AMIODARONE 200 MG — DIN 02364336
AMIODARONE HYDROCHLORIDE : 200 MG · SANIS HEALTH INC · TABLET · wholesale supply in Canada
Health Canada status: MARKETED
What is AMIODARONE?
AMIODARONE 200 MG contains AMIODARONE HYDROCHLORIDE : 200 MG. It is listed in the Health Canada Drug Product Database under DIN 02364336, held by SANIS HEALTH INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 26-May-2026. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is AMIODARONE used for?
Treatment of documented life-threatening, recurrent ventricular arrhythmias (unstable VT, recurrent VF) unresponsive to other available antiarrhythmics or when others are not tolerated.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Amiodarone cost around the world?
Amiodarone is listed on 8 of the national price registers Nexara ingests. Each country publishes on a different basis, so those figures are not comparable with one another — or with a Canadian wholesale price.
What a market publishes matters more than the number it publishes. Australia publishes a ex-manufacturer; Greece publishes a producer price (ex-factory); Italy publishes a ex-factory (classe H). Comparing an ex-factory ceiling against a pharmacy public price tells you nothing about either, and comparing either against a Canadian landed cost tells you less.
| Market | Price basis published there | Brands | Packs listed | Range |
|---|---|---|---|---|
| United States | acquisition | 4 | 28 | USD███.██ |
| Italy | prezzo al pubblico (classe A) | 3 | 8 | EUR███.██ |
| South Africa | single exit price | 6 | 7 | ZAR███.██ |
| Australia | ex-manufacturer | 6 | 6 | AUD███.██ |
| United Kingdom | hospital | 5 | 5 | GBP███.██ |
| Saudi Arabia | public | 5 | 5 | SAR███.██ |
| Italy | ex-factory (classe H) | 4 | 4 | EUR███.██ |
| Greece | producer price (ex-factory) | 2 | 2 | EUR███.██ |
| Morocco | PPV (public price) | 1 | 2 | MAD███.██ |
67 pack listings across 36 brand entries and 9 price bases, refreshed 08 Sep 2026. Ranges span every Amiodarone pack in that market, so a high figure is usually a larger pack rather than the same product.
Canada publishes no comparable public list price. For a delivered Canadian price on a licensed account, verify your licence — it takes about a minute.
Is there a generic Amiodarone in Canada, and who makes it?
Every market authorization holder with a Canadian DIN for this molecule, and how many of their listings Health Canada currently shows as marketed.
22 holders have a Canadian DIN containing Amiodarone, across 35 DINs, of which 12 are currently marketed. Marketed count is the number that matters: an approval that is not marketed cannot be bought.
| Market authorization holder | DINs | Marketed | Brand names | Position |
|---|---|---|---|---|
| SANDOZ CANADA INCORPORATED | 3 | 2 | AMIODARONE HYDROCHLORIDE FOR INJECTION, AMIODARONE SYRINGE, SANDOZ AMIODARONE | Sourceable in Canada |
| PHARMASCIENCE INC | 2 | 2 | PMS-AMIODARONE | Sourceable in Canada |
| TEVA CANADA LIMITED | 3 | 1 | AMIODARONE FOR INJECTION 50MG/ML, NTP-AMIODARONE, TEVA-AMIODARONE | Sourceable in Canada |
| JAMP PHARMA CORPORATION | 2 | 1 | AMIODARONE HYDROCHLORIDE FOR INJECTION, JAMP AMIODARONE | Sourceable in Canada |
| LABORATOIRE RIVA INC. | 2 | 1 | RIVA-AMIODARONE | Sourceable in Canada |
| APOTEX INC | 1 | 1 | APO-AMIODARONE TABLETS | Sourceable in Canada |
| FRESENIUS KABI CANADA LTD | 1 | 1 | AMIODARONE HYDROCHLORIDE FOR INJECTION, USP | Sourceable in Canada |
| PRO DOC LIMITEE | 1 | 1 | PRO-AMIODARONE - 200 | Sourceable in Canada |
| SANIS HEALTH INC | 1 | 1 | AMIODARONE | Sourceable in Canada |
| SIVEM PHARMACEUTICALS ULC | 1 | 1 | AMIODARONE | Sourceable in Canada |
| MYLAN PHARMACEUTICALS ULC | 3 | 0 | AMIODARONE HYDROCHLORIDE INJECTION, MYLAN-AMIODARONE | No marketed DIN |
| PFIZER CANADA ULC | 2 | 0 | AMIODARONE HYDROCHLORIDE FOR INJECTION, CORDARONE | No marketed DIN |
Health Canada’s Drug Product Database does not flag which listing is the originator and which are subsequent-entry products, so Nexara does not label them here. Interchangeability is determined provincially, not federally — confirm for your province before a formulary switch. Nexara can confirm which of these is actually obtainable, and on what lead time, per order.
