Koate

SPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerKEDRION BIOPHARMA, INC.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7612567650
1 KIT in 1 CARTON (76125-676-50) * 10 mL in 1 VIAL, GLASS (76125-673-51) * 10 mL in 1 VIAL, GLASS (13533-000-05)

Annotations

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": "INTRAVENOUS",
  "spl_meta": {
    "865df1e2-b4d1-dbf5-2899-a9c02df4d122": {
      "match": "brand_token",
      "title": "KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT KOATE (ANTIHEMOPHILIC FACTOR (HUMAN)) KIT [KEDRION BIOPHARMA, INC.]",
      "spl_version": "10",
      "published_date": "2023-12-28"
    }
  },
  "productid": "76125-676_703c908c-e602-4a36-9b58-1ba7206d18ea",
  "productndc": "76125-676",
  "dosage_form": "KIT",
  "dea_schedule": null,
  "product_type": "PLASMA DERIVATIVE",
  "substance_name": null,
  "proprietary_name": "Koate",
  "active_ingred_unit": null,
  "application_number": "BLA101130",
  "marketing_category": "BLA",
  "nonproprietary_name": "ANTIHEMOPHILIC FACTOR (HUMAN)",
  "start_marketing_date": "19990520",
  "active_numerator_strength": null
}

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