FDA.reportPublic FDA data

Tracleer 125 MG Oral Tablet

RxCUI
656660
RxNorm name
Tracleer 125 MG Oral Tablet
Display name
Tracleer 125 MG Oral Tablet
Full name
Tracleer 125 MG Oral Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:03

RxNav Current And Historical NDCs#

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UNII Substances#

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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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TracleerBOSENTANActelion Pharmaceuticals US, Inc.749e42fb-2fe0-45dd-9268-b43bb3f4081c2025-11-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 656660

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
749e42fb-2fe0-45dd-9268-b43bb3f4081cTracleer 125 MG Oral Tablet [PSN] · bosentan 125 MG Oral Tablet [Tracleer] [SBD] · Tracleer 125 MG Oral Tablet [SY]336These highlights do not include all the information needed to use TRACLEER safely and effectively. See full prescribing information for TRACLEER. TRACLEER ® (bosentan) tablets, for oral use TRACLEER ® (bosentan) tablets for oral suspension Initial U.S. Approval: 200120251117