Prescription drug · NDA
Tyvaso (Treprostinil) NDC 66302-206
Treprostinil 1.74 mg/2.9mL · Inhalant · Oral · United Therapeutics Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66302-206-01 | 66302020601 | 1 BOX in 1 KIT (66302-206-01) / 28 AMPULE in 1 BOX / 2.9 mL in 1 AMPULEMarketed from Aug 14, 2009 | |
| 66302-206-02 | 66302020602 | 1 BOX in 1 KIT (66302-206-02) / 28 AMPULE in 1 BOX / 2.9 mL in 1 AMPULEMarketed from Aug 14, 2009 | |
| 66302-206-03 | 66302020603 | 4 AMPULE in 1 BOX (66302-206-03) / 2.9 mL in 1 AMPULEMarketed from Aug 14, 2009 | |
| 66302-206-04 | 66302020604 | 1 BOX in 1 KIT (66302-206-04) / 4 AMPULE in 1 BOX / 2.9 mL in 1 AMPULEMarketed from Aug 14, 2009 |
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)
- Tyvaso
- Generic name (nonproprietary)
- treprostinil
- Active ingredients
- Treprostinil — 1.74 mg/2.9mL
- Dosage form
- Inhalant
- Route
- Oral
- Labeler
- United Therapeutics CorporationNDC labeler code 66302
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022387
- Marketing start
- Listing expires
- Other FDA classes
- Prostaglandins I (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 66302-206_78a0b514-481a-4ea9-8ec6-8b60acdf2158SPL ID 78a0b514-481a-4ea9-8ec6-8b60acdf2158SPL set ID cbc31ab1-a80f-4b50-a3b1-39910b0fb609RxCUI 857795, 857799UNII 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
N466302020601followed by a unit qualifier and the quantityPackage 66302-0206-01. 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)
Tyvaso is a prostacyclin mimetic indicated for the treatment of: Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies establishing effectiveness predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%). ( 1.1 ) Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. The study establishing effectiveness predominately included patients with etiologies of idiopathic interstitial pneumonia (IIP) (45%) inclusive of idiopathic pulmonary fibrosis (IPF), combined pulmonary fibrosis and…
Excerpt only. Read the full label for complete information.
About NDC 66302-206
- What is NDC 66302-206?
- 66302-206 is the product NDC for Tyvaso (treprostinil), Treprostinil 1.74 mg/2.9mL inhalant, listed with the FDA by United Therapeutics Corporation. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tyvaso (Treprostinil).
- What is the active ingredient?
- Treprostinil.
- Who is the labeler?
- United Therapeutics Corporation, NDC labeler code 66302. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tyvaso?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.