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NDC 66302-363 Orenitram

Treprostinil Kit - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 66302-363?
  4. Orenitram Uses
  5. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
66302-363
Proprietary Name:
Orenitram
Non-Proprietary Name: [1]
Treprostinil
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
United Therapeutics Corporation
Labeler Code:
66302
Product Label ID:
8ed2003a-c801-411e-831e-d06079bb0d7c
FDA Application Number: [6]
NDA203496
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
02-14-2023
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
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Product Details

What is NDC 66302-363?

The NDC code 66302-363 is assigned by the FDA to the product Orenitram which is a human prescription drug product labeled by United Therapeutics Corporation. The generic name of Orenitram is treprostinil. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 66302-363-84 1 kit in 1 package * 42 tablet, extended release in 1 blister pack * 84 tablet, extended release in 1 blister pack * 126 tablet, extended release in 1 blister pack. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Orenitram?

This medication is used to treat a type of high blood pressure in the lungs (pulmonary arterial hypertension). Treprostinil helps to increase your ability to exercise and improves symptoms such as shortness of breath and tiredness. It works by relaxing and widening the blood vessels (arteries) in the lungs and other parts of the body so that blood can flow more easily. This medication belongs to a class of drugs known as vasodilators.

What is the NDC to RxNorm Crosswalk for Orenitram?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1488665 - treprostinil 0.125 MG 12HR Extended Release Oral Tablet
  • RxCUI: 1488665 - 12 HR treprostinil 0.125 MG Extended Release Oral Tablet
  • RxCUI: 1488665 - treprostinil 0.125 MG (as treprostinil diethanolamine) 12 HR Extended Release Oral Tablet
  • RxCUI: 1488665 - treprostinil 0.125 MG (as treprostinil diolamine 0.159 MG) 12 HR Extended Release Oral Tablet
  • RxCUI: 1488667 - Orenitram 0.125 MG 12HR Extended Release Oral Tablet

* Please review the disclaimer below.

Product Footnotes

[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".