🇺🇸
United States · US · US:66215-812_32840e17-39b6-50b2-e063-6394a90a7a37
OPSYNVI
Orange BookUNIISPLATC C02KX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerActelion Pharmaceuticals US, Inc.
CountryUS (United States)
ATC codeC02KX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- 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
Annotations
UNII (FDA Substance ID)
Z9K9Y9WMVL
MACITENTAN
RxCUI 1442132
Orange Book
N218490
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "Z9K9Y9WMVL",
"rxcui": "1442132",
"inchikey": "JGCMEBMXRHSZKX-UHFFFAOYSA-N",
"display_name": "MACITENTAN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"6945b183-18d3-40de-afd1-c88e33cc1a63": {
"match": "brand_token",
"title": "OPSYNVI (MACITENTAN AND TADALAFIL) TABLET, FILM COATED [ACTELION PHARMACEUTICALS US, INC.]",
"spl_version": "3",
"published_date": "2025-04-14"
}
},
"productid": "66215-812_32840e17-39b6-50b2-e063-6394a90a7a37",
"productndc": "66215-812",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "218490",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "10MG;20MG",
"product_no": "001",
"approval_date": "Mar 22, 2024"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "10MG;40MG",
"product_no": "002",
"approval_date": "Mar 22, 2024"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MACITENTAN; TADALAFIL",
"proprietary_name": "OPSYNVI",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA218490",
"marketing_category": "NDA",
"nonproprietary_name": "macitentan and tadalafil",
"start_marketing_date": "20240322",
"active_numerator_strength": "10; 20"
}Related drugs
Other records sharing ATC code C02KX.
Access this data programmatically
Query OPSYNVI and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.