Prescription drug · NDA
Opsynvi (Macitentan and tadalafil) NDC 66215-812
Macitentan 10 mg/1; Tadalafil 20 mg/1 · Tablet, Film coated · Oral · Actelion Pharmaceuticals US, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66215-812-07 | 6621508120766215081207 | 1 BOTTLE in 1 CARTON (66215-812-07) / 7 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 22, 2024 | |
| 66215-812-08 | 6621508120866215081208 | 1 BLISTER PACK in 1 CARTON (66215-812-08) / 7 TABLET, FILM COATED in 1 BLISTER PACK (66215-812-01)Marketed from Mar 22, 2024 | |
| 66215-812-30 | 6621508123066215081230 | 1 BOTTLE in 1 CARTON (66215-812-30) / 30 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 22, 2024 |
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)
- Opsynvi
- Generic name (nonproprietary)
- macitentan and tadalafil
- Active ingredients
- Macitentan — 10 mg/1Tadalafil — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Actelion Pharmaceuticals US, Inc.NDC labeler code 66215
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 218490
- Marketing start
- Listing expires
- Other FDA classes
- Endothelin Receptor Antagonists (Mechanism)Phosphodiesterase 5 Inhibitors (Mechanism)
- Identifiers
- Product ID 66215-812_32840e17-39b6-50b2-e063-6394a90a7a37SPL ID 32840e17-39b6-50b2-e063-6394a90a7a37SPL set ID 6945b183-18d3-40de-afd1-c88e33cc1a63RxCUI 2677765, 2677771, 2677773, 2677775UNII 742SXX0ICT, Z9K9Y9WMVL
- Pharmacologic class
- Endothelin Receptor Antagonist; Phosphodiesterase 5 Inhibitor
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
N466215081207followed by a unit qualifier and the quantityPackage 66215-0812-07. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
OPSYNVI is a combination of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor, indicated for chronic treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adult patients of WHO functional class (FC) II–III. ( 1.1 ) Individually, macitentan reduces the risk of clinical worsening events and hospitalization, and tadalafil improves exercise ability. ( 1.1 , 14 ) 1.1 Pulmonary Arterial Hypertension OPSYNVI is the combination of macitentan and tadalafil indicated for the chronic treatment of adults with pulmonary arterial hypertension (PAH, WHO Group I and WHO Functional Class (FC) II–III). Individually, macitentan reduces the r…
Excerpt only. Read the full label for complete information.
About NDC 66215-812
- What is NDC 66215-812?
- 66215-812 is the product NDC for Opsynvi, Macitentan 10 mg/1; Tadalafil 20 mg/1 tablet, film coated, listed with the FDA by Actelion Pharmaceuticals US, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Opsynvi (Macitentan and tadalafil).
- What is the active ingredient?
- Macitentan, Tadalafil.
- 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 Opsynvi?
- 1 other product NDC are listed under this name. See all Opsynvi NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Opsynvi products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Opsynvimacitentan and tadalafil | Macitentan 10 mg/1; Tadalafil 40 mg/1 | Tablet, Film coatedOral | Actelion Pharmaceuticals US, Inc. | 66215-814 | 66215-0814-1066215-0814-30 |
Other NDCs under NDA 218490
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 |
|---|---|---|---|---|
| Opsynvimacitentan and tadalafil | Macitentan 10 mg/1; Tadalafil 40 mg/1 | Tablet, Film coatedOral | Actelion Pharmaceuticals US, Inc. | 66215-814 |