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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

  • ndc11
    8049180123
    1 BOTTLE in 1 CARTON (80491-8012-3) / 30 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    8049180128
    1 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

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