Prescription drug · NDA
Uptravi (Selexipag) NDC 66215-612
Selexipag 1200 ug/1 · Tablet, Coated · Oral · Actelion Pharmaceuticals US, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66215-612-06 | 66215061206 | 1 BOTTLE in 1 CARTON (66215-612-06) / 60 TABLET, COATED in 1 BOTTLEMarketed from Dec 21, 2015 |
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)
- Uptravi
- Generic name (nonproprietary)
- selexipag
- Active ingredients
- Selexipag — 1200 ug/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Actelion Pharmaceuticals US, Inc.NDC labeler code 66215
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 207947
- Marketing start
- Listing expires
- Other FDA classes
- Prostacyclin Receptor Agonists (Mechanism)
- Identifiers
- Product ID 66215-612_7c54a125-9778-41f5-b92c-181711e22e06SPL ID 7c54a125-9778-41f5-b92c-181711e22e06SPL set ID a7a23b87-f892-4e2c-8e2e-ebf841220f90RxCUI 1729007, 1729013, 1729027, 1729029, 1729031, 1729033, 1729045, 1729047, 1729051, 1729053, 1729055, 1729057, 1729059, 1729061, 1729063, 1729065, 1729075, 1729076, 2565271, 2565275, 2744282, 2744284, 2744286, 2744288UNII 5EXC0E384LUPC 0366215612064, 0366215610060, 0366215604069, 0366215910146, 0366215606063, 0366215614068, 0366215616062
- Pharmacologic class
- Prostacyclin Receptor Agonist
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
N466215061206followed by a unit qualifier and the quantityPackage 66215-0612-06. 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)
UPTRAVI is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I): In adults to delay disease progression and reduce the risk of hospitalization for PAH. ( 1.1 ) In pediatric patients aged 2 years and older. UPTRAVI reduces NT-proBNP and is expected to delay disease progression and reduce the risk of hospitalization for PAH. ( 1.1 ) 1.1 Pulmonary Arterial Hypertension Adult Patients UPTRAVI is indicated for the treatment of pulmonary arterial hypertension in adults (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH. Effectiveness of UPTRAVI tablets was established in a long-term study in ad…
Excerpt only. Read the full label for complete information.
About NDC 66215-612
- What is NDC 66215-612?
- 66215-612 is the product NDC for Uptravi (selexipag), Selexipag 1200 ug/1 tablet, coated, listed with the FDA by Actelion Pharmaceuticals US, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Uptravi (Selexipag).
- What is the active ingredient?
- Selexipag.
- Who is the labeler?
- Actelion Pharmaceuticals US, Inc., NDC labeler code 66215. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Uptravi?
- 10 other product NDCs are listed under this name. See all Uptravi NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Uptravi products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Uptraviselexipag | Selexipag 150 ug/1 | Tablet, Film coatedOral | Actelion Pharmaceuticals US, Inc. | 66215-915 | 66215-0915-14 |
| Uptraviselexipag | Selexipag 100 ug/1 | Tablet, Film coatedOral | Actelion Pharmaceuticals US, Inc. | 66215-910 | 66215-0910-14 |
| Uptraviselexipag | Selexipag 1800 ug/10mL | Injection, Powder, For solutionIntravenous | Actelion Pharmaceuticals US, Inc. | 66215-718 | 66215-0718-01 |
| Uptraviselexipag | Selexipag 200 ug/1 | Tablet, CoatedOral | Actelion Pharmaceuticals US, Inc. | 66215-602 | 66215-0602-0666215-0602-14 |
| Uptraviselexipag | Selexipag 400 ug/1 | Tablet, CoatedOral | Actelion Pharmaceuticals US, Inc. | 66215-604 | 66215-0604-06 |
| Uptraviselexipag | Selexipag 600 ug/1 | Tablet, CoatedOral | Actelion Pharmaceuticals US, Inc. | 66215-606 | 66215-0606-06 |
| Uptraviselexipag | Selexipag 800 ug/1 | Tablet, CoatedOral | Actelion Pharmaceuticals US, Inc. | 66215-608 | 66215-0608-06 |
| Uptraviselexipag | Selexipag 1000 ug/1 | Tablet, CoatedOral | Actelion Pharmaceuticals US, Inc. | 66215-610 | 66215-0610-06 |
| Uptraviselexipag | Selexipag 1400 ug/1 | Tablet, CoatedOral | Actelion Pharmaceuticals US, Inc. | 66215-614 | 66215-0614-06 |
| Uptraviselexipag | Selexipag 1600 ug/1 | Tablet, CoatedOral | Actelion Pharmaceuticals US, Inc. | 66215-616 | 66215-0616-06 |
Other NDCs under NDA 207947
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 |
|---|---|---|---|---|
| Uptraviselexipag | Selexipag 150 ug/1 | Tablet, Film coatedOral | Actelion Pharmaceuticals US, Inc. | 66215-915 |
| Uptraviselexipag | Selexipag 200 ug/1 | Tablet, CoatedOral | Actelion Pharmaceuticals US, Inc. | 66215-602 |
| Uptraviselexipag | Selexipag 400 ug/1 | Tablet, CoatedOral | Actelion Pharmaceuticals US, Inc. | 66215-604 |
| Uptraviselexipag | Selexipag 600 ug/1 | Tablet, CoatedOral | Actelion Pharmaceuticals US, Inc. | 66215-606 |
| Uptraviselexipag | Selexipag 800 ug/1 | Tablet, CoatedOral | Actelion Pharmaceuticals US, Inc. | 66215-608 |
| Uptraviselexipag | Selexipag 1000 ug/1 | Tablet, CoatedOral | Actelion Pharmaceuticals US, Inc. | 66215-610 |
| Uptraviselexipag | Selexipag 1400 ug/1 | Tablet, CoatedOral | Actelion Pharmaceuticals US, Inc. | 66215-614 |
| Uptraviselexipag | Selexipag 1600 ug/1 | Tablet, CoatedOral | Actelion Pharmaceuticals US, Inc. | 66215-616 |
| UPTRAVI Titration Packselexipag | — | Kit | Actelion Pharmaceuticals US, Inc. | 66215-628 |
| Uptraviselexipag | Selexipag 100 ug/1 | Tablet, Film coatedOral | Actelion Pharmaceuticals US, Inc. | 66215-910 |