FDA.reportPublic FDA data

Tracleer 62.5 MG Oral Tablet

RxCUI
352066
RxNorm name
Tracleer 62.5 MG Oral Tablet
Display name
Tracleer 62.5 MG Oral Tablet
Full name
Tracleer 62.5 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:03

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

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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
TracleerBOSENTANActelion Pharmaceuticals US, Inc.749e42fb-2fe0-45dd-9268-b43bb3f4081c2025-11-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 352066

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 62.5 MG Oral Tablet [PSN] · bosentan 62.5 MG Oral Tablet [Tracleer] [SBD] · Tracleer 62.5 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