Labeler · US market

United Therapeutics Corporation

United Therapeutics Corporation is a US drug labeler with US FDA registrations covering 7 drug concepts (7 currently active) across 43 packages. It is currently the only active US supplier of 4 drugs.

ACTIVE — US

openFDA · updated weekly

Labeler codes66302

Active drugs7

Registrations35 active / 35

Packages43

Sole supplier of4 drugs

Portfolio7 drugs · US

Every drug concept this labeler has US registrations for, by package count.

Drug	Type	NDCs	Packages	Status
Treprostinil inhalant	rx	11	14	SUPPLYING
Treprostinil kit	rx	11	11	SUPPLYING
Treprostinil tablet, extended release	rx	5	10	SUPPLYING
Treprostinil injection, solution	rx	5	5	SUPPLYING
Water injection, solution	rx	1	1	SUPPLYING
Tadalafil tablet	rx	1	1	SUPPLYING
Dinutuximab injection	rx	1	1	SUPPLYING

Sole US supplier

Drugs where this labeler is currently the only active US supplier — a single point of failure if it exits.

At a glance

TypeLabeler
Labeler codes66302
Filing names1
Drugs (active)7
Drugs (all time)7
US registrations35
Packages43

Recent events

Shortages, recalls, and registration changes across all filing names.

Aug 14, 2018
RECALLRecall (Class III): Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation Solution. Treprostinil 1.74 mg/2…
Sep 11, 2017
RECALLRecall (Class II): TYVASO (treprostinil) Inhalation Solution Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) Tyvaso Inhalation System Starter Kit …
Mar 28, 2014
RECALLRecall (Class II): Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For Oral Inhalation Use On…

Watch this company

Alerts for recalls, exits, and new registrations.

Facility locations, FDA inspections, and parent-company mapping are on the roadmap. Name variants reported to FDA under different spellings are merged into this profile; figures cover the entity across all its filing names.