OpenRx Open Medications Explorer
© 2026 OpenRx · public-domain U.S. government data
On this page

Remodulin

treprostinil · Injection, Solution

Prescription NDA TE AP RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Remodulin
Generic name
treprostinil
Dosage form
Injection, Solution
Route
Intravenous
Marketing category
NDA · NDA
Labeler
United Therapeutics Corporation
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
5
NDC product codes
5
Packages
5
Data completeness
60% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Treprostinil 100 mg/20mL 349407 View
Treprostinil 20 mg/20mL 349407 View
Treprostinil 200 mg/20mL 349407 View
Treprostinil 50 mg/20mL 349407 View
Treprostinil 8 mg/20mL 349407 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Injection, Solution
Route of administration
Intravenous
Presentations
10

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Prostacycline Vasodilator [EPC] EPC 8 members — no class page
Prostaglandins I [CS] CS 8 members — no class page
Vasodilation [PE] PE All 31 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
021272
Application type
NDA · New Drug Application
Approval date
May 21, 2002
Sponsor
UNITED THERAP
Products on application
8
Submissions recorded
17
Products approved under application 021272.
Product Trade name Form Strength Ingredient Status TE Flags
021272-001 REMODULIN INJECTABLE TREPROSTINIL Prescription AP RLD RS
021272-002 REMODULIN INJECTABLE TREPROSTINIL Prescription AP RLD RS
021272-003 REMODULIN INJECTABLE TREPROSTINIL Prescription AP RLD RS
021272-004 REMODULIN INJECTABLE TREPROSTINIL Prescription AP RLD RS
021272-005 REMODULIN INJECTABLE TREPROSTINIL Discontinued — RLD
021272-006 REMODULIN INJECTABLE TREPROSTINIL Discontinued — RLD
021272-007 REMODULIN INJECTABLE TREPROSTINIL Discontinued — RLD
021272-008 REMODULIN INJECTABLE TREPROSTINIL Prescription — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
AP
Reference Listed Drug
Yes
Reference Standard
Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated (parenteral aqueous solutions)

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
8653137 September 5, 2028 001 No U-1437 February 18, 2014
8658694 September 5, 2028 001 No U-1437 February 25, 2014
8658694 September 5, 2028 002 No U-1437 February 25, 2014
8653137 September 5, 2028 002 No U-1437 February 18, 2014
8653137 September 5, 2028 003 No U-1437 February 18, 2014
8658694 September 5, 2028 003 No U-1437 February 25, 2014
8653137 September 5, 2028 004 No U-1437 February 18, 2014
8658694 September 5, 2028 004 No U-1437 February 25, 2014
8653137 September 5, 2028 005 No U-1437 August 24, 2021
8658694 September 5, 2028 005 No U-1437 August 24, 2021
8658694 September 5, 2028 006 No U-1437 October 20, 2023
8653137 September 5, 2028 006 No U-1437 October 20, 2023
8658694 September 5, 2028 007 No U-1437 October 20, 2023
8653137 September 5, 2028 007 No U-1437 October 20, 2023
8658694 September 5, 2028 008 No U-1437 October 20, 2023
8653137 September 5, 2028 008 No U-1437 October 20, 2023
11723887 December 15, 2028 001 Yes August 15, 2023
9593066 December 15, 2028 001 Yes March 14, 2017
11723887 December 15, 2028 002 Yes August 15, 2023
9593066 December 15, 2028 002 Yes March 14, 2017
9593066 December 15, 2028 003 Yes March 14, 2017
11723887 December 15, 2028 003 Yes August 15, 2023
11723887 December 15, 2028 004 Yes August 15, 2023
9593066 December 15, 2028 004 Yes March 14, 2017
11723887 December 15, 2028 005 Yes August 15, 2023
9593066 December 15, 2028 005 Yes August 24, 2021
11723887 December 15, 2028 006 Yes October 20, 2023
9593066 December 15, 2028 006 Yes October 20, 2023
9593066 December 15, 2028 007 Yes October 20, 2023
11723887 December 15, 2028 007 Yes October 20, 2023
9593066 December 15, 2028 008 Yes October 20, 2023
11723887 December 15, 2028 008 Yes October 20, 2023
7999007 March 29, 2029 001 No U-1437 August 23, 2011
7999007 March 29, 2029 002 No U-1437 —
7999007 March 29, 2029 003 No U-1437 —
7999007 March 29, 2029 004 No U-1437 —
7999007 March 29, 2029 005 No U-1437 August 24, 2021
7999007 March 29, 2029 006 No U-1437 October 20, 2023
7999007 March 29, 2029 007 No U-1437 October 20, 2023
7999007 March 29, 2029 008 No U-1437 October 20, 2023

