United States· US:51672-4118_569a2172-d3a9-45c5-e063-6394a90a3955
Fluorouracil
A fluorouracil product containing fluorouracil, registered in United States by Sun Pharmaceutical Industries, Inc.. The same ATC class is registered in 3 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Fluorouracil is registered in 3 of 19 countries.
Countries holding a registration under ATC D11AF05 (fluorouracil), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 1 of them publish a price we can compare per daily dose
Fluorouracil · ATC D11AF05
3 / 19 countries
- Germany
- United Kingdom
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- FLUOROURACIL
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Country
- United States (US)
- ATC code
- D11AF05
- ATC class
- Fluorouracil
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 3
- ndc1151672-4118-2
- ndc1151672-4118-5
- ndc1151672-4118-6
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Fluorouracil in 17 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- NetherlandsEfudix crème, 50 mg/gBModesto B.V.
- SwitzerlandFluodix Leman 50 mg/g (5%), crèmeLeman SKL SA
- NorwayEfudix specificMeda
- PolandEfudixViatris Healthcare Sp. z o.o.
- United KingdomCarac 0.5% creamImported (United States)
- BelgiumEfflurak 40 mg/gPierre Fabre Médicament
- Czechia5-FLUOROURACIL EBEWEEBEWE Pharma Ges.m.b.H Nfg.KG, Unterach
- SwedenFluorouracil Accord 50 mg/ml Injektions-/infusionsvätska, lösningAccord Healthcare B.V.
Authorised across Europe · EMA
The same active substance is authorised in 30 EEA countries. Names it is sold under:
- Austria · 5-Fluorouracil Ebewe, Fluorouracil Accord
- Belgium · Efflurak, Efudix
- Bulgaria · 5-Флуороурацил “ебеве”, Флуороурацил Акорд
- Cyprus · Fluorouracil Accord
- Czechia · 5-Fluorouracil Ebewe, Fluorouracil Accord
- Germany · 5-Fu Medac, Benda-5 Fu
- Denmark · Fluorouracil Accord, Tolak
- Estonia · 5-Fluorouracil Ebewe, Fluorouracil Accord
- Spain · Fluorouracilo Accord, Tolak
- Finland · Fluorouracil Accord, Tolerak
- France · Efudix, Fluorouracile Accord
- United Kingdom (Northern Ireland) · Efudix, Fluorouracil Accord Healthcare
- Greece · Fluorouracil Anabiosis, Fluorouracil Opus
- Croatia · Fluorouracil Accord, Fluorouracil Sandoz
- Hungary · 5-Fluorouracil Ebewe, 5-Fluorouracil Sandoz
- Ireland · Efudix, Fluorouracil Accord
- Iceland · Flúoróúracíl Accord
- Italy · Fluorouracil Teva, Fluorouracile Ahcl
- Lithuania · Fluorouracil Accord
- Luxembourg · Efflurak, Efudix
- Latvia · Fluorouracil Accord
- Malta · Efudix
- Netherlands · Efudix, Fluorouracil Accord
- Norway · Fluorouracil Accord, Tolak
- Poland · 5-Fluorouracil Ebewe, Efudix
- Portugal · Efflurak, Fluorouracilo Accord
- Romania · 5-Fluorouracil, 5-Fluorouracil Ebewe
- Sweden · Fluorouracil Accord, Fluorouracil Teva
- Slovenia · 5-Fluorouracil Ebewe, Fluorouracil Accord
- Slovakia · Efudix, Fluorouracil 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/b09d6ccb-77b0-43e0-ac0a-7c1c85d2ce92 GET /v1/drugs/b09d6ccb-77b0-43e0-ac0a-7c1c85d2ce92?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": "TOPICAL",
"source": "ndc",
"strength": "50",
"substance": "FLUOROURACIL",
"productndc": "51672-4118",
"dosage_form": "CREAM",
"dea_schedule": null,
"strength_unit": "mg/g",
"application_number": "ANDA090368",
"marketing_category": "ANDA"
}See everything about fluorouracil.
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.