NDC 66302-350

Orenitram

Treprostinil

Orenitram is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by United Therapeutics Corp.. The primary component is Treprostinil.

Product ID66302-350_16af28d7-7142-4683-837f-004d106d19ea
NDC66302-350
Product TypeHuman Prescription Drug
Proprietary NameOrenitram
Generic NameTreprostinil
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2013-12-20
Marketing CategoryNDA / NDA
Application NumberNDA203496
Labeler NameUnited Therapeutics Corp.
Substance NameTREPROSTINIL
Active Ingredient Strength5 mg/1
Pharm ClassesProstacycline Vasodilator [EPC],Prostaglandins I [CS],Vasodilation [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 66302-350-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (66302-350-01)
Marketing Start Date2013-12-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66302-350-10 [66302035010]

Orenitram TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA203496
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-12-20

NDC 66302-350-01 [66302035001]

Orenitram TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA203496
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-12-20

Drug Details

Active Ingredients

IngredientStrength
TREPROSTINIL5 mg/1

OpenFDA Data

SPL SET ID:8ed2003a-c801-411e-831e-d06079bb0d7c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1488675
  • 1488674
  • 1488671
  • 1488667
  • 1488665
  • 1858833
  • 1858831
  • 1488679
  • 1488678
  • 1488670

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Orenitram" or generic name "Treprostinil"

    NDCBrand NameGeneric Name
    66302-310OrenitramOrenitram
    66302-350OrenitramOrenitram
    66302-300OrenitramOrenitram
    66302-302OrenitramOrenitram
    66302-325OrenitramOrenitram
    66302-101Remodulintreprostinil
    66302-102Remodulintreprostinil
    0703-0666TreprostinilTreprostinil
    0703-0676TreprostinilTreprostinil
    0703-0686TreprostinilTreprostinil
    0703-0696TreprostinilTreprostinil
    0781-3420Treprostiniltreprostinil
    0781-3425Treprostiniltreprostinil
    0781-3427Treprostiniltreprostinil
    0781-3430Treprostiniltreprostinil
    42023-206TreprostinilTreprostinil
    42023-207TreprostinilTreprostinil
    42023-208TreprostinilTreprostinil
    42023-209TreprostinilTreprostinil
    62332-514TreprostinilTreprostinil
    62332-515TreprostinilTreprostinil
    62332-516TreprostinilTreprostinil
    62332-517TreprostinilTreprostinil

    Trademark Results [Orenitram]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ORENITRAM
    ORENITRAM
    85755001 4548443 Live/Registered
    United Therapeutics Corporation
    2012-10-16
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