United States· US:60505-4791_f29f726e-f858-7aff-d874-b322d5ca860c

Cladribine

A cladribine product containing cladribine, registered in United States by Apotex Corp.. The same ATC class is registered in 14 of our 19 countries.

ATC L01BB04Orange 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…normalisedCladribineATCL01BB04REGISTER NO.US:60505-4791_f29f726…PACKS LISTED7CHECKEDSeptember 12, 2026

Where it is registered

Cladribine is registered in 14 of 19 countries.

Countries holding a registration under ATC L01BB04 (cladribine), 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

Cladribine · ATC L01BB04

14 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Italyprice
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • 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
Cladribine
Manufacturer
Apotex Corp.
Country
United States (US)
ATC code
L01BB04
ATC class
Cladribine
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 12, 2026

Packs & prices · 7

  • ndc11
    6050547911
    10 TABLET in 1 CARTON (60505-4791-1)
  • ndc11
    6050547914
    4 TABLET in 1 CARTON (60505-4791-4)
  • ndc11
    6050547915
    5 TABLET in 1 CARTON (60505-4791-5)
  • ndc11
    6050547916
    6 TABLET in 1 CARTON (60505-4791-6)
  • ndc11
    6050547917
    7 TABLET in 1 CARTON (60505-4791-7)
  • ndc11
    6050547918
    8 TABLET in 1 CARTON (60505-4791-8)
  • ndc11
    6050547919
    9 TABLET in 1 CARTON (60505-4791-9)

Regulatory notes

UNII (FDA substance ID)
47M74X9YT5
CLADRIBINE
RxCUI 44157
Orange Book
A218425
AB
DailyMed SPL labels
1 version tracked

Interactions

409 interactions on record for cladribine.

Graded by severity as the source publishes them — 326 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

Cladribine · interactions on record

409 records

  • 326 severe
  • 79 moderate
  • 4 info

Most severe, free to view

  • PrednisoloneA07EA01severe
  • HydrocortisoneA07EA02severe
  • PrednisoneA07EA03severe
  • BetamethasoneA07EA04severe
  • 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

Cladribine in 16 other countries

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

All cladribine products

Authorised across Europe · EMA

The same active substance is authorised in 23 EEA countries. Names it is sold under:

  • Austria · Leuject
  • Belgium · Leustatin
  • Bulgaria · Леуджект
  • Czechia · Leuject
  • Germany · Leustatin
  • Spain · Leustatin
  • Finland · Leuject
  • France · Leustatine
  • United Kingdom (Northern Ireland) · Cladribine Zentiva, Leustat
  • Greece · Leustatin
  • Croatia · Leuject
  • Hungary · Leuject
  • Iceland · Mavenclad
  • Italy · Leustatin
  • Liechtenstein · Mavenclad
  • Luxembourg · Leustatin
  • Netherlands · Leustatin
  • Norway · Leuject, Mavenclad
  • Poland · Biodribin, Leuject
  • Portugal · Cladribina Generis, Leustatin
  • Romania · Leuject
  • Sweden · Leuject
  • Slovenia · Leuject

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/d9c10091-e3f3-4204-b642-2b9e3c426198
GET /v1/drugs/d9c10091-e3f3-4204-b642-2b9e3c426198?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": "47M74X9YT5",
    "rxcui": "44157",
    "inchikey": "PTOAARAWEBMLNO-KVQBGUIXSA-N",
    "display_name": "CLADRIBINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 5
  },
  "spl_meta": {
    "e0b363cb-db83-44d6-89d0-1f7176be7459": {
      "match": "brand_token",
      "title": "CLADRIBINE TABLET [SANDOZ INC.]",
      "spl_version": "1",
      "published_date": "2026-04-24"
    }
  },
  "productid": "60505-4791_f29f726e-f858-7aff-d874-b322d5ca860c",
  "productndc": "60505-4791",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "218425",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Nov 24, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLADRIBINE",
  "proprietary_name": "Cladribine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA218425",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cladribine",
  "start_marketing_date": "20251125",
  "active_numerator_strength": "10"
}

See everything about cladribine.

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.