Prescription drug · NDA
Orenitram (treprostinil) NDC 66302-325
Treprostinil 2.5 mg/1 · Tablet, Extended release · Oral · United Therapeutics Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66302-325-01 | 66302032501 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (66302-325-01)Marketed from Dec 20, 2013 | |
| 66302-325-02 | 66302032502 | 1 BLISTER PACK in 1 CARTON (66302-325-02) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 30, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Orenitram
- Generic name (nonproprietary)
- treprostinil
- Active ingredients
- Treprostinil — 2.5 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 203496
- Marketing start
- Listing expires
- Other FDA classes
- Prostaglandins I (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 66302-325_bd66c62e-4aee-4fd0-bc7d-f78994dd9e29SPL ID bd66c62e-4aee-4fd0-bc7d-f78994dd9e29SPL set ID 8ed2003a-c801-411e-831e-d06079bb0d7cRxCUI 1488665, 1488667, 1488670, 1488671, 1488674, 1488675, 1488678, 1488679, 1858831, 1858833, 2630666, 2630667, 2630668, 2630669, 2630670, 2630671UNII RUM6K67ESG
- Pharmacologic class
- Prostacycline Vasodilator
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N466302032501followed by a unit qualifier and the quantityPackage 66302-0325-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Orenitram is a prostacyclin mimetic indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): To delay disease progression and to improve exercise capacity. The studies that established effectiveness included predominately patients with WHO functional class II-III symptoms and etiologies of idiopathic or heritable PAH (66%) or PAH associated with connective tissue disease (26%). ( 1.1 ) 1.1 Pulmonary Arterial Hypertension Orenitram is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to delay disease progression and to improve exercise capacity. The studies that established effectiveness included predominately patients with WHO funct…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 203496
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Orenitramtreprostinil | Treprostinil .125 mg/1 | Tablet, Extended releaseOral | United Therapeutics Corporation | 66302-300 |
| Orenitramtreprostinil | Treprostinil .25 mg/1 | Tablet, Extended releaseOral | United Therapeutics Corporation | 66302-302 |
| Orenitramtreprostinil | Treprostinil 1 mg/1 | Tablet, Extended releaseOral | United Therapeutics Corporation | 66302-310 |
| Orenitramtreprostinil | Treprostinil 5 mg/1 | Tablet, Extended releaseOral | United Therapeutics Corporation | 66302-350 |
| Orenitramtreprostinil | — | Kit | United Therapeutics Corporation | 66302-361 |
| Orenitramtreprostinil | — | Kit | United Therapeutics Corporation | 66302-362 |
| Orenitramtreprostinil | — | Kit | United Therapeutics Corporation | 66302-363 |