ALPROLIX

SPL

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

Identification

ManufacturerBioverativ Therapeutics Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7110491101
1 KIT in 1 KIT (71104-911-01) * 5 mL in 1 VIAL (71104-953-09) * 5 mL in 1 VIAL (71104-045-01)

Annotations

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "2fb3fb92-379d-4683-80d6-b06c0a7dc063": {
      "match": "brand_token",
      "title": "ALPROLIX (COAGULATION FACTOR IX (RECOMBINANT), FC FUSION PROTEIN) KIT [BIOVERATIV THERAPEUTICS INC.]",
      "spl_version": "12",
      "published_date": "2024-05-17"
    }
  },
  "productid": "71104-911_24887518-9870-451a-9db5-b03dc5571c19",
  "productndc": "71104-911",
  "dosage_form": "KIT",
  "dea_schedule": null,
  "product_type": "PLASMA DERIVATIVE",
  "substance_name": null,
  "proprietary_name": "ALPROLIX",
  "active_ingred_unit": null,
  "application_number": "BLA125444",
  "marketing_category": "BLA",
  "nonproprietary_name": "Coagulation Factor IX (Recombinant), Fc Fusion Protein",
  "start_marketing_date": "20140505",
  "active_numerator_strength": null
}

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