AlphaNine

SPL

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

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
6851636072
1 KIT in 1 CARTON (68516-3607-2) * 10 mL in 1 VIAL (68516-3604-2) * 10 mL in 1 VIAL, SINGLE-DOSE (68516-1002-2)

Annotations

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": "INTRAVENOUS",
  "spl_meta": {
    "3e99052d-4442-4283-8915-c9a796c77008": {
      "match": "brand_token",
      "title": "ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC]",
      "spl_version": "25",
      "published_date": "2025-06-09"
    }
  },
  "productid": "68516-3607_8b01a6ae-2639-401f-9b03-45350a21e166",
  "productndc": "68516-3607",
  "dosage_form": "KIT",
  "dea_schedule": null,
  "product_type": "PLASMA DERIVATIVE",
  "substance_name": null,
  "proprietary_name": "AlphaNine",
  "active_ingred_unit": null,
  "application_number": "BLA103249",
  "marketing_category": "BLA",
  "nonproprietary_name": "COAGULATION FACTOR IX (HUMAN)",
  "start_marketing_date": "19901231",
  "active_numerator_strength": null
}

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