United States· US:72485-210_ae29e15b-df07-403f-8d07-f99e3ce501e7

Busulfan

A busulfan product containing busulfan, registered in United States by Armas Pharmaceuticals Inc.. The same ATC class is registered in 15 of our 19 countries.

In shortageATC L01AB01Orange 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…normalisedBusulfanATCL01AB01REGISTER NO.US:72485-210_ae29e15b…PACKS LISTED1CHECKEDSeptember 12, 2026

Where it is registered

Busulfan is registered in 15 of 19 countries.

Countries holding a registration under ATC L01AB01 (busulfan), 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

Busulfan · ATC L01AB01

15 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Germany
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • Sweden
  • 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
Busulfan
Manufacturer
Armas Pharmaceuticals Inc.
Country
United States (US)
ATC code
L01AB01
ATC class
Busulfan
Defined daily dose
0.224 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
    7248521008
    8 VIAL, SINGLE-DOSE in 1 CARTON (72485-210-08) / 10 mL in 1 VIAL, SINGLE-DOSE (72485-210-01)

Regulatory notes

UNII (FDA substance ID)
G1LN9045DK
BUSULFAN
RxCUI 1828
Orange Book
A210931
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Busulfan Injection

Interactions

245 interactions on record for busulfan.

Graded by severity as the source publishes them — 34 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

Busulfan · interactions on record

245 records

  • 34 severe
  • 141 moderate
  • 16 minor
  • 54 info

Most severe, free to view

  • Nalidixic acidJ01MB02severe
  • MetronidazoleJ01XD01severe
  • ThiotepaL01AC01severe
  • CladribineL01BB04severe
  • 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

Busulfan in 14 other countries

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

All busulfan products

Authorised across Europe · EMA

The same active substance is authorised in 25 EEA countries. Names it is sold under:

  • Austria · Busulfan Accord, Myleran
  • Belgium · Myleran
  • Czechia · Myleran
  • Germany · Busulfan Accord, Busulfan Koanaa
  • Denmark · Busulfan Zentiva
  • Estonia · Myleran
  • Spain · Busulfano Accord, Busulfano Aspen
  • France · Busulfan Accord, Busulfan Koanaa
  • United Kingdom (Northern Ireland) · Busulfan Accord, Busulfan Aspen Pharma Trading Limited
  • Greece · Busulfan Bioars
  • Croatia · Busulfan Pliva
  • Hungary · Busulfan Accord, Busulfan Teva
  • Ireland · Myleran
  • Iceland · Busulfan Fresenius Kabi, Myleran
  • Italy · Busulfan Accord, Busulfan Tillomed
  • Liechtenstein · Busulfan Fresenius Kabi
  • Lithuania · Myleran
  • Luxembourg · Myleran
  • Netherlands · Busulfan Teva, Myleran
  • Norway · Busulfan Fresenius Kabi
  • Poland · Busulfan Accord, Busulfan Zentiva
  • Portugal · Bussulfano Accord, Myleran
  • Romania · Busulfan Accord, Myleran
  • Sweden · Busulfan Zentiva, Myleran
  • Slovakia · Myleran

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/abbfde15-ef97-426f-851f-7ee156e00d7f
GET /v1/drugs/abbfde15-ef97-426f-851f-7ee156e00d7f?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": "G1LN9045DK",
    "rxcui": "1828",
    "inchikey": "COVZYZSDYWQREU-UHFFFAOYSA-N",
    "display_name": "BUSULFAN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 1
  },
  "spl_meta": {
    "06883ac0-4b2a-4f26-89bf-512d37b9ba7f": {
      "match": "brand_token",
      "title": "BUSULFAN INJECTION, SOLUTION [EUGIA US LLC]",
      "spl_version": "1",
      "published_date": "2024-06-28"
    }
  },
  "productid": "72485-210_ae29e15b-df07-403f-8d07-f99e3ce501e7",
  "productndc": "72485-210",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "210931",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "6MG/ML",
        "product_no": "001",
        "approval_date": "Apr 18, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUSULFAN",
  "shortage_reason": "Busulfan Injection",
  "shortage_status": "current",
  "proprietary_name": "Busulfan",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA210931",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Busulfan",
  "start_marketing_date": "20190601",
  "active_numerator_strength": "6"
}

See everything about busulfan.

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.