United States· US:0078-0566_79d3253f-e1e3-428f-8dd4-4f2fe76faa15
Afinitor
A medicinal product containing everolimus, registered in United States by Novartis Pharmaceuticals Corporation.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- everolimus
- Manufacturer
- Novartis Pharmaceuticals Corporation
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 12, 2026
Packs & prices · 1
- ndc11007805665128 BLISTER PACK in 1 CARTON (0078-0566-51) / 1 TABLET in 1 BLISTER PACK (0078-0566-61)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Everolimus in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaAFINITORNovartis Europharm Limited, Dublin
- NetherlandsAfinitor 5 mg, tablettenNovartis Europharm Limited
- SpainAFINITOR 5 MG COMPRIMIDOSNovartis Europharm Limited
- FinlandAfinitorNovartis Europharm Limited
- FranceAFINITOR 5 mg, comprimésNOVARTIS EUROPHARM (IRLANDE)
- United KingdomAfinitor 5mg tabletsOriginalis B.V.
- SwedenAfinitor 5 mg TablettNovartis Europharm Limited
- PolandAfinitorNovartis Europharm Limited
Authorised across Europe · EMA
The same active substance is authorised in 31 EEA countries. Names it is sold under:
- Austria · Certican, Everolimus Ethypharm
- Belgium · Certican, Everolimus Eg
- Bulgaria · Еверолимус Крка, Еверолимус Майлан
- Cyprus · Certican, Everolimus Pharmazac
- Czechia · Certican, Everolimus Accord
- Germany · Certican, Everofin
- Denmark · Certican, Everolimus Krka
- Estonia · Certican, Everolimus Krka
- Spain · Certican, Everolimus Accord
- Finland · Aderolio, Certican
- France · Certican, Everolimus Arrow
- United Kingdom (Northern Ireland) · Aderolio, Aderolio 250 Mcg Tablets
- Greece · Certican, Everolimus Faran
- Croatia · Certican, Everolimus Krka
- Hungary · Certican, Everolimus Accord
- Ireland · Certican, Everolimus Tad
- Iceland · Afinitor, Certican
- Italy · Certican, Everolimus Accord
- Liechtenstein · Afinitor, Votubia
- Lithuania · Certican, Everolimus Norameda
- Luxembourg · Certican, Everolimus Eg
- Latvia · Certican, Everolimus Norameda
- Malta · Certican, Everolimus Ascend
- Netherlands · Certican, Certican Dispers
- Norway · Afinitor, Certican
- Poland · Aderolio, Certican
- Portugal · Certican, Everolimus Ethypharm
- Romania · Certican, Everolimus Accord
- Sweden · Certican, Everolimus Avansor
- Slovenia · Certican, Everolimus Krka
- Slovakia · Certican, Everolimus Accord
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/d8e93c7b-68ee-4860-83ef-2a4aa2d75741 GET /v1/drugs/d8e93c7b-68ee-4860-83ef-2a4aa2d75741?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.
{
"route": "ORAL",
"livertox": {
"summary": null,
"livertox_id": null,
"hepatotoxicity_score": 5
},
"productid": "0078-0566_79d3253f-e1e3-428f-8dd4-4f2fe76faa15",
"productndc": "0078-0566",
"dosage_form": "TABLET",
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "EVEROLIMUS",
"proprietary_name": "Afinitor",
"active_ingred_unit": "mg/1",
"application_number": "NDA022334",
"marketing_category": "NDA",
"nonproprietary_name": "everolimus",
"start_marketing_date": "20090331",
"active_numerator_strength": "5"
}See everything about everolimus.
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.