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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No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

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-db8fbb87beae2026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1664328

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
0fdd0255-0055-65f3-b2c0-db8fbb87beaeempagliflozin 5 MG / metformin hydrochloride 1000 MG Oral Tablet [Synjardy]SBD22These 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
0fdd0255-0055-65f3-b2c0-db8fbb87beaeSynjardy 5 MG / 1000 MG Oral TabletPSN22These 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
0fdd0255-0055-65f3-b2c0-db8fbb87beaeSynjardy (empagliflozin 5 MG / metformin hydrochloride 1000 MG) Oral TabletSY22These 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