United States· US:0143-9565_74c9ff27-7c88-4dff-831d-eab4b8d9f1d7
Thiotepa
A thiotepa product containing thiotepa, registered in United States by Hikma Pharmaceuticals USA Inc.. The same ATC class is registered in 16 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Thiotepa is registered in 16 of 19 countries.
Countries holding a registration under ATC L01AC01 (thiotepa), 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
Thiotepa · ATC L01AC01
16 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Germany
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Sweden
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- THIOTEPA
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Country
- United States (US)
- ATC code
- L01AC01
- ATC class
- Thiotepa
- Defined daily dose
- 1.62 g, P
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc1101439565011 VIAL in 1 BOX, UNIT-DOSE (0143-9565-01) / 1.5 mL in 1 VIAL
- ndc110143-9565-01
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
202 interactions on record for thiotepa.
Graded by severity as the source publishes them — 43 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
Thiotepa · interactions on record
202 records
- 43 severe
- 105 moderate
- 14 minor
- 40 info
Most severe, free to view
- Nalidixic acidJ01MB02severe
- CyclophosphamideL01AA01severe
- ChlorambucilL01AA02severe
- MelphalanL01AA03severe
- 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
Thiotepa in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FinlandTEPADINAOrifarm Oy
- SwedenTEPADINA 100 mg Pulver till koncentrat till infusionsvätska, lösningADIENNE S.r.l.
- SpainTEPADINA 100 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSIONAdienne S.R.L.
- United KingdomTepadina 100mg powder for concentrate for solution for infusion vialsAdienne Pharma & Biotech
- CzechiaTEPADINAADIENNE S.r.l., Caponago
- FranceTEPADINA 100 mg, poudre pour concentré pour solution pour perfusionADIENNE (ITALIE)
- PolandTepadinaADIENNE S.r.l. S.U.
- NetherlandsTepadina 100 mg, poeder voor oplossing voor infusieAdienne S.r.l.
Authorised across Europe · EMA
The same active substance is authorised in 27 EEA countries. Names it is sold under:
- Austria · Thiotepa Fresenius Kabi
- Belgium · Thiotepa Fresenius Kabi
- Bulgaria · Тиотепа Msn
- Czechia · Thiotepa Fresenius Kabi, Thiotepa Msn
- Germany · Thionovia, Thiotepa Fresenius Kabi
- Denmark · Thiotepa Abcur, Thiotepa Fresenius Kabi
- Estonia · Thiotepa Fresenius Kabi, Thiotepa Msn
- Spain · Thionovia, Thiotepa Vivanta
- Finland · Thiotepa Abcur, Thiotepa Fresenius Kabi
- France · Thionovia, Thiotepa Fresenius Kabi
- United Kingdom (Northern Ireland) · Thiotepa, Thiotepa Hikma Farmacêutica (Portugal)
- Croatia · Tiotepa Fresenius Kabi, Tiotepa Msn
- Hungary · Thiotepa, Thiotepa Medac
- Ireland · Thiotepa Fresenius Kabi
- Iceland · Tepadina, Thiotepa Abcur
- Italy · Thionovia, Thiotepa Medac
- Liechtenstein · Tepadina, Thiotepa Riemser
- Lithuania · Thiotepa Fresenius Kabi, Thiotepa Msn
- Latvia · Thiotepa Fresenius Kabi, Thiotepa Msn
- Netherlands · Thiotepa Fresenius Kabi, Thiotepa Medac
- Norway · Tepadina, Thiotepa Abcur
- Poland · Thiotepa Fresenius Kabi, Thiotepa Msn
- Portugal · Tiotepa Fresenius Kabi, Tiotepa Hikma
- Romania · Thiotepa Fresenius Kabi, Thiotepa Msn
- Sweden · Thionovia, Thiotepa Abcur
- Slovenia · Thiotepa Msn
- Slovakia · Thiotepa Fresenius Kabi, Thiotepa Msn
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/cae30538-e741-4af6-bdc8-d29a99efd843 GET /v1/drugs/cae30538-e741-4af6-bdc8-d29a99efd843?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": "INTRACAVITARY; INTRAVENOUS; INTRAVESICAL",
"source": "ndc",
"strength": "15",
"substance": "THIOTEPA",
"productndc": "0143-9565",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"dea_schedule": null,
"strength_unit": "mg/1.5mL",
"application_number": "ANDA075547",
"marketing_category": "ANDA"
}See everything about thiotepa.
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.