United States· US:16571-821_b75f958e-33bc-434d-a4ae-e5fa9d6f4ab5

TEMOZOLOMIDE

A temozolomide product containing temozolomide, registered in United States by Rising Pharma Holdings, Inc.. The same ATC class is registered in 17 of our 19 countries.

ATC L01AX03US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedTEMOZOLOMIDEATCL01AX03REGISTER NO.US:16571-821_b75f958e…PACKS LISTED4CHECKEDSeptember 27, 2026

Where it is registered

Temozolomide is registered in 17 of 19 countries.

Countries holding a registration under ATC L01AX03 (temozolomide), 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

Temozolomide · ATC L01AX03

17 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Germany
  • Icelandprice
  • Ireland
  • Italyprice
  • Netherlands
  • Norwayprice
  • Polandprice
  • Sweden
  • Switzerlandprice
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

Price per daily dose

What a daily dose of temozolomide costs, country by country.

Normalised to the WHO defined daily dose (65 mg), so markets compare like for like.

  • 2 markets with a comparable price for this class
  • Public list prices, converted to USD at the rate date shown

Temozolomide · price per daily dose (65 mg)

USD · FX 28 Sept 2026

  • IT Italy$43.87
  • CH Switzerland$34.49
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
TEMOZOLOMIDE
Manufacturer
Rising Pharma Holdings, Inc.
Country
United States (US)
ATC code
L01AX03
ATC class
Temozolomide
Defined daily dose
65 mg, O
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 4

  • ndc11
    1657182102
    20 CAPSULE in 1 BOTTLE (16571-821-02)
  • ndc11
    1657182151
    5 CAPSULE in 1 BOTTLE (16571-821-51)
  • ndc11
    16571-821-02
  • ndc11
    16571-821-51

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Interactions

354 interactions on record for temozolomide.

Graded by severity as the source publishes them — 33 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

Temozolomide · interactions on record

354 records

  • 33 severe
  • 103 moderate
  • 16 minor
  • 202 info

Most severe, free to view

  • MipomersenC10AX11severe
  • LomitapideC10AX12severe
  • CladribineL01BB04severe
  • PexidartinibL01EX15severe
  • 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.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Temozolomide in 17 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All temozolomide products

Authorised across Europe · EMA

The same active substance is authorised in 24 EEA countries. Names it is sold under:

  • Cyprus · Advecit, Ridoca
  • Czechia · Temozolomide Glenmark
  • Germany · Temozo-Cell, Temozolomid Cipla
  • Denmark · Temozolomid Fair-Med, Temozolomid Stada
  • Estonia · Blastomat
  • Finland · Temozolomid Ratiopharm
  • France · Kimozo, Temozolomide Viatris
  • United Kingdom (Northern Ireland) · Temozolomide, Temozolomide Crescent Pharma
  • Greece · Ridoca
  • Croatia · Temazol, Temozolomid Pgf Pharma
  • Hungary · Temozolomide Pharmacenter
  • Ireland · Temozolomide Clonmel, Temozolomide Fair-Med
  • Iceland · Temodal, Temomedac
  • Liechtenstein · Temodal, Temomedac
  • Lithuania · Blastomat
  • Latvia · Blastomat
  • Malta · Temozolomide Clonmel 100mg Hard Capsules, Temozolomide Clonmel 140mg Hard Capsules
  • Netherlands · Blastomat, Nogron
  • Norway · Temodal, Temomedac
  • Poland · Temozolomide Fair-Med, Temozolomide Glenmark
  • Portugal · Temozolomida, Temozolomide
  • Romania · Temozolomidă Hf
  • Sweden · Temozolomid Stada, Temozolomide Pgf Pharma
  • Slovakia · Temostad

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/cad8450d-688b-4a5b-90c4-351878686d67
GET /v1/drugs/cad8450d-688b-4a5b-90c4-351878686d67?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",
  "source": "ndc",
  "strength": "250",
  "substance": "TEMOZOLOMIDE",
  "productndc": "16571-821",
  "dosage_form": "CAPSULE",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA206309",
  "marketing_category": "ANDA"
}

See everything about temozolomide.

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.