United States· US:53401-008_4f721786-dab7-3405-e063-6294a90a6bbb

Naltrexone Hydrochloride

A naltrexone product containing naltrexone hydrochloride, registered in United States by Aphena Pharma Solutions - Tennessee, LLC. The same ATC class is registered in 16 of our 19 countries.

ATC N07BB04US label

Checked against FDA National Drug Code directory (United States) on September 27, 2026

Informational only — not a medical device.

Compare price across countriesPer daily dose · free account Ask the assistant about naltrexone hydrochlorideAnswers with sources · free account Check interactionsSeverity free · mechanism on Growth

Where it is registered

Naltrexone is registered in 16 of 19 countries.

Countries holding a registration under ATC N07BB04 (naltrexone), 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

Search naltrexone products by name

Naltrexone · ATC N07BB04

16 / 19 countries

Belgiumprice
Canada
Czechiaprice
Denmark
Finlandprice
Franceprice
Germany
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 naltrexone costs, country by country.

Normalised to the WHO defined daily dose (50 mg), the median price runs from $1.04 in France to $4.34 in Switzerland — a ×4.2 gap.

United States: $1.14 per daily dose (median across products in the class)
Public list prices, converted to USD at the rate date shown
US figures are pharmacy acquisition cost (CMS NADAC), not retail

Open the full comparison — free account Drug prices for market access

Naltrexone · price per daily dose (50 mg)

USD · FX 28 Sept 2026

CH Switzerland$4.34
IT Italy$2.06
US United States$1.14 (acquisition cost)
FR France$1.04

Median listed price per WHO defined daily dose, in each market that publishes a price. US = pharmacy acquisition cost (CMS NADAC), not a retail price. Open the full comparison

The record

At a glance

FDA National Drug Code directory (United States)

Active substance: NALTREXONE HYDROCHLORIDE
Manufacturer: Aphena Pharma Solutions - Tennessee, LLC
Country: United States (US)
ATC code: N07BB04
ATC class: Naltrexone
Defined daily dose: 50 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
53401-008-31
ndc11
5340100831
600 TABLET, FILM COATED in 1 BOTTLE (53401-008-31)

Regulatory notes

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

Interactions

404 interactions on record for naltrexone.

Graded by severity as the source publishes them — 42 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 naltrexone against other medicines How interaction checks work

Naltrexone · interactions on record

404 records

42 severe
324 moderate
38 info

Most severe, free to view

OpiumA07DA02severe
MipomersenC10AX11severe
LomitapideC10AX12severe
BremelanotideG02CX05severe

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

Naltrexone in 15 other countries

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

All naltrexone products

Authorised across Europe · EMA

The same active substance is authorised in 25 EEA countries. Names it is sold under:

Austria · Dependex, Ethylex
Belgium · Naltrexone Accord
Cyprus · Abernil
Czechia · Adepend, Naltrexone Walter Ritter
Germany · Adepend, Naltrexon-Hcl Neuraxpharm
Denmark · Naltrexon "walter Ritter", Naltrexon Accord
Estonia · Naltrexone Accord
Spain · Tranalex
Finland · Naldix, Naltrexon Accord
France · Naltrexone Accord, Naltrexone Viatris
United Kingdom (Northern Ireland) · Adepend, Naltrexone Hydrochloride Accord Healthcare
Croatia · Adepend, Naltreksonklorid Walter Ritter
Hungary · Adepend
Ireland · Ethylex, Naltrexone Hydrochloride Accord Healthcare Ireland
Italy · Antaxone, Nalorex
Lithuania · Naltrexone Accord
Latvia · Naltrexone Accord
Netherlands · Naltrexon Hcl Walter Ritter, Naltrexon Hydrochloride Accord
Norway · Naltrexone Accord, Naltrexone Poa Pharma
Poland · Adepend, Naltex
Portugal · Destoxican, Naltrexona Accord
Romania · Naltrexona Amomed, Naltrexona Walter Ritter
Sweden · Naltrexon Molteni, Naltrexon Vitaflo
Slovenia · Adepend, Naltrekson Walter Ritter
Slovakia · Adepend

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/95ab895b-2c3d-43e7-8f65-573d8b73cf61
GET /v1/drugs/95ab895b-2c3d-43e7-8f65-573d8b73cf61?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": "50",
  "substance": "NALTREXONE HYDROCHLORIDE",
  "productndc": "53401-008",
  "dosage_form": "TABLET, FILM COATED",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA075274",
  "marketing_category": "ANDA"
}

API reference MCP server Plans

See everything about naltrexone.

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.

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