United States· US:80425-0156_2a99a7c1-c4c2-2b01-e063-6294a90aa3b8

Baclofen

A baclofen product containing baclofen, registered in United States by Advanced Rx Pharmacy of Tennessee, LLC. The same ATC class is registered in 18 of our 19 countries.

ATC M03BX01US 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…normalisedBaclofenATCM03BX01REGISTER NO.US:80425-0156_2a99a7c…PACKS LISTED8CHECKEDSeptember 27, 2026

Where it is registered

Baclofen is registered in 18 of 19 countries.

Countries holding a registration under ATC M03BX01 (baclofen), 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

Baclofen · ATC M03BX01

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.

Price per daily dose

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

Normalised to the WHO defined daily dose (50 mg), the median price runs from $0.41 in Italy to $1.72 in Switzerland — a ×4.1 gap.

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

Baclofen · price per daily dose (50 mg)

USD · FX 28 Sept 2026

  • CH Switzerland$1.72
  • FR France$0.66
  • IT Italy$0.41
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
BACLOFEN
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Country
United States (US)
ATC code
M03BX01
ATC class
Baclofen
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 · 8

  • ndc11
    8042501561
    30 TABLET in 1 BOTTLE (80425-0156-1)
  • ndc11
    8042501562
    60 TABLET in 1 BOTTLE (80425-0156-2)
  • ndc11
    8042501563
    90 TABLET in 1 BOTTLE (80425-0156-3)
  • ndc11
    8042501564
    120 TABLET in 1 BOTTLE (80425-0156-4)
  • ndc11
    80425-0156-1
  • ndc11
    80425-0156-2
  • ndc11
    80425-0156-3
  • ndc11
    80425-0156-4

Regulatory notes

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

Interactions

163 interactions on record for baclofen.

Graded by severity as the source publishes them — 4 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

Baclofen · interactions on record

163 records

  • 4 severe
  • 62 moderate
  • 1 minor
  • 95 info

Most severe, free to view

  • MorphineN02AA01severe
  • MorphinN07BC09severe
  • HydrocodoneR05DA03severe
  • CodeineR05DA04severe

1 more interaction with mechanism and management, from a commercially licensed source.

Sign in to check
  • 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

Baclofen in 16 other countries

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

All baclofen products

Authorised across Europe · EMA

The same active substance is authorised in 30 EEA countries. Names it is sold under:

  • Austria · Baclofen Intrathekal Sintetica, Lioresal
  • Belgium · Baclofen Esspharm, Baclofen Intrathecal Aguettant
  • Bulgaria · Баклофен Фармадвайс
  • Cyprus · Colmifen
  • Czechia · Baclofen Polpharma, Baclofen Sintetica
  • Germany · Baclaxiro, Baclofen Al
  • Denmark · Baclofen Accord, Baclofen Medical Valley
  • Estonia · Baclofen Sintetica
  • Spain · Baclofen, Baclofeno Combix
  • Finland · Baclofen Afortas, Baclofen Sintetica
  • France · Baclocur, Baclofen Aguettant
  • United Kingdom (Northern Ireland) · Baclofen, Baclofen Accord
  • Greece · Baclofen Sintetica, Miorel
  • Croatia · Baklofen Intratekalni Sintetica, Fezea
  • Hungary · Baclofen Pol, Baclofen Sintetica
  • Ireland · Baclofen Syri Pharma, Baclopar
  • Iceland · Baclofen Í Mænuvökva Sintetica, Baklofen Viatris
  • Italy · Baclofene Bioindustria L.I.M., Baclofene Doc
  • Lithuania · Baclosal
  • Luxembourg · Lioresal, Lioresal Intrathecal
  • Latvia · Baclofen Sintetica, Baclosal
  • Malta · Baclofen Thame, Baclofene Bioindustria L.I.M.
  • Netherlands · Baclofen Aurobindo, Baclofen Intrathecaal Sintetica
  • Norway · Baclofen Accord, Baclofen Afortas
  • Poland · Baclofen Polpharma, Baclofen Sintetica
  • Portugal · Baclofeno Generis, Lioresal
  • Romania · Lioresal
  • Sweden · Baclofen Accord, Baclofen Afortas
  • Slovenia · Baklofen Sintetica, Fezea
  • Slovakia · Baclofen Polpharma, Baclofen Sintetica

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/b1317825-0a6d-4fae-817f-c555a19bf76c
GET /v1/drugs/b1317825-0a6d-4fae-817f-c555a19bf76c?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": "10",
  "substance": "BACLOFEN",
  "productndc": "80425-0156",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA212378",
  "marketing_category": "ANDA"
}

See everything about baclofen.

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.