Back to search

United States· US:50268-321_48253893-9512-565b-e063-6294a90a8ad8

Flecainide Acetate

A flecainide product containing flecainide acetate, registered in United States by AvPAK. The same ATC class is registered in 18 of our 19 countries.

ATC C01BC04US 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…normalisedFlecainide AcetateATCC01BC04REGISTER NO.US:50268-321_48253893…PACKS LISTED2CHECKEDSeptember 27, 2026

Where it is registered

Flecainide is registered in 18 of 19 countries.

Countries holding a registration under ATC C01BC04 (flecainide), each read from that country’s own register.

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

Flecainide · ATC C01BC04

18 / 19 countries

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

Normalised to the WHO defined daily dose (0.2 g), the median price runs from $0.49 in France to $2.20 in Switzerland — a ×4.5 gap.

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

Flecainide · price per daily dose (0.2 g)

USD · FX 28 Sept 2026

  • CH Switzerland$2.20
  • IT Italy$0.70
  • ES Spain$0.61
  • FR France$0.49
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
FLECAINIDE ACETATE
Manufacturer
AvPAK
Country
United States (US)
ATC code
C01BC04
ATC class
Flecainide
Defined daily dose
0.2 g, 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
    50268-321-15
  • ndc11
    5026832115
    50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-321-15) / 1 TABLET in 1 BLISTER PACK (50268-321-11)

Regulatory notes

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

Interactions

342 interactions on record for flecainide.

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

Flecainide · interactions on record

342 records

  • 42 severe
  • 164 moderate
  • 15 minor
  • 75 info

Most severe, free to view

  • PapaverineA03AD01severe
  • CisaprideA03FA02severe
  • DolasetronA04AA04severe
  • EliglustatA16AX10severe

46 more interactions 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

Flecainide in 16 other countries

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

All flecainide products

Authorised across Europe · EMA

The same active substance is authorised in 26 EEA countries. Names it is sold under:

  • Austria · Aristocor
  • Belgium · Apocard Retard, Flecainide Retard Eg
  • Bulgaria · Амаритон, Фелкарид
  • Cyprus · Flecardia
  • Czechia · Amarhyton, Amarhyton 100 Mg
  • Germany · Flecadura, Flecainid
  • Denmark · Flecainid Sandoz, Flecainid Stada
  • Spain · Apocard, Flecainida Aurovitas
  • Finland · Flecainide Orion, Tambocor
  • France · Flecaine, Flecaine L.P.
  • United Kingdom (Northern Ireland) · Flecainide Acetate Accord-Uk, Flecainide Acetate Brown & Burk Uk
  • Greece · Amarhyton, Flecainide/Flexmed
  • Croatia · Felkarid
  • Ireland · Flecainide Teva, Tambocor
  • Iceland · Flecainid Stada, Tambocor
  • Italy · Almarytm, Flecainide Aurobindo
  • Luxembourg · Apocard Retard, Flecainide Retard Eg
  • Malta · Flecainide Acetate Aurobindo Pharma (Malta), Tambocor
  • Netherlands · Flecainide Acetate Aurobindo, Flecainide Acetate Ratiopharm
  • Norway · Flecainid Sandoz, Tambocor
  • Poland · Flecainide Acetate Holsten
  • Portugal · Amarhyton, Apocard
  • Romania · Amarhyton, Tambocor
  • Sweden · Tambocor, Tambocor Retard
  • Slovenia · Felkarid
  • Slovakia · Amarhyton 100 Mg, Amarhyton 50 Mg

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/cac4540c-1bee-4bf2-afff-73016dce2431
GET /v1/drugs/cac4540c-1bee-4bf2-afff-73016dce2431?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": "FLECAINIDE ACETATE",
  "productndc": "50268-321",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA075442",
  "marketing_category": "ANDA"
}

See everything about flecainide.

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.