United States· US:66215-812_32840e17-39b6-50b2-e063-6394a90a7a37
OPSYNVI
A macitentan and tadalafil product containing macitentan; tadalafil, registered in United States by Actelion Pharmaceuticals US, Inc.. The same ATC class is registered in 11 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Macitentan and tadalafil is registered in 11 of 19 countries.
Countries holding a registration under ATC C02KX54 (macitentan and tadalafil), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 7 of them publish a price we can compare per daily dose
Macitentan and tadalafil · ATC C02KX54
11 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Polandprice
- Switzerlandprice
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- MACITENTAN; TADALAFIL
- Manufacturer
- Actelion Pharmaceuticals US, Inc.
- Country
- United States (US)
- ATC code
- C02KX54
- ATC class
- Macitentan and tadalafil
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 6
- ndc1166215-812-30
- ndc1166215-812-07
- ndc1166215-812-08
- ndc1166215812071 BOTTLE in 1 CARTON (66215-812-07) / 7 TABLET, FILM COATED in 1 BOTTLE
- ndc1166215812081 BLISTER PACK in 1 CARTON (66215-812-08) / 7 TABLET, FILM COATED in 1 BLISTER PACK (66215-812-01)
- ndc1166215812301 BOTTLE in 1 CARTON (66215-812-30) / 30 TABLET, FILM COATED in 1 BOTTLE
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Macitentan and tadalafil in 10 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaYUVANCIJanssen-Cilag International N.V., Beerse
- PolandYuvanciJanssen-Cilag International N.V.
- FinlandYuvanciJanssen-Cilag International NV
- SwedenYuvanci 10 mg/20 mg Filmdragerad tablettJanssen-Cilag International NV
- SpainYUVANCI 10 MG/20 MG COMPRIMIDOS RECUBIERTOS CON PELICULAJanssen-Cilag International N.V
- IrelandYuvanci 10 mg/20 mg film-coated tabletsJanssen Pharmaceutica NV
- IcelandYuvanciJanssen-Cilag International NV*
- NetherlandsYuvanci 10 mg/20 mg filmomhulde tablettenJanssen-Cilag International NV
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Yuvanci
- Liechtenstein · Yuvanci
- Norway · Yuvanci
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/1a5db62d-c942-4988-a35a-f6221c47d090 GET /v1/drugs/1a5db62d-c942-4988-a35a-f6221c47d090?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "ORAL",
"source": "ndc",
"strength": "10; 20",
"substance": "MACITENTAN; TADALAFIL",
"productndc": "66215-812",
"dosage_form": "TABLET, FILM COATED",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1",
"application_number": "NDA218490",
"marketing_category": "NDA"
}See everything about macitentan and tadalafil.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.