FDA.reportPublic FDA data

tenapanor 50 MG Oral Tablet [Ibsrela]

RxCUI
2199685
RxNorm name
tenapanor 50 MG Oral Tablet [Ibsrela]
Display name
tenapanor 50 MG Oral Tablet [Ibsrela]
Full name
tenapanor 50 MG Oral Tablet [Ibsrela]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:50

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
IBSRELATENAPANOR HYDROCHLORIDEArdelyx, Inc.2102da5f-a1a0-4ac7-a1f6-38698cf7273a2025-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2199685

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
2102da5f-a1a0-4ac7-a1f6-38698cf7273aIbsrela 50 MG Oral Tablet [PSN] · tenapanor 50 MG Oral Tablet [Ibsrela] [SBD] · Ibsrela 50 MG Oral Tablet [SY]311These highlights do not include all the information needed to use IBSRELA ® safely and effectively. See full prescribing information for IBSRELA. IBSRELA (tenapanor) tablets, for oral use Initial U.S. Approval: 201920250528