Approval history

Source: Drugs@FDA
Most recent submissions on application 021272.
Type No. Action Status Date Review
Supplement 37 Labeling Approved March 7, 2023 Standard
Supplement 32 Manufacturing (CMC) Approved July 30, 2021 N/A
Supplement 30 Manufacturing (CMC) Tentative approval August 19, 2020 N/A
Supplement 25 Labeling Approved July 30, 2018 Standard
Supplement 26 Labeling Approved June 8, 2018 Standard
Supplement 22 Manufacturing (CMC) Approved January 22, 2016 Priority
Supplement 19 Manufacturing (CMC) Approved December 22, 2014 N/A
Supplement 21 Manufacturing (CMC) Approved January 3, 2014 Priority
Supplement 20 Labeling Approved September 26, 2013 Standard
Supplement 15 Labeling Approved February 8, 2011 Unknown
Supplement 11 Labeling Approved January 8, 2010 Standard
Supplement 8 Labeling Approved September 12, 2008 Standard
Supplement 9 Labeling Approved February 4, 2008 Standard
Supplement 5 Efficacy Approved March 20, 2006 Priority
Supplement 3 Labeling Approved January 20, 2006 Standard
Supplement 2 Efficacy Approved November 24, 2004 Standard
Original application 1 Type 1 - New Molecular Entity Approved May 21, 2002 Priority

Review documents

  • 0 · Supplement · April 25, 2023
  • 0 · Supplement · March 8, 2023
  • 0 · Supplement · September 13, 2021
  • 0 · Supplement · September 13, 2021
  • 0 · Supplement · March 23, 2021
  • 0 · Supplement · February 17, 2021
  • 0 · Supplement · August 3, 2018
  • 0 · Supplement · July 31, 2018
  • 0 · Supplement · June 14, 2018
  • 0 · Supplement · June 12, 2018
  • 0 · Supplement · September 27, 2016
  • 0 · Supplement · November 18, 2015
  • 0 · Supplement · December 30, 2014
  • 0 · Supplement · January 16, 2014
  • 0 · Supplement · October 1, 2013
  • 0 · Supplement · September 27, 2013
  • 0 · Supplement · September 27, 2013
  • 0 · Supplement · September 26, 2013
  • 0 · Supplement · October 10, 2011
  • 0 · Supplement · February 14, 2011
  • 0 · Supplement · February 9, 2011
  • 0 · Supplement · January 15, 2010
  • 0 · Supplement · January 12, 2010
  • 0 · Supplement · September 19, 2008
  • 0 · Supplement · September 16, 2008
  • 0 · Supplement · February 14, 2008
  • 0 · Supplement · February 7, 2008
  • 0 · Supplement · March 23, 2006
  • 0 · Supplement · March 22, 2006
  • 0 · Supplement · January 30, 2006

Adverse event reports

Source: openFDA FAERS
124,759
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: TREPROSTINIL. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
66302-101-01 66302-101 United Therapeutics Corporation 1 VIAL in 1 BOX (66302-101-01) / 20 mL in 1 VIAL May 22, 2002
66302-102-01 66302-102 United Therapeutics Corporation 1 VIAL in 1 BOX (66302-102-01) / 20 mL in 1 VIAL May 22, 2002
66302-105-01 66302-105 United Therapeutics Corporation 1 VIAL in 1 BOX (66302-105-01) / 20 mL in 1 VIAL May 22, 2002
66302-110-01 66302-110 United Therapeutics Corporation 1 VIAL in 1 BOX (66302-110-01) / 20 mL in 1 VIAL May 22, 2002
66302-114-01 66302-114 United Therapeutics Corporation 1 VIAL in 1 BOX (66302-114-01) / 20 mL in 1 VIAL September 28, 2023
66302-101 66302-101 United Therapeutics Corporation — May 22, 2002
66302-102 66302-102 United Therapeutics Corporation — May 22, 2002
66302-105 66302-105 United Therapeutics Corporation — May 22, 2002
66302-110 66302-110 United Therapeutics Corporation — May 22, 2002
66302-114 66302-114 United Therapeutics Corporation — September 28, 2023

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.