United States· US:59572-740_6981b224-73db-4a2a-b901-ed7e5bffd5ea

ONUREG

A azacitidine product containing azacitidine, registered in United States by Celgene Corporation. The same ATC class is registered in 18 of our 19 countries.

In shortageATC L01BC07Orange 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…normalisedONUREGATCL01BC07REGISTER NO.US:59572-740_6981b224…PACKS LISTED2CHECKEDSeptember 12, 2026

Where it is registered

Azacitidine is registered in 18 of 19 countries.

Countries holding a registration under ATC L01BC07 (azacitidine), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 10 of them publish a price we can compare per daily dose

Azacitidine · ATC L01BC07

18 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Germany
  • Icelandprice
  • Ireland
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • Spainprice
  • Sweden
  • 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.

Price per daily dose

What a daily dose of azacitidine costs, country by country.

Normalised to the WHO defined daily dose (0.15 g), the median price runs from $0.69 in France to $470.17 in Switzerland — a ×683 gap.

  • 3 markets with a comparable price for this class
  • Public list prices, converted to USD at the rate date shown

Azacitidine · price per daily dose (0.15 g)

USD · FX 28 Sept 2026

  • CH Switzerland$470.17
  • CZ Czechia$4.72
  • FR France$0.69
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
azacitidine
Manufacturer
Celgene Corporation
Country
United States (US)
ATC code
L01BC07
ATC class
Azacitidine
Defined daily dose
0.15 g, O
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 12, 2026

Packs & prices · 2

  • ndc11
    5957274007
    7 TABLET, FILM COATED in 1 BLISTER PACK (59572-740-07)
  • ndc11
    5957274014
    14 TABLET, FILM COATED in 1 BOTTLE (59572-740-14)

Regulatory notes

UNII (FDA substance ID)
M801H13NRU
AZACITIDINE
RxCUI 1251
Orange Book
N214120
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Azacitidine Injection

Interactions

75 interactions on record for azacitidine.

Graded by severity as the source publishes them — 30 severe. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan

Azacitidine · interactions on record

75 records

  • 30 severe
  • 45 moderate

Most severe, free to view

  • CladribineL01BB04severe
  • Talimogene laherparepvecL01XL02severe
  • Talimogen laherparepvecL01XX51severe
  • LeflunomidL04AA13severe
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Azacitidine in 15 other countries

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

All azacitidine products

Authorised across Europe · EMA

The same active substance is authorised in 30 EEA countries. Names it is sold under:

  • Austria · Azacitidin Hikma, Azacitidin Sandoz
  • Belgium · Azacitidin Sandoz, Azacitidine Eugia
  • Bulgaria · Азацитидин, Азацитидин Ромфарм
  • Cyprus · Azacitidine Koanaa 25 Mg/Ml, Azacitidine Sandoz
  • Czechia · Azacitidin Sandoz, Azacitidine Rompharm
  • Germany · Azacitidin, Azacitidin Aqvida
  • Denmark · Azacitidin "stada Arzneimittel Ag", Azacitidin Adalvo
  • Estonia · Azacitidine Auxilia
  • Spain · Azacitidina Dr. Reddys, Azacitidina Eugia
  • Finland · Azacitidine Hikma, Azacitidine Sandoz
  • France · Azacitidine Arrow, Azacitidine Biogaran
  • United Kingdom (Northern Ireland) · Azacitidine Amarox, Azacitidine Eugia (Uk)
  • Greece · Azacitidine Sandoz, Azacitidine Stada
  • Croatia · Azacitidin Pharmascience, Azacitidin Sandoz
  • Hungary · Azacitidin Aliud, Azacitidin Sandoz
  • Ireland · Azacitdine Clonmel, Azacitidine Clonmel
  • Iceland · Azacitidine Accord, Azacitidine Glenmark
  • Italy · Azacitidina Aurobindo, Azacitidina Eg Stada
  • Liechtenstein · Azacitidine Accord, Azacitidine Kabi
  • Lithuania · Azacitidine Auxilia, Azacitidine Icg Farma
  • Luxembourg · Azacitidine Azacitidine Eg 25 Mg/Ml Poudre Pour Suspension Injectable, Azacitidine Eurogenerics
  • Malta · Azacitidine Adalvo, Azacitidine Lotus
  • Netherlands · Azacitidine, Azacitidine Cf
  • Norway · Azacitidin Sun, Azacitidin Tillomed
  • Poland · Azacitidine Eugia, Azacitidine Msn
  • Portugal · Azacitidina Eugia, Azacitidina Hikma
  • Romania · Azacitidină Aqvida, Azacitidină Dr. Reddy’s
  • Sweden · Azacitidine Azacitidine Lotus Pharma, Azacitidine Hikma
  • Slovenia · Azacitidin Sandoz, Azacitidin Stada
  • Slovakia · Azacitidine Glenmark, Azacitidine Sandoz

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/15dbb281-5d59-4c69-962d-510d922dfe0e
GET /v1/drugs/15dbb281-5d59-4c69-962d-510d922dfe0e?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": "M801H13NRU",
    "rxcui": "1251",
    "inchikey": "NMUSYJAQQFHJEW-KVTDHHQDSA-N",
    "display_name": "AZACITIDINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 5
  },
  "spl_meta": {
    "0e95e33f-8aba-4f19-b332-2416580d358b": {
      "match": "brand_token",
      "title": "ONUREG (AZACITIDINE) TABLET, FILM COATED [CELGENE CORPORATION]",
      "spl_version": "13",
      "published_date": "2026-04-17"
    }
  },
  "productid": "59572-740_6981b224-73db-4a2a-b901-ed7e5bffd5ea",
  "productndc": "59572-740",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "214120",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Sep 1, 2020"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Sep 1, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AZACITIDINE",
  "shortage_reason": "Azacitidine Injection",
  "shortage_status": "current",
  "proprietary_name": "ONUREG",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA214120",
  "marketing_category": "NDA",
  "nonproprietary_name": "azacitidine",
  "start_marketing_date": "20200901",
  "active_numerator_strength": "300"
}

See everything about azacitidine.

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.