FDA.reportPublic FDA data

empagliflozin 5 MG / metformin hydrochloride 1000 MG Oral Tablet [Synjardy]

RxCUI
1664328
RxNorm name
empagliflozin 5 MG / metformin hydrochloride 1000 MG Oral Tablet [Synjardy]
Display name
empagliflozin 5 MG / metformin hydrochloride 1000 MG Oral Tablet [Synjardy]
Full name
empagliflozin 5 MG / metformin hydrochloride 1000 MG Oral Tablet [Synjardy]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:47

RxNav Current And Historical NDCs#

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UNII Substances#

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openFDA label cross-check#

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Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SynjardyEMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEBoehringer Ingelheim Pharmaceuticals, Inc.0fdd0255-0055-65f3-b2c0-db8fbb87beae2026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1664328

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 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
0fdd0255-0055-65f3-b2c0-db8fbb87beaeSynjardy 5 MG / 1000 MG Oral Tablet [PSN] · empagliflozin 5 MG / metformin hydrochloride 1000 MG Oral Tablet [Synjardy] [SBD] · Synjardy (empagliflozin 5 MG / metformin hydrochloride 1000 MG) Oral Tablet [SY]322These highlights do not include all the information needed to use SYNJARDY and SYNJARDY XR safely and effectively. See full prescribing information for SYNJARDY and SYNJARDY XR. SYNJARDY ® (empagliflozin and metformin hydrochloride tablets), for oral use SYNJARDY ® XR (empagliflozin and metformin hydrochloride extended-release tablets), for oral use Initial U.S. Approval: 201520260130