United States· US:27505-111_5bafa407-4ae6-2d85-e063-6394a90aba71

Xadago

A safinamide product containing safinamide mesylate, registered in United States by MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc.. The same ATC class is registered in 17 of our 19 countries.

ATC N04BD03

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

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedXadagoATCN04BD03REGISTER NO.US:27505-111_5bafa407…PACKS LISTED3CHECKEDSeptember 27, 2026

Where it is registered

Safinamide is registered in 17 of 19 countries.

Countries holding a registration under ATC N04BD03 (safinamide), 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

Safinamide · ATC N04BD03

17 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Germany
  • Icelandprice
  • Italyprice
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • Spainprice
  • 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 safinamide costs, country by country.

Normalised to the WHO defined daily dose (75 mg), the median price runs from $2.78 in Spain to $5.29 in Italy — a ×1.9 gap.

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

Safinamide · price per daily dose (75 mg)

USD · FX 28 Sept 2026

  • IT Italy$5.29
  • CH Switzerland$4.79
  • ES Spain$2.78
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
SAFINAMIDE MESYLATE
Manufacturer
MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc.
Country
United States (US)
ATC code
N04BD03
ATC class
Safinamide
Defined daily dose
75 mg, O
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 3

  • ndc11
    27505-111-14
  • ndc11
    27505-111-30
  • ndc11
    27505-111-90

Regulatory notes

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

Interactions

158 interactions on record for safinamide.

Graded by severity as the source publishes them — 18 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

Safinamide · interactions on record

158 records

  • 18 severe
  • 140 moderate

Most severe, free to view

  • FenfluramineA08AA02severe
  • DexfenfluramineA08AA04severe
  • SibutramineA08AA10severe
  • DoxepinD04AX01severe
  • 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

Safinamide in 15 other countries

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

All safinamide products

Authorised across Europe · EMA

The same active substance is authorised in 21 EEA countries. Names it is sold under:

  • Belgium · Safinamide Ab, Safinamide Eg
  • Cyprus · Orvago
  • Germany · Safinamid Al, Safinamid Puren
  • Denmark · Safinamid Vivanta
  • Estonia · Safinamide Teva
  • Spain · Safinamida Aurovitas, Safinamida Cinfa
  • Finland · Safinamide Vivanta
  • United Kingdom (Northern Ireland) · Safinamide Amarox, Safinamide Milpharm
  • Greece · Orvago, Safinamide Win Medica
  • Croatia · Safinamid Msn, Safinamide Msn
  • Iceland · Xadago
  • Italy · Safinamide Aurobindo, Safinamide Doc
  • Liechtenstein · Xadago
  • Lithuania · Safinamide Teva
  • Luxembourg · Safinamide Eg
  • Latvia · Safinamide Teva
  • Malta · Safinamide Nio
  • Netherlands · Safinamide Vivanta
  • Norway · Safinamide Vivanta, Xadago
  • Portugal · Safinamida Aurobindo, Safinamida Generis
  • Sweden · Orvago, Safinamid Doc

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/31b29fd4-803d-4c31-892d-80345926ee1b
GET /v1/drugs/31b29fd4-803d-4c31-892d-80345926ee1b?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": "100",
  "substance": "SAFINAMIDE MESYLATE",
  "productndc": "27505-111",
  "dosage_form": "TABLET, FILM COATED",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "NDA207145",
  "marketing_category": "NDA"
}

See everything about safinamide.

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.