66302-310 : Orenitram 1 mg/1 Oral Tablet, Extended Release

Labeler: United Therapeutics Corp.
Product Type: Human Prescription Drug
Drug Name:  Orenitram
Dosage Form: Oral Tablet, Extended Release
Application #: NDA203496
Rev. Date: 


Markings: UT;1
Shapes:  Round
Colors:  Yellow
Size (mm): 8
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 66302-310-01: 100 TABLET, EXTENDED RELEASE IN 1 BOTTLE (66302‑310‑01)
  • 66302-310-10: 10 TABLET, EXTENDED RELEASE IN 1 BOTTLE (66302‑310‑10)

Active Ingredients:

  • Treprostinil

Dosage Strength:

  • 1 mg

Inactive Ingredients:

  • Xylitol
  • Maltodextrin
  • Sodium Lauryl Sulfate
  • Magnesium Stearate
  • Cellulose Acetate
  • Triethyl Citrate
  • Polyvinyl Alcohol
  • Titanium Dioxide
  • Polyethylene Glycol 3350
  • Talc
  • Ferric Oxide Yellow
  • Ferric Oxide Red
  • Shellac
  • Ferrosoferric Oxide
  • Butyl Alcohol
  • Alcohol
  • Isopropyl Alcohol
  • Propylene Glycol

Pharmaceutical Classes:

  • Prostacycline Vasodilator [EPC]
  • Prostaglandins I [CS]
  • Vasodilation [PE]

Related Products:

Based on records with the same trade name.
  • 66302-300 Orenitram .125 mg/1 Oral Tablet, Extended Release by United Therapeutics Corp.
  • 66302-302 Orenitram .25 mg/1 Oral Tablet, Extended Release by United Therapeutics Corp.
  • 66302-325 Orenitram 2.5 mg/1 Oral Tablet, Extended Release by United Therapeutics Corp.
  • 66302-350 Orenitram 5 mg Oral Tablet, Extended Release by United Therapeutics Corp.
  • 69189-0676 Orenitram 2.5 mg Oral Tablet, Extended Release by Avera Mckennan Hospital


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