FDA.reportPublic FDA data

24 HR empagliflozin 25 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Synjardy]

RxCUI
1862697
RxNorm name
24 HR empagliflozin 25 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Synjardy]
Display name
24 HR empagliflozin 25 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Synjardy]
Full name
24 HR empagliflozin 25 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Synjardy]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:05

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
Synjardy XREMPAGLIFLOZIN, METFORMIN HYDROCHLORIDEBoehringer Ingelheim Pharmaceuticals, Inc.8006ba29-ee3a-f852-a9bb-c8ec9b41cf662026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1862697

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
8006ba29-ee3a-f852-a9bb-c8ec9b41cf66Synjardy XR 25 MG / 1000 MG 24HR Extended Release Oral Tablet [PSN] · 24 HR empagliflozin 25 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Synjardy] [SBD] · Synjardy XR 25 MG / 1000 MG 24HR Extended Release Oral Tablet [SY]317These 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: 201520260120