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United States · US · US:82705-002_13fee518-576f-45f0-885a-b6b537128dde

EPKINLY

UNIISPLATC L01FX27

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

Identification

ManufacturerGenmab US, Inc.
CountryUS (United States)
ATC codeL01FX27
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8270500201
    1 VIAL, GLASS in 1 CARTON (82705-002-01) / .8 mL in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)
D6OMY2L0WA
EPCORITAMAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "D6OMY2L0WA",
    "rxcui": null,
    "inchikey": null,
    "display_name": "EPCORITAMAB",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "d7836711-b677-412d-bf2d-0f7c8444103a": {
      "match": "brand_token",
      "title": "EPKINLY (EPCORITAMAB-BYSP) INJECTION, SOLUTION [GENMAB US, INC.]",
      "spl_version": "10",
      "published_date": "2026-04-06"
    }
  },
  "productid": "82705-002_13fee518-576f-45f0-885a-b6b537128dde",
  "productndc": "82705-002",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EPCORITAMAB",
  "proprietary_name": "EPKINLY",
  "active_ingred_unit": "mg/.8mL",
  "application_number": "BLA761324",
  "marketing_category": "BLA",
  "nonproprietary_name": "epcoritamab-bysp",
  "start_marketing_date": "20230519",
  "active_numerator_strength": "4"
}

Related drugs

Other records sharing ATC code L01FX27.

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