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United States· US:42358-295_cb790c3a-2ee7-4712-8e98-dc3748aad320

Nulibry

A fosdenopterin product containing fosdenopterin hydrobromide, registered in United States by Sentynl Therapeutics, Inc.. The same ATC class is registered in 11 of our 19 countries.

ATC A16AX19

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

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedNulibryATCA16AX19REGISTER NO.US:42358-295_cb790c3a…PACKS LISTED1CHECKEDSeptember 27, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about fosdenopterin hydrobromideAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Fosdenopterin is registered in 11 of 19 countries.

Countries holding a registration under ATC A16AX19 (fosdenopterin), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 7 of them publish a price we can compare per daily dose
Search fosdenopterin products by name

Fosdenopterin · ATC A16AX19

11 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • 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
FOSDENOPTERIN HYDROBROMIDE
Manufacturer
Sentynl Therapeutics, Inc.
Country
United States (US)
ATC code
A16AX19
ATC class
Fosdenopterin
Defined daily dose
63 mg, P
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 1

  • ndc11
    42358-295-01

Regulatory notes

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

Same medicine, other countries

Fosdenopterin in 10 other countries

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

All fosdenopterin products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Iceland · Nulibry
  • Liechtenstein · Nulibry
  • Norway · Nulibry

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/56dca853-2222-43d4-a986-9f9da0310503
GET /v1/drugs/56dca853-2222-43d4-a986-9f9da0310503?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": "9.5",
  "substance": "FOSDENOPTERIN HYDROBROMIDE",
  "productndc": "42358-295",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "NDA214018",
  "marketing_category": "NDA"
}
API referenceMCP serverPlans

See everything about fosdenopterin.

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