United States· US:65219-564_204bc630-60a8-46e7-8dc7-aa781b46ff2b
MITOMYCIN
A mitomycin product containing mitomycin, registered in United States by Fresenius Kabi USA, LLC. The same ATC class is registered in 17 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Mitomycin is registered in 17 of 19 countries.
Countries holding a registration under ATC L01DC03 (mitomycin), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 10 of them publish a price we can compare per daily dose
Mitomycin · ATC L01DC03
17 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Germany
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Spainprice
- Sweden
- Switzerlandprice
- United Kingdom
- United Statesprice
Price per daily dose
What a daily dose of mitomycin costs, country by country.
Normalised to the WHO defined daily dose (4.29 mg), so markets compare like for like.
- 1 market with a comparable price for this class
- Public list prices, converted to USD at the rate date shown
Mitomycin · price per daily dose (4.29 mg)
USD · FX 28 Sept 2026
- CH Switzerland$32.20
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- MITOMYCIN
- Manufacturer
- Fresenius Kabi USA, LLC
- Country
- United States (US)
- ATC code
- L01DC03
- ATC class
- Mitomycin
- Defined daily dose
- 4.29 mg, intravesikal
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc1165219564201 VIAL in 1 CARTON (65219-564-20) / 10 mL in 1 VIAL
- ndc1165219-564-20
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
193 interactions on record for mitomycin.
Graded by severity as the source publishes them — 31 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
Mitomycin · interactions on record
193 records
- 31 severe
- 101 moderate
- 15 minor
- 46 info
Most severe, free to view
- CladribineL01BB04severe
- FluorouracilL01BC02severe
- Talimogene laherparepvecL01XL02severe
- Talimogen laherparepvecL01XX51severe
- 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
Mitomycin in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumMitomycin Accord Healthcare 10 mgAccord Healthcare
- United KingdomMitocin 20mg powder and solvent for intravesical solution vialsVygoris Ltd
- GermanyMitemSubstipharm
- CzechiaMITOMYCIN ACCORDACCORD HEALTHCARE POLSKA Sp. z o.o., Varšava
- SpainMITOMICINA ACCORD 10 MG POLVO PARA SOLUCION INTRAVESICAL Y PARA SOLUCION INYECTABLE EFGAccord Healthcare S.L.U.
- FinlandMitomycin AccordAccord Healthcare B.V.
- NetherlandsMitomycine Accord 10 mg, poeder voor oplossing voor injectie / infusie of intravesicaal gebruikAccord Healthcare B.V.
- NorwayMitomycin medacMedac
Authorised across Europe · EMA
The same active substance is authorised in 26 EEA countries. Names it is sold under:
- Austria · Mitomycin Medac
- Belgium · Mitomycin Accord Healthcare, Mitomycin Medac
- Bulgaria · Митомицин Акорд
- Cyprus · Mitomycin Accord, Mitomycine Substipharm
- Czechia · Mitomycin Accord, Mitomycin Medac
- Germany · Mitem, Mito-Apogepha
- Denmark · Mitomycin Medac
- Estonia · Mitomycin Accord, Mitomycin Medac
- Spain · Mitomicina Accord, Mitomicina Aurovitas
- Finland · Mitomycin Accord, Mitomycin Medac
- France · Mitomycine Accord, Mitomycine Medac
- United Kingdom (Northern Ireland) · Mitocin, Mitomycin Accord Healthcare
- Ireland · Mitomycin Medac
- Iceland · Mitomycin Medac
- Italy · Mitomicina Accord, Mitomicina Medac
- Lithuania · Mitomycin Medac
- Latvia · Mitomycin Medac
- Malta · Mitomycine Substipharm
- Netherlands · Mitomycine Accord, Mitomycine Medac
- Norway · Mitomycin Medac, Mitomycin Substipharm
- Poland · Mitomycin Accord
- Portugal · Mitomicina Accord, Mitomicina Accord Healthcare
- Romania · Mitomicină Accord
- Sweden · Mitomycin Medac, Mitomycin Substipharm
- Slovenia · Mitomicin Accord, Mitomicin Medac
- Slovakia · Mitomycin Accord, Mitomycin Medac
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/e839aa4e-22cc-4f31-8e98-8642ffe12255 GET /v1/drugs/e839aa4e-22cc-4f31-8e98-8642ffe12255?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": "INTRAVENOUS",
"source": "ndc",
"strength": "5",
"substance": "MITOMYCIN",
"productndc": "65219-564",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"dea_schedule": null,
"strength_unit": "mg/10mL",
"application_number": "ANDA215687",
"marketing_category": "ANDA"
}See everything about mitomycin.
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.