Metformin Hydrochloride Tablets, for oral use Initial U.S. Approval: 201320250411