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Brand-name prescription medicine

Tyvaso DPI

Generic name: Treprostinil

FDA application holder: United Therap

Strengths and generic versions Official label

Official data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the NDC Directory, Drugs@FDA, the official labels and recall reports; pharmacy costs come from the Centers for Medicare & Medicaid Services (CMS). Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or switch any medicine, including a switch between a brand and a generic.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

5Strengths and forms
0Same medicine, other names
2022FDA approval
0Recalls (FDA reports)

Quick answers

What is Tyvaso DPI?
Tyvaso DPI is a brand name of Treprostinil, a prescription medicine. The FDA NDC Directory lists 10 Tyvaso DPI products in 5 strengths and forms.
Who makes Tyvaso DPI?
United Therap holds the FDA application for Tyvaso DPI (NDA214324, approved May 23, 2022).
Is there a generic or store brand of Tyvaso DPI?
Other products of Treprostinil are listed with the FDA, but none in exactly the same strength and form as a Tyvaso DPI product.
Has Tyvaso DPI been recalled?
No recall linked to Tyvaso DPI products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Tyvaso DPI is

Each Tyvaso DPI product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.

Treprostinil · prescription medicine

Strength and formProduct namesSame medicine, other namesLabel
treprostinil 16 ug
inhalant (oral)		 Tyvaso DPI None listed DailyMed
treprostinil 32 ug
inhalant (oral)		 Tyvaso DPI None listed DailyMed
treprostinil 48 ug
inhalant (oral)		 Tyvaso DPI None listed DailyMed
treprostinil 64 ug
inhalant (oral)		 Tyvaso DPI None listed DailyMed
treprostinil 80 ug
inhalant (oral)		 Tyvaso DPI None listed DailyMed

Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Treprostinil →

FDA approval

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
FDA applications of Tyvaso DPI products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
NDA214324United TherapMay 23, 202210

Companies that list Tyvaso DPI

The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Tyvaso DPI products.

Recalls

No recall linked to Tyvaso DPI products (by their NDC code or label) appears in the FDA enforcement reports.

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026

Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.

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