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United States Β· US Β· US:0169-7901_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 codeβ€”
Dispensingβ€”
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs Β· 2

  • ndc11
    0169790101
    1 KIT in 1 KIT (0169-7901-01) * 4 mL in 1 VIAL, GLASS (0169-7911-90) * 4 mL in 1 SYRINGE, GLASS (0169-7009-98) * 4 mL in 1 VIAL, GLASS (0169-7911-11)
  • ndc11
    0169790197
    1 KIT in 1 KIT (0169-7901-97) * 4 mL in 1 VIAL, GLASS (0169-7911-90) * 4 mL in 1 SYRINGE, GLASS (0169-7009-98) * 4 mL in 1 VIAL, GLASS (0169-7911-11)

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": "0169-7901_4d658384-07d9-471f-8b15-16b8cec36765",
  "productndc": "0169-7901",
  "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": "20171201",
  "active_numerator_strength": null
}

Access this data programmatically

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REBINYN (US) β€” Drug Database