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United States · US · US:68516-3212_d13b6d66-7106-4a34-8521-1cf16d2578b9

Profilnine

SPL

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

Identification

ManufacturerGRIFOLS USA, LLC
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6851632122
    1 KIT in 1 CARTON (68516-3212-2) * 10 mL in 1 VIAL (68516-3206-2) * 10 mL in 1 VIAL, GLASS (76297-002-12)

Annotations

DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": "INTRAVENOUS",
  "spl_meta": {
    "79821042-86a5-4a64-b621-76de0a0bbab2": {
      "match": "brand_token",
      "title": "PROFILNINE (FACTOR IX COMPLEX) KIT [GRIFOLS USA, LLC]",
      "spl_version": "33",
      "published_date": "2026-04-10"
    }
  },
  "productid": "68516-3212_d13b6d66-7106-4a34-8521-1cf16d2578b9",
  "productndc": "68516-3212",
  "dosage_form": "KIT",
  "dea_schedule": null,
  "product_type": "PLASMA DERIVATIVE",
  "substance_name": null,
  "proprietary_name": "Profilnine",
  "active_ingred_unit": null,
  "application_number": "BLA102476",
  "marketing_category": "BLA",
  "nonproprietary_name": "factor ix complex",
  "start_marketing_date": "19810720",
  "active_numerator_strength": null
}

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