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NDC 00781-3425-80 Treprostinil 50 mg/20mL Details
Treprostinil 50 mg/20mL
Treprostinil is a INTRAVENOUS; SUBCUTANEOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sandoz Inc. The primary component is TREPROSTINIL.
MedlinePlus Drug Summary
Treprostinil injection 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 injection is also used to treat PAH when another medication (epoprostenol) did not help or could not be tolerated. 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 and platelet-aggregation inhibitors. It works by relaxing the blood vessels, including those in the lungs, and improving blood flow.
Related Packages: 00781-3425-80Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Treprostinil Injection
Product Information
| NDC | 00781-3425 |
|---|---|
| Product ID | 0781-3425_fe80d00e-9eba-4192-9515-f9a5ad686a53 |
| Associated GPIs | 40170080002060 |
| GCN Sequence Number | 050409 |
| GCN Sequence Number Description | treprostinil sodium VIAL 2.5 MG/ML INJECTION |
| HIC3 | B1C |
| HIC3 Description | PULMONARY ANTIHYPERTENSIVES, PROSTACYCLIN-TYPE |
| GCN | 17434 |
| HICL Sequence Number | 023650 |
| HICL Sequence Number Description | TREPROSTINIL SODIUM |
| Brand/Generic | Generic |
| Proprietary Name | Treprostinil |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | treprostinil |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAVENOUS; SUBCUTANEOUS |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/20mL |
| Substance Name | TREPROSTINIL |
| Labeler Name | Sandoz Inc |
| Pharmaceutical Class | Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA203649 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00781-3425-80 (00781342580)
| NDC Package Code | 0781-3425-80 |
|---|---|
| Billing NDC | 00781342580 |
| Package | 1 VIAL, MULTI-DOSE in 1 CARTON (0781-3425-80) / 20 mL in 1 VIAL, MULTI-DOSE |
| Marketing Start Date | 2019-03-25 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |