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NDC 66302-0350-02 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: 66302-0350-02Last 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 66302-0350-02 (66302035002)
| NDC Package Code | 66302-350-02 |
|---|---|
| Billing NDC | 66302035002 |
| Package | 1 BLISTER PACK in 1 CARTON (66302-350-02) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| Marketing Start Date | 2021-06-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |