FDA.reportPublic FDA data

TREPROSTINIL - Food and Drug Administration

Manufacturer
Food and Drug Administration
Effective date
2023-01-26
Label type
Indexing - product concept
Version
1
Source
full-release
Hydrated at
2026-06-05 00:20:54

Label at a glance#

ProductTREPROSTINIL
Active ingredientTREPROSTINIL

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
TREPROSTINILRUM6K67ESGACTIB
TREPROSTINILRUM6K67ESGACTIB
TREPROSTINILRUM6K67ESGACTIB
TREPROSTINILRUM6K67ESGACTIB

Source Document#

Source XML

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsName fallback
generic name: TREPROSTINIL
TYVASOTREPROSTINILUnited Therapeutics Corporationcbc31ab1-a80f-4b50-a3b1-39910b0fb6092026-04-14Warnings, Adverse reactionsName fallback
generic name: TREPROSTINIL
Tyvaso DPITREPROSTINILUnited Therapeutics Corporationddc3d400-bcb3-4b09-aae2-0768b10a5b0f2025-11-20Warnings, Adverse reactionsName fallback
generic name: TREPROSTINIL
YutrepiaTREPROSTINILLiquidia Technologies, Inc.e8f6d534-115c-440e-bdbb-b443a29bb4682025-09-08Warnings, Adverse reactionsName fallback
generic name: TREPROSTINIL
TreprostinilTREPROSTINILAlembic Pharmaceuticals Inc.4a684b13-669d-4721-8ed4-30cc7762b0b82025-02-13Warnings, Adverse reactionsName fallback
brand name: Treprostinil
generic name: TREPROSTINIL
OrenitramTREPROSTINILUnited Therapeutics Corporation8ed2003a-c801-411e-831e-d06079bb0d7c2024-11-20Warnings, Adverse reactionsName fallback
generic name: TREPROSTINIL
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsName fallback
brand name: Treprostinil
generic name: TREPROSTINIL
TreprostinilTREPROSTINILTeva Parenteral Medicines, Inc.4b2ce4aa-4302-49db-9456-c8cf0e0349682022-05-01Warnings, Adverse reactionsName fallback
brand name: Treprostinil
generic name: TREPROSTINIL
Sterile Diluent for TreprostinilWATERDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsName fallback
brand name: Treprostinil
generic name: TREPROSTINIL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.