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United States · US · US:25682-046_cd0113b0-d5d6-4b03-9f6f-4d80bdcb71fe

Voydeya

Orange BookSPL

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

Identification

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

Packs · 1

  • ndc11
    2568204692
    1 KIT in 1 CARTON (25682-046-92) * 90 TABLET, FILM COATED in 1 BOTTLE (25682-040-90) * 90 TABLET, FILM COATED in 1 BOTTLE (25682-043-90)

Annotations

Orange Book
N218037
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "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": "25682-046_cd0113b0-d5d6-4b03-9f6f-4d80bdcb71fe",
  "productndc": "25682-046",
  "dosage_form": "KIT",
  "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": null,
  "proprietary_name": "Voydeya",
  "active_ingred_unit": null,
  "application_number": "NDA218037",
  "marketing_category": "NDA",
  "nonproprietary_name": "Danicopan",
  "start_marketing_date": "20240329",
  "active_numerator_strength": null
}

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