FDA.reportPublic FDA data

Orenitram 1 MG (as treprostinil diolamine 1.27 MG) 12 HR Extended Release Oral Tablet

RxCUI
1488675
RxNorm name
Orenitram 1 MG (as treprostinil diolamine 1.27 MG) 12 HR Extended Release Oral Tablet
Display name
Orenitram 1 MG (as treprostinil diolamine 1.27 MG) 12 HR Extended Release Oral Tablet
Full name
Orenitram 1 MG (as treprostinil diolamine 1.27 MG) 12 HR Extended Release Oral Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:08

RxNav Current And Historical NDCs#

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UNII Substances#

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openFDA label cross-check#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OrenitramTREPROSTINILUnited Therapeutics Corporation8ed2003a-c801-411e-831e-d06079bb0d7c2024-11-20Warnings, Adverse reactionsExact identifier
rxcui: 1488675

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
8ed2003a-c801-411e-831e-d06079bb0d7cOrenitram 1 MG 12HR Extended Release Oral Tablet [PSN] · 12 HR treprostinil 1 MG Extended Release Oral Tablet [Orenitram] [SBD] · 12 HR Orenitram 1 MG Extended Release Oral Tablet [SY] · Orenitram 1 MG (as treprostinil diolamine 1.27 MG) 12 HR Extended Release Oral Tablet [SY]424These highlights do not include all the information needed to use ORENITRAM safely and effectively. See Full Prescribing Information for ORENITRAM. ORENITRAM ® (treprostinil) extended-release tablets, for oral use Initial U.S. Approval: 200220241120