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United States · US · US:0597-7705_31184b4e-682f-45ba-9e4f-332bc1df45b8

SPEVIGO

UNIISPLATC L04AC22

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

Identification

ManufacturerBoehringer Ingelheim Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeL04AC22
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0597770541
    1 SYRINGE in 1 CARTON (0597-7705-41) / 300 mL in 1 SYRINGE (0597-7705-38)
  • ndc11
    0597770572
    2 SYRINGE in 1 CARTON (0597-7705-72) / 300 mL in 1 SYRINGE (0597-7705-38)

Annotations

UNII (FDA Substance ID)
5IB2J79MCX
SPESOLIMAB
RxCUI 2610417
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "5IB2J79MCX",
    "rxcui": "2610417",
    "inchikey": null,
    "display_name": "SPESOLIMAB",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "78a4f7eb-8d34-4467-8d40-74ed24323806": {
      "match": "brand_token",
      "title": "SPEVIGO (SPESOLIMAB) INJECTION [LEO PHARMA INC.]",
      "spl_version": "2",
      "published_date": "2026-03-19"
    }
  },
  "productid": "0597-7705_31184b4e-682f-45ba-9e4f-332bc1df45b8",
  "productndc": "0597-7705",
  "dosage_form": "INJECTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SPESOLIMAB",
  "proprietary_name": "SPEVIGO",
  "active_ingred_unit": "mg/2mL",
  "application_number": "BLA761244",
  "marketing_category": "BLA",
  "nonproprietary_name": "spesolimab-sbzo",
  "start_marketing_date": "20250528",
  "active_numerator_strength": "300"
}

Related drugs

Other records sharing ATC code L04AC22.

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