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United States· US:65841-631_aabb5533-5d41-49a3-b8b6-14627af57311

Amiodarone hydrochloride

A amiodarone product containing amiodarone hydrochloride, registered in United States by Zydus Lifesciences Limited. The same ATC class is registered in 19 of our 19 countries.

ATC C01BD01US 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…normalisedAmiodarone hydrochlorideATCC01BD01REGISTER NO.US:65841-631_aabb5533…PACKS LISTED10CHECKEDSeptember 27, 2026

Where it is registered

Amiodarone is registered in 19 of 19 countries.

Countries holding a registration under ATC C01BD01 (amiodarone), 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

Amiodarone · ATC C01BD01

19 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Germany
  • Icelandprice
  • Ireland
  • 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 amiodarone costs, country by country.

Normalised to the WHO defined daily dose (0.2 g), the median price runs from $0.13 in Spain to $0.98 in Switzerland — a ×7.5 gap.

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

Amiodarone · price per daily dose (0.2 g)

USD · FX 28 Sept 2026

  • CH Switzerland$0.98
  • FR France$0.27
  • IT Italy$0.26
  • ES Spain$0.13
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
AMIODARONE HYDROCHLORIDE
Manufacturer
Zydus Lifesciences Limited
Country
United States (US)
ATC code
C01BD01
ATC class
Amiodarone
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 · 10

  • ndc11
    6584163105
    500 TABLET in 1 BOTTLE (65841-631-05)
  • ndc11
    6584163106
    30 TABLET in 1 BOTTLE (65841-631-06)
  • ndc11
    6584163110
    1000 TABLET in 1 BOTTLE (65841-631-10)
  • ndc11
    6584163114
    60 TABLET in 1 BOTTLE (65841-631-14)
  • ndc11
    6584163177
    10 BLISTER PACK in 1 CARTON (65841-631-77) / 10 TABLET in 1 BLISTER PACK
  • ndc11
    65841-631-05
  • ndc11
    65841-631-06
  • ndc11
    65841-631-10
  • ndc11
    65841-631-14
  • ndc11
    65841-631-77

Regulatory notes

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

Interactions

552 interactions on record for amiodarone.

Graded by severity as the source publishes them — 166 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

Amiodarone · interactions on record

552 records

  • 166 severe
  • 219 moderate
  • 8 minor
  • 75 info

Most severe, free to view

  • ClotrimazoleA01AB18severe
  • PapaverineA03AD01severe
  • CisaprideA03FA02severe
  • OndansetronA04AA01severe

84 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

Amiodarone in 18 other countries

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

All amiodarone products

Authorised across Europe · EMA

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

  • Austria · Amiodaron Hameln, Amiodaron Hcl Hikma
  • Belgium · Amiodarone Ab, Amiodarone Eg
  • Bulgaria · Амиодарон Xамелн, Амиодарон Софарма
  • Cyprus · Amiodarone Aurobindo, Amiodarone Medochemie
  • Czechia · Amiodaron Hameln, Amiokordin
  • Germany · Amiodaron, Amiodaron 1 A Pharma
  • Denmark · Amiodaron Hameln, Cordan
  • Estonia · Amiokordin
  • Spain · Amiodarona Aurovitas, Trangorex
  • Finland · Amiodaron Hameln, Cordarone
  • France · Amiodarone Almus, Amiodarone Arrow Lab
  • United Kingdom (Northern Ireland) · Amiodarone, Amiodarone 100 Mg
  • Greece · Angoron
  • Croatia · Amiodaron Hameln, Amiodaronklorid Belupo
  • Hungary · Amiodaron Hameln, Cordarone
  • Ireland · Cordarone X, Cordarone X Intravenous
  • Iceland · Cordarone
  • Italy · Amiodar, Amiodarone Aurobindo
  • Lithuania · Amiokordin, Cordarone
  • Luxembourg · Amiodarone Eg, Cordarone
  • Latvia · Amiokordin
  • Malta · Amiodarone Accord Healthcare, Amiodarone Ibigen
  • Netherlands · Amiodaron Hameln, Amiodaron Hcl Aurobindo
  • Norway · Amiodaron Hameln, Cordarone
  • Poland · Amiodaron Hameln, Amiokordin
  • Portugal · Amiodarona Aurovitas, Amiodarona Bluepharma
  • Romania · Amiodaron Hameln, Amiodarona Arena
  • Sweden · Amiodaron Evolan, Amiodaron Hameln
  • Slovenia · Amiokordin, Amjodaron Hameln
  • Slovakia · Amiodaron Hameln, Amiokordin

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/fae32e72-146e-43db-beb6-522304cdca9f
GET /v1/drugs/fae32e72-146e-43db-beb6-522304cdca9f?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": "200",
  "substance": "AMIODARONE HYDROCHLORIDE",
  "productndc": "65841-631",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA079029",
  "marketing_category": "ANDA"
}

See everything about amiodarone.

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.