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.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
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
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
- ndc11605054791110 TABLET in 1 CARTON (60505-4791-1)
- ndc1160505479144 TABLET in 1 CARTON (60505-4791-4)
- ndc1160505479155 TABLET in 1 CARTON (60505-4791-5)
- ndc1160505479166 TABLET in 1 CARTON (60505-4791-6)
- ndc1160505479177 TABLET in 1 CARTON (60505-4791-7)
- ndc1160505479188 TABLET in 1 CARTON (60505-4791-8)
- ndc1160505479199 TABLET in 1 CARTON (60505-4791-9)
Regulatory notes
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.
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.
- CzechiaMAVENCLADMerck Europe B.V., Amsterdam
- FinlandMAVENCLADMerck Europe B.V.
- SwitzerlandMavenclad 10 mg, TablettenMerck (Schweiz) AG
- NorwayMavencladAbacus Medicine A/S
- IcelandMavencladMerck Europe B.V.*
- NetherlandsMavenclad 10 mg tablettenMerck Europe B.V.
- PolandMavencladMerck Europe B.V.
- SwedenMAVENCLAD 10 mg TablettMerck Europe B.V.
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.