FDA.reportPublic FDA data

bosentan (as bosentan hydrochloride) 125 MG Oral Tablet

RxCUI
656659
RxNorm name
bosentan (as bosentan hydrochloride) 125 MG Oral Tablet
Display name
bosentan (as bosentan hydrochloride) 125 MG Oral Tablet
Full name
bosentan (as bosentan hydrochloride) 125 MG Oral Tablet
Term type
SY
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#

UNII substance links page 1 of 1 · 0 matching rows.

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BosentanBOSENTANZydus Pharmaceuticals USA Inc.8444da17-6c31-492b-8842-93740f083d9d2026-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 656659
BosentanBOSENTANSun Pharmaceutical Industries, Inc.c006d8ef-8cb7-4fb3-88eb-b2debc302a202025-12-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 656659
bosentanBOSENTANActavis Pharma, Inc.39b2a85f-4322-42d4-b420-1b1d525691432025-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 656659
TracleerBOSENTANActelion Pharmaceuticals US, Inc.749e42fb-2fe0-45dd-9268-b43bb3f4081c2025-11-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 656659
BosentanBOSENTANZydus Lifesciences Limited02892f47-0d59-4254-9ee7-d524278fdd792024-11-25Exact identifier
rxcui: 656659

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
749e42fb-2fe0-45dd-9268-b43bb3f4081cbosentan 125 MG Oral TabletSCD36These 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
749e42fb-2fe0-45dd-9268-b43bb3f4081cbosentan 125 MG Oral TabletPSN36These 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
749e42fb-2fe0-45dd-9268-b43bb3f4081cbosentan (as bosentan hydrochloride) 125 MG Oral TabletSY36These 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
39b2a85f-4322-42d4-b420-1b1d52569143bosentan (as bosentan hydrochloride) 125 MG Oral TabletSY24These highlights do not include all the information needed to use BOSENTAN TABLETS safely and effectively. See full prescribing information for BOSENTAN TABLETS. BOSENTAN tablets, for oral use Initial U.S. Approval: 200120251130
39b2a85f-4322-42d4-b420-1b1d52569143bosentan 125 MG Oral TabletPSN24These highlights do not include all the information needed to use BOSENTAN TABLETS safely and effectively. See full prescribing information for BOSENTAN TABLETS. BOSENTAN tablets, for oral use Initial U.S. Approval: 200120251130
39b2a85f-4322-42d4-b420-1b1d52569143bosentan 125 MG Oral TabletSCD24These highlights do not include all the information needed to use BOSENTAN TABLETS safely and effectively. See full prescribing information for BOSENTAN TABLETS. BOSENTAN tablets, for oral use Initial U.S. Approval: 200120251130
c006d8ef-8cb7-4fb3-88eb-b2debc302a20bosentan 125 MG Oral TabletSCD9These highlights do not include all the information needed to use BOSENTAN TABLETS safely and effectively. See full prescribing information for BOSENTAN TABLETS. BOSENTAN tablets, for oral use Initial U.S. Approval: 200120251222
c006d8ef-8cb7-4fb3-88eb-b2debc302a20bosentan (as bosentan hydrochloride) 125 MG Oral TabletSY9These highlights do not include all the information needed to use BOSENTAN TABLETS safely and effectively. See full prescribing information for BOSENTAN TABLETS. BOSENTAN tablets, for oral use Initial U.S. Approval: 200120251222
c006d8ef-8cb7-4fb3-88eb-b2debc302a20bosentan 125 MG Oral TabletPSN9These highlights do not include all the information needed to use BOSENTAN TABLETS safely and effectively. See full prescribing information for BOSENTAN TABLETS. BOSENTAN tablets, for oral use Initial U.S. Approval: 200120251222
02892f47-0d59-4254-9ee7-d524278fdd79bosentan 125 MG Oral TabletPSN6BOSENTAN TABLETS20241125
02892f47-0d59-4254-9ee7-d524278fdd79bosentan 125 MG Oral TabletSCD6BOSENTAN TABLETS20241125
02892f47-0d59-4254-9ee7-d524278fdd79bosentan (as bosentan hydrochloride) 125 MG Oral TabletSY6BOSENTAN TABLETS20241125