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United States· US:0597-0620_31184b4e-682f-45ba-9e4f-332bc1df45b8

SPEVIGO

A spesolimab product containing spesolimab-sbzo, registered in United States by Boehringer Ingelheim Pharmaceuticals, Inc.. The same ATC class is registered in 14 of our 19 countries.

ATC L04AC22US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedSPEVIGOATCL04AC22REGISTER NO.US:0597-0620_31184b4e…PACKS LISTED1CHECKEDSeptember 12, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about spesolimab-sbzoAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Spesolimab is registered in 14 of 19 countries.

Countries holding a registration under ATC L04AC22 (spesolimab), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 9 of them publish a price we can compare per daily dose
Search spesolimab products by name

Spesolimab · ATC L04AC22

14 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
spesolimab-sbzo
Manufacturer
Boehringer Ingelheim Pharmaceuticals, Inc.
Country
United States (US)
ATC code
L04AC22
ATC class
Spesolimab
Defined daily dose
0.9 g, P
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 12, 2026

Packs & prices · 1

  • ndc11
    0597062020
    2 SYRINGE in 1 CARTON (0597-0620-20) / 150 mL in 1 SYRINGE (0597-0620-10)

Regulatory notes

UNII (FDA substance ID)
5IB2J79MCX
SPESOLIMAB
RxCUI 2610417
DailyMed SPL labels
1 version tracked

Same medicine, other countries

Spesolimab in 15 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All spesolimab products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Iceland · Spevigo
  • Liechtenstein · Spevigo
  • Norway · Spevigo

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/6e26517f-e3e3-4620-800f-432e8ee33146
GET /v1/drugs/6e26517f-e3e3-4620-800f-432e8ee33146?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "unii": {
    "unii": "5IB2J79MCX",
    "rxcui": "2610417",
    "inchikey": null,
    "display_name": "SPESOLIMAB",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": null
  },
  "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": "0597-0620_31184b4e-682f-45ba-9e4f-332bc1df45b8",
  "productndc": "0597-0620",
  "dosage_form": "INJECTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SPESOLIMAB",
  "proprietary_name": "SPEVIGO",
  "active_ingred_unit": "mg/mL",
  "application_number": "BLA761244",
  "marketing_category": "BLA",
  "nonproprietary_name": "spesolimab-sbzo",
  "start_marketing_date": "20240318",
  "active_numerator_strength": "150"
}
API referenceMCP serverPlans

See everything about spesolimab.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.

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