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United States · US · US:0169-7903_4d658384-07d9-471f-8b15-16b8cec36765

REBINYN

SPL

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

Identification

ManufacturerNovo Nordisk
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0169790301
    1 KIT in 1 KIT (0169-7903-01) * 4 mL in 1 VIAL, GLASS (0169-7933-11) * 4 mL in 1 SYRINGE, GLASS (0169-7009-98)

Annotations

DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "0ea37235-35fd-410d-b8c4-40ba15fe1294": {
      "match": "brand_token",
      "title": "REBINYN (COAGULATION FACTOR IX RECOMBINANT, GLYCOPEGYLATED) KIT [NOVO NORDISK]",
      "spl_version": "9",
      "published_date": "2024-08-08"
    }
  },
  "productid": "0169-7903_4d658384-07d9-471f-8b15-16b8cec36765",
  "productndc": "0169-7903",
  "dosage_form": "KIT",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "REBINYN",
  "active_ingred_unit": null,
  "application_number": "BLA125611",
  "marketing_category": "BLA",
  "nonproprietary_name": "coagulation factor IX recombinant, GlycoPEGylated",
  "start_marketing_date": "20220811",
  "active_numerator_strength": null
}

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