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United States · US · US:58394-016_9b1ef7a8-35e5-4b97-9907-fc807d47e0fc

Xyntha

SPL

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

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
    5839401603
    1 KIT in 1 CARTON (58394-016-03) * 4 mL in 1 SYRINGE (58394-116-03) * 1 mL in 1 PACKET

Annotations

DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "25ea1c3c-14a2-ef11-302e-012bd683924f": {
      "match": "brand_token",
      "title": "XYNTHA (ANTIHEMOPHILIC FACTOR (RECOMBINANT)) KIT [WYETH BIOPHARMA DIVISION OF WYETH PHARMACEUTICALS LLC]",
      "spl_version": "35",
      "published_date": "2026-03-20"
    }
  },
  "productid": "58394-016_9b1ef7a8-35e5-4b97-9907-fc807d47e0fc",
  "productndc": "58394-016",
  "dosage_form": "KIT",
  "dea_schedule": null,
  "product_type": "PLASMA DERIVATIVE",
  "substance_name": null,
  "proprietary_name": "Xyntha",
  "active_ingred_unit": null,
  "application_number": "BLA125264",
  "marketing_category": "BLA",
  "nonproprietary_name": "antihemophilic factor (recombinant)",
  "start_marketing_date": "20100813",
  "active_numerator_strength": null
}

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