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United States· US:72694-728_a5229004-7c72-421b-a4ea-2830ee872d20

VORANIGO

A vorasidenib product containing vorasidenib, registered in United States by Servier Pharmaceuticals LLC. The same ATC class is registered in 12 of our 19 countries.

ATC L01XM04Orange BookUS 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…normalisedVORANIGOATCL01XM04REGISTER NO.US:72694-728_a5229004…PACKS LISTED1CHECKEDSeptember 12, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about vorasidenibAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Vorasidenib is registered in 12 of 19 countries.

Countries holding a registration under ATC L01XM04 (vorasidenib), each read from that country’s own register.

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

Vorasidenib · ATC L01XM04

12 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Spainprice
  • 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
vorasidenib
Manufacturer
Servier Pharmaceuticals LLC
Country
United States (US)
ATC code
L01XM04
ATC class
Vorasidenib
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 12, 2026

Packs & prices · 1

  • ndc11
    7269472840
    1 BOTTLE in 1 CARTON (72694-728-40) / 30 TABLET, FILM COATED in 1 BOTTLE

Regulatory notes

UNII (FDA substance ID)
789Q85GA8P
VORASIDENIB
Orange Book
N218784
DailyMed SPL labels
1 version tracked

Same medicine, other countries

Vorasidenib in 9 other countries

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

All vorasidenib products

Authorised across Europe · EMA

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

  • Iceland · Voranigo
  • Liechtenstein · Voranigo
  • Norway · Voranigo

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/946f9695-95dc-4e61-b316-692bfabedfee
GET /v1/drugs/946f9695-95dc-4e61-b316-692bfabedfee?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": "789Q85GA8P",
    "rxcui": null,
    "inchikey": "QCZAWDGAVJMPTA-RNFRBKRXSA-N",
    "display_name": "VORASIDENIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 5
  },
  "spl_meta": {
    "31405fee-55b7-4857-987e-2724ee76be84": {
      "match": "brand_token",
      "title": "VORANIGO (VORASIDENIB) TABLET, FILM COATED [SERVIER PHARMACEUTICALS LLC]",
      "spl_version": "4",
      "published_date": "2025-04-10"
    }
  },
  "productid": "72694-728_a5229004-7c72-421b-a4ea-2830ee872d20",
  "productndc": "72694-728",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "218784",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Aug 6, 2024"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "40MG",
        "product_no": "002",
        "approval_date": "Aug 6, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VORASIDENIB",
  "proprietary_name": "VORANIGO",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA218784",
  "marketing_category": "NDA",
  "nonproprietary_name": "vorasidenib",
  "start_marketing_date": "20240807",
  "active_numerator_strength": "40"
}
API referenceMCP serverPlans

See everything about vorasidenib.

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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