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United States · US · US:80491-8012_68b78342-ced1-436d-b591-bb14e1a9a2f7
TRYVIO
Orange BookUNIISPLATC C02KN01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerIdorsia Pharmaceuticals Ltd
CountryUS (United States)
ATC codeC02KN01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1180491801231 BOTTLE in 1 CARTON (80491-8012-3) / 30 TABLET, FILM COATED in 1 BOTTLE
- ndc1180491801281 BLISTER PACK in 1 CARTON (80491-8012-8) / 10 TABLET, FILM COATED in 1 BLISTER PACK (80491-8012-7)
Annotations
UNII (FDA Substance ID)
MZI81HV01P
APROCITENTAN
Orange Book
N217686
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "MZI81HV01P",
"rxcui": null,
"inchikey": "DKULOVKANLVDEA-UHFFFAOYSA-N",
"display_name": "APROCITENTAN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"dfe7a2ee-612c-4aba-834a-d68e6b59a0a6": {
"match": "brand_token",
"title": "TRYVIO (APROCITENTAN) TABLET, FILM COATED [IDORSIA PHARMACEUTICALS LTD]",
"spl_version": "7",
"published_date": "2026-02-10"
}
},
"productid": "80491-8012_68b78342-ced1-436d-b591-bb14e1a9a2f7",
"productndc": "80491-8012",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "217686",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "12.5MG",
"product_no": "001",
"approval_date": "Mar 19, 2024"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "APROCITENTAN",
"proprietary_name": "TRYVIO",
"active_ingred_unit": "mg/1",
"application_number": "NDA217686",
"marketing_category": "NDA",
"nonproprietary_name": "Aprocitentan",
"start_marketing_date": "20240320",
"active_numerator_strength": "12.5"
}Related drugs
Other records sharing ATC code C02KN01.
- PLJeraygoIdorsia Pharmaceuticals Deutschland GmbH
- PLJeraygoIdorsia Pharmaceuticals Deutschland GmbH
- CZJERAYGOIdorsia Pharmaceuticals Deutschland GmbH, Lörrach
- ISJERAYGOIdorsia Pharmaceuticals Deutschland GmbH
- DKJERAYGOIdorsia Pharmaceuticals Deutschland GmbH
- DKJERAYGOIdorsia Pharmaceuticals Deutschland GmbH
- ISJERAYGOIdorsia Pharmaceuticals Deutschland GmbH
- CZJERAYGOIdorsia Pharmaceuticals Deutschland GmbH, Lörrach
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