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United States · US · US:66658-523_58d52c0a-08fe-40f4-86ba-752dd079ec91

GAMIFANT

UNIISPLATC L04AG09

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

Identification

ManufacturerSwedish Orphan Biovitrum AB (publ)
CountryUS (United States)
ATC codeL04AG09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6665852301
    1 VIAL, SINGLE-USE in 1 CARTON (66658-523-01) / 4 mL in 1 VIAL, SINGLE-USE

Annotations

UNII (FDA Substance ID)
3S252O2Z4X
EMAPALUMAB
RxCUI 2104604
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "3S252O2Z4X",
    "rxcui": "2104604",
    "inchikey": null,
    "display_name": "EMAPALUMAB",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "a865e0ef-8685-4f69-8838-648c4f3bab47": {
      "match": "brand_token",
      "title": "GAMIFANT (EMAPALUMAB-LZSG) INJECTION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)]",
      "spl_version": "10",
      "published_date": "2026-03-31"
    }
  },
  "productid": "66658-523_58d52c0a-08fe-40f4-86ba-752dd079ec91",
  "productndc": "66658-523",
  "dosage_form": "INJECTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "EMAPALUMAB",
  "proprietary_name": "GAMIFANT",
  "active_ingred_unit": "mg/4mL",
  "application_number": "BLA761107",
  "marketing_category": "BLA",
  "nonproprietary_name": "emapalumab-lzsg",
  "start_marketing_date": "20230607",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code L04AG09.

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