BeneFIX

SPL

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

Identification

ManufacturerWyeth BioPharma Division of Wyeth Pharmaceuticals LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5839463403
1 KIT in 1 CARTON (58394-634-03) * 5 mL in 1 SYRINGE (58394-041-11) * 1 mL in 1 PACKET (0069-1111-01) * 5 mL in 1 VIAL, SINGLE-USE (58394-134-03)

Annotations

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "85faa5bc-cee5-4ef1-8d80-bdbcb7eba1e4": {
      "match": "brand_token",
      "title": "BENEFIX (COAGULATION FACTOR IX (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS LLC]",
      "spl_version": "45",
      "published_date": "2025-02-27"
    }
  },
  "productid": "58394-634_3b0657cb-0070-4c64-b72c-2518178805e7",
  "productndc": "58394-634",
  "dosage_form": "KIT",
  "dea_schedule": null,
  "product_type": "PLASMA DERIVATIVE",
  "substance_name": null,
  "proprietary_name": "BeneFIX",
  "active_ingred_unit": null,
  "application_number": "BLA103677",
  "marketing_category": "BLA",
  "nonproprietary_name": "coagulation factor ix (recombinant)",
  "start_marketing_date": "19970201",
  "active_numerator_strength": null
}

Access this data programmatically

Query BeneFIX and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs