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United States · US · US:25682-043_cd0113b0-d5d6-4b03-9f6f-4d80bdcb71fe

Voydeya

Orange BookUNIISPLATC L04AJ09

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAlexion Pharmaceuticals Inc.
CountryUS (United States)
ATC codeL04AJ09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2568204392
    2 BOTTLE in 1 CARTON (25682-043-92) / 90 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
JM8C1SFX0U
DANICOPAN
Orange Book
N218037
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "JM8C1SFX0U",
    "rxcui": null,
    "inchikey": "PIBARDGJJAGJAJ-NQIIRXRSSA-N",
    "display_name": "DANICOPAN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "ab8d1cbd-a28b-4d49-82ab-5c7460719ac7": {
      "match": "brand_token",
      "title": "VOYDEYA (DANICOPAN) TABLET, FILM COATED VOYDEYA (DANICOPAN) KIT [ALEXION PHARMACEUTICALS INC.]",
      "spl_version": "5",
      "published_date": "2026-05-20"
    }
  },
  "productid": "25682-043_cd0113b0-d5d6-4b03-9f6f-4d80bdcb71fe",
  "productndc": "25682-043",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "218037",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Mar 29, 2024"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Mar 29, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DANICOPAN",
  "proprietary_name": "Voydeya",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA218037",
  "marketing_category": "NDA",
  "nonproprietary_name": "Danicopan",
  "start_marketing_date": "20240329",
  "active_numerator_strength": "100"
}

Related drugs

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