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United States· US:70709-005_9e29c768-8b6d-40c0-a8ee-72dfcf4dbe92

NITYR

A nitisinone product containing nitisinone, registered in United States by Cycle Pharmaceuticals Ltd.. The same ATC class is registered in 18 of our 19 countries.

ATC A16AX04US 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…normalisedNITYRATCA16AX04REGISTER NO.US:70709-005_9e29c768…PACKS LISTED2CHECKEDSeptember 27, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about nitisinoneAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Nitisinone is registered in 18 of 19 countries.

Countries holding a registration under ATC A16AX04 (nitisinone), 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
Search nitisinone products by name

Nitisinone · ATC A16AX04

18 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Germany
  • Icelandprice
  • Ireland
  • Italyprice
  • Japan
  • 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.

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
NITISINONE
Manufacturer
Cycle Pharmaceuticals Ltd.
Country
United States (US)
ATC code
A16AX04
ATC class
Nitisinone
Defined daily dose
20 mg, O
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 2

  • ndc11
    7070900560
    1 BOTTLE, PLASTIC in 1 CARTON (70709-005-60) / 60 TABLET in 1 BOTTLE, PLASTIC
  • ndc11
    70709-005-60

Regulatory notes

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

Interactions

235 interactions on record for nitisinone.

Graded by severity as the source publishes them — 2 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
Check nitisinone against other medicinesHow interaction checks work

Nitisinone · interactions on record

235 records

  • 2 severe
  • 231 moderate
  • 2 minor

Most severe, free to view

  • ClotrimazoleA01AB18moderate
  • CimetidineA02BA01moderate
  • DronabinolA04AD10moderate
  • AprepitantA04AD12moderate
  • 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

Nitisinone in 16 other countries

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

All nitisinone products

Authorised across Europe · EMA

The same active substance is authorised in 18 EEA countries. Names it is sold under:

  • Austria · Nitisinon Dipharma
  • Belgium · Nitisinone Dipharma
  • Bulgaria · Тисинон
  • Germany · Nitisinone Dipharma
  • Denmark · Nitisinone Dipharma
  • Spain · Nitisinona Dipharma
  • Finland · Nitisinone Dipharma
  • France · Nitisinone Dipharma
  • United Kingdom (Northern Ireland) · Nitisinone Logixx Pharma
  • Ireland · Nitisinone Dipharma
  • Iceland · Orfadin
  • Italy · Nitisinone Dipharma
  • Liechtenstein · Orfadin
  • Netherlands · Nitisinone Dipharma
  • Norway · Nitisinone Dipharma, Orfadin
  • Portugal · Nitisinona Dipharma
  • Sweden · Nitisinone Dipharma
  • Slovakia · Nitisinone Dipharma

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/fc15a54e-6a9e-42f8-84b7-16ed6bc9a8ab
GET /v1/drugs/fc15a54e-6a9e-42f8-84b7-16ed6bc9a8ab?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": "5",
  "substance": "NITISINONE",
  "productndc": "70709-005",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "NDA209449",
  "marketing_category": "NDA"
}
API referenceMCP serverPlans

See everything about nitisinone.

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.

Try it freeOpen in the console