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Active ingredient

Treprostinil

41 finished FDA listings contain Treprostinil as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
TREPROSTINIL, TREPROSTINIL DIOLAMINE, TREPROSTINIL SODIUM
Dosage forms
Capsule, Inhalant, Injection, Injection, Solution, Tablet, Extended Release
Routes
Intravenous, Oral, Respiratory (Inhalation), Subcutaneous
Manufacturers / labelers
6
Strengths listed
.125 mg/1 · .25 mg/1 · 1 mg/1 · 1.74 mg/2.9ml · 100 mg/20ml · 106 ug/1 · 16 ug/1 · 2.5 mg/1 · 20 mg/20ml · 200 mg/20ml · 26.5 ug/1 · 32 ug/1 · 48 ug/1 · 5 mg/1 · 50 mg/20ml · 53 ug/1 · 64 ug/1 · 79.5 ug/1 · 8 mg/20ml · 80 ug/1
Brand names in FDA listings
Orenitram, Remodulin, Tyvaso, Tyvaso Dpi, Yutrepia

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 343048

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 021272UNITED THERAP2002-05-215
NDA 022387UNITED THERAP2009-07-301
NDA 203496UNITED THERAP2013-12-205
ANDA 203649SANDOZ2017-11-304
ANDA 206648TEVA PHARMS USA2019-09-264
ANDA 210214DR REDDYS2020-05-224
ANDA 211574ALEMBIC GLOBAL2021-02-114
NDA 214324UNITED THERAP2022-05-2310
NDA 213005LIQUIDIA TECH2025-05-234

Official labeling on DailyMed

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.