Search by Drug Name or NDC

NDC 66302-0350-01 Orenitram 5 mg/1 Details

Orenitram 5 mg/1

Orenitram is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by United Therapeutics Corporation. The primary component is TREPROSTINIL.

MedlinePlus Drug Summary

Treprostinil is used to treat certain kinds of pulmonary arterial hypertension (PAH; high blood pressure in the vessels carrying blood to the lungs, causing shortness of breath, dizziness, and tiredness). Treprostinil may improve the ability to exercise and slow the worsening of symptoms in patients with PAH. Treprostinil is in a class of medications called vasodilators. It works by relaxing the blood vessels, including those in the lungs, and improving blood flow.

Related Packages: 66302-0350-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Treprostinil

Product Information

NDC	66302-0350
Product ID	66302-350_e9babc9a-fe4f-4da1-9110-4425b17f2381
Associated GPIs	40170080050435
GCN Sequence Number	077482
GCN Sequence Number Description	treprostinil diolamine TABLET ER 5 MG ORAL
HIC3	B1C
HIC3 Description	PULMONARY ANTIHYPERTENSIVES, PROSTACYCLIN-TYPE
GCN	43521
HICL Sequence Number	040827
HICL Sequence Number Description	TREPROSTINIL DIOLAMINE
Brand/Generic	Brand
Proprietary Name	Orenitram
Proprietary Name Suffix	n/a
Non-Proprietary Name	treprostinil
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	5
Active Ingredient Units	mg/1
Substance Name	TREPROSTINIL
Labeler Name	United Therapeutics Corporation
Pharmaceutical Class	Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA203496
Listing Certified Through	2024-12-31

Package

NDC 66302-0350-01 (66302035001)

Pricing Information	N/A
NDC Package Code	66302-350-01
Billing NDC	66302035001
Package	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (66302-350-01)
Marketing Start Date	2013-12-20
NDC Exclude Flag	N