FDA.reportPublic FDA data

Tracleer 32 MG Tablet for Oral Suspension

RxCUI
1989085
RxNorm name
Tracleer 32 MG Tablet for Oral Suspension
Display name
Tracleer 32 MG Tablet for Oral Suspension
Full name
Tracleer 32 MG Tablet for Oral Suspension
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:03

RxNav Current And Historical NDCs#

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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: 1989085

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 32 MG Tablet for Oral Suspension [PSN] · bosentan 32 MG Tablet for Oral Suspension [Tracleer] [SBD] · Tracleer 32 MG Tablet for Oral Suspension [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