United States· US:70437-240_44eb88a3-0ac0-2880-e063-6394a90af02f

Nerlynx

A neratinib product containing neratinib maleate anhydrous, registered in United States by Puma Biotechnology, Inc.. The same ATC class is registered in 13 of our 19 countries.

ATC L01EH02US 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…normalisedNerlynxATCL01EH02REGISTER NO.US:70437-240_44eb88a3…PACKS LISTED6CHECKEDJune 26, 2026

Where it is registered

Neratinib is registered in 13 of 19 countries.

Countries holding a registration under ATC L01EH02 (neratinib), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 8 of them publish a price we can compare per daily dose

Neratinib · ATC L01EH02

13 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • 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
NERATINIB MALEATE ANHYDROUS
Manufacturer
Puma Biotechnology, Inc.
Country
United States (US)
ATC code
L01EH02
ATC class
Neratinib
Defined daily dose
0.24 g, O
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
June 26, 2026

Packs & prices · 6

  • ndc11
    7043724018
    1 BOTTLE in 1 BOX (70437-240-18) / 180 TABLET in 1 BOTTLE
  • ndc11
    7043724026
    1 BOTTLE in 1 BOX (70437-240-26) / 126 TABLET in 1 BOTTLE
  • ndc11
    7043724033
    1 BOTTLE in 1 BOX (70437-240-33) / 133 TABLET in 1 BOTTLE
  • ndc11
    70437-240-18
  • ndc11
    70437-240-26
  • ndc11
    70437-240-33

Regulatory notes

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

Interactions

226 interactions on record for neratinib.

Graded by severity as the source publishes them — 97 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

Neratinib · interactions on record

226 records

  • 97 severe
  • 123 moderate
  • 6 minor

Most severe, free to view

  • ClotrimazoleA01AB18severe
  • CimetidineA02BA01severe
  • RanitidineA02BA02severe
  • FamotidineA02BA03severe
  • 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

Neratinib in 13 other countries

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

All neratinib products

Authorised across Europe · EMA

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

  • Iceland · Nerlynx
  • Liechtenstein · Nerlynx
  • Norway · Nerlynx

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/a976f8c9-e74d-4684-8226-0352604d9acd
GET /v1/drugs/a976f8c9-e74d-4684-8226-0352604d9acd?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": "40",
  "substance": "NERATINIB MALEATE ANHYDROUS",
  "productndc": "70437-240",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "NDA208051",
  "marketing_category": "NDA"
}

See everything about neratinib.

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.