United States· US:71610-660_70e07130-7d44-48d3-9ad3-f9ea3477ba2e

Baclofen

A baclofen product containing baclofen, registered in United States by Aphena Pharma Solutions - 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:71610-660_70e07130…PACKS LISTED6CHECKEDSeptember 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
Aphena Pharma Solutions - 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 · 6

  • ndc11
    7161066060
    90 TABLET in 1 BOTTLE (71610-660-60)
  • ndc11
    7161066080
    180 TABLET in 1 BOTTLE (71610-660-80)
  • ndc11
    7161066092
    270 TABLET in 1 BOTTLE (71610-660-92)
  • ndc11
    71610-660-60
  • ndc11
    71610-660-80
  • ndc11
    71610-660-92

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/d384dcad-3b1e-4117-97ce-0aa22062beb6
GET /v1/drugs/d384dcad-3b1e-4117-97ce-0aa22062beb6?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": "71610-660",
  "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.