FDA.reportPublic FDA data

empagliflozin 12.5 MG / metformin hydrochloride 1000 MG Oral Tablet

RxCUI
1665367
RxNorm name
empagliflozin 12.5 MG / metformin hydrochloride 1000 MG Oral Tablet
Display name
empagliflozin 12.5 MG / metformin hydrochloride 1000 MG Oral Tablet
Full name
empagliflozin 12.5 MG / metformin hydrochloride 1000 MG Oral Tablet
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:38:47

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 · 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: 1665367

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-db8fbb87beaeempagliflozin 12.5 MG / metFORMIN HCl 1000 MG Oral Tablet [PSN] · empagliflozin 12.5 MG / metformin hydrochloride 1000 MG Oral Tablet [SCD]222These 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