Prescription drug · NDA
Tyvaso DPI (Treprostinil) NDC 66302-748
Treprostinil 48 ug/1 · Inhalant · Oral · United Therapeutics Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66302-748-04 | 66302074804 | 1 BLISTER PACK in 1 KIT (66302-748-04) / 4 BLISTER PACK in 1 BLISTER PACK / 4 INHALANT in 1 BLISTER PACKMarketed from May 23, 2022 |
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 DPI
- Generic name (nonproprietary)
- treprostinil
- Active ingredients
- Treprostinil — 48 ug/1
- Dosage form
- Inhalant
- Route
- Oral
- Labeler
- United Therapeutics CorporationNDC labeler code 66302
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 214324
- Marketing start
- Listing expires
- Other FDA classes
- Prostaglandins I (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 66302-748_81912284-3d3a-430e-a55e-df239b084535SPL ID 81912284-3d3a-430e-a55e-df239b084535SPL set ID ddc3d400-bcb3-4b09-aae2-0768b10a5b0fRxCUI 2602751, 2602754, 2602756, 2602758, 2602760, 2602762, 2602764, 2602766, 2602767, 2602768, 2602769, 2602770, 2602771, 2602772, 2602773, 2602774, 2641906, 2641907, 2641911, 2641912, 2641913, 2641914, 2697737, 2697739, 2727470, 2727471, 2727472, 2727473UNII 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
N466302074804followed by a unit qualifier and the quantityPackage 66302-0748-04. 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 DPI is a prostacyclin mimetic indicated for the treatment of: Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies with Tyvaso 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 with Tyvaso establishing effectiveness predominately included patients with etiologies of idiopathic interstitial pneumonia (IIP) (45%) inclusive of idiopathic pulmonary fibrosis (IPF), com…
Excerpt only. Read the full label for complete information.
About NDC 66302-748
- What is NDC 66302-748?
- 66302-748 is the product NDC for Tyvaso DPI (treprostinil), Treprostinil 48 ug/1 inhalant, listed with the FDA by United Therapeutics Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tyvaso DPI (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 DPI?
- 17 other product NDCs are listed under this name. See all Tyvaso DPI NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tyvaso DPI products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tyvaso DPItreprostinil | — | Kit | United Therapeutics Corporation | 66302-660 | 66302-0660-03 |
| Tyvaso DPItreprostinil | — | Kit | United Therapeutics Corporation | 66302-670 | 66302-0670-03 |
| Tyvaso DPItreprostinil | Treprostinil 80 ug/1 | InhalantOral | United Therapeutics Corporation | 66302-680 | 66302-0680-03 |
| Tyvaso DPItreprostinil | Treprostinil 80 ug/1 | InhalantOral | United Therapeutics Corporation | 66302-780 | 66302-0780-04 |
| Tyvaso DPItreprostinil | — | Kit | United Therapeutics Corporation | 66302-630 | 66302-0630-03 |
| Tyvaso DPItreprostinil | — | Kit | United Therapeutics Corporation | 66302-640 | 66302-0640-03 |
| Tyvaso DPItreprostinil | — | Kit | United Therapeutics Corporation | 66302-650 | 66302-0650-03 |
| Tyvaso DPItreprostinil | — | Kit | United Therapeutics Corporation | 66302-610 | 66302-0610-02 |
| Tyvaso DPItreprostinil | Treprostinil 16 ug/1 | InhalantOral | United Therapeutics Corporation | 66302-616 | 66302-0616-03 |
| Tyvaso DPItreprostinil | — | Kit | United Therapeutics Corporation | 66302-620 | 66302-0620-03 |
Other NDCs under NDA 214324
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 |
|---|---|---|---|---|
| Tyvaso DPItreprostinil | — | Kit | United Therapeutics Corporation | 66302-610 |
| Tyvaso DPItreprostinil | Treprostinil 16 ug/1 | InhalantOral | United Therapeutics Corporation | 66302-616 |
| Tyvaso DPItreprostinil | — | Kit | United Therapeutics Corporation | 66302-620 |
| Tyvaso DPItreprostinil | — | Kit | United Therapeutics Corporation | 66302-630 |
| Tyvaso DPItreprostinil | Treprostinil 32 ug/1 | InhalantOral | United Therapeutics Corporation | 66302-632 |
| Tyvaso DPItreprostinil | — | Kit | United Therapeutics Corporation | 66302-640 |
| Tyvaso DPItreprostinil | Treprostinil 48 ug/1 | InhalantOral | United Therapeutics Corporation | 66302-648 |
| Tyvaso DPItreprostinil | — | Kit | United Therapeutics Corporation | 66302-650 |
| Tyvaso DPItreprostinil | — | Kit | United Therapeutics Corporation | 66302-660 |
| Tyvaso DPItreprostinil | Treprostinil 64 ug/1 | InhalantOral | United Therapeutics Corporation | 66302-664 |
| Tyvaso DPItreprostinil | — | Kit | United Therapeutics Corporation | 66302-670 |
| Tyvaso DPItreprostinil | Treprostinil 80 ug/1 | InhalantOral | United Therapeutics Corporation | 66302-680 |
| Tyvaso DPItreprostinil | Treprostinil 16 ug/1 | InhalantOral | United Therapeutics Corporation | 66302-716 |
| Tyvaso DPItreprostinil | — | Kit | United Therapeutics Corporation | 66302-720 |
| Tyvaso DPItreprostinil | Treprostinil 32 ug/1 | InhalantOral | United Therapeutics Corporation | 66302-732 |
| Tyvaso DPItreprostinil | Treprostinil 64 ug/1 | InhalantOral | United Therapeutics Corporation | 66302-764 |
| Tyvaso DPItreprostinil | Treprostinil 80 ug/1 | InhalantOral | United Therapeutics Corporation | 66302-780 |