How is it supplied and stored?
Pack configuration, storage class and the handling constraints that drive cold-chain planning. One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced.
| Strength on the label | 200 MG |
|---|---|
| Dosage form | TABLET |
| Route | ORAL |
| Pack configuration (monograph) | Not explicitly detailed in provided text (Summary section mentions 200 mg tablets). |
| Storage | Not specified in the provided text (refer to page 34 of full monograph). |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Amiodarone |
|---|---|
| ATC code | C01BD01 |
| AHFS class | 24:04.04.20 |
| Biosimilar biologic | No |
Health Canada record and identifiers
The regulatory facts straight from the Drug Product Database, plus every identifier form Nexara accepts on a purchase order. A DIN written without its leading zeros is the commonest reason an order line fails to match.
| DIN (8-digit, as used in ordering) | 02364336 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2364336 |
| Brand name | AMIODARONE |
| Generic / active ingredient | AMIODARONE HYDROCHLORIDE : 200 MG |
| Market authorization holder | SANIS HEALTH INC |
| Health Canada schedule | Prescription |
| ATC code | C01BD01 |
| ATC anatomical main group | C — Cardiovascular system |
| ATC therapeutic subgroup | C01BD |
| Current status | MARKETED |
| Status date | 26-May-2026 |
| Original market date | 2011-06-10 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Initiate in hospital. Loading doses are higher and may cause nausea/tremor. Maintenance dose selection is difficult due to variable absorption/elimination; dose reduction often required.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to amiodarone or iodine; cardiogenic shock; severe sinus-node dysfunction; 2nd/3rd degree AV block; syncope from bradycardia (without pacemaker); hepatitis; thyroid dysfunction.
Warnings and precautions
Fatal toxicities: pulmonary toxicity, liver injury, and proarrhythmia. Requires hospitalization for loading. Long half-life complicates management. Risk of thyrotoxicosis.
Is Amiodarone in shortage in Canada?
A Canadian shortage report is on file for a product containing this molecule: Resolved — reported by JAMP PHARMA CORPORATION, last seen 20 Mar 2026. A shortage on one presentation does not always affect every DIN of the molecule — the alternatives below list what else is marketed in Canada. Nexara can confirm current availability and identify substitutions or import options where permitted.
What can be used instead?
Alternatives on every axis a buyer actually considers — the same molecule in another presentation, the same class, an adjacent class, or a fixed-dose combination. Every row is led by the marketed DIN count, because that is what can be bought this week.
1 · Same molecule, other Canadian presentations
12 of 35 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| AMIODARONE | 200 MG | TABLET | SIVEM PHARMACEUTICALS ULC | MARKETED | 02385465 |
| AMIODARONE HYDROCHLORIDE FOR INJECTION | 50 MG | SOLUTION | SANDOZ CANADA INCORPORATED | MARKETED | 02242325 |
| AMIODARONE HYDROCHLORIDE FOR INJECTION, USP | 50 MG | SOLUTION | FRESENIUS KABI CANADA LTD | MARKETED | 02245248 |
| APO-AMIODARONE TABLETS | 200 MG | TABLET | APOTEX INC | MARKETED | 02246194 |
| JAMP AMIODARONE | 200 MG | TABLET | JAMP PHARMA CORPORATION | MARKETED | 02531844 |
| PMS-AMIODARONE | 100 MG | TABLET | PHARMASCIENCE INC | MARKETED | 02292173 |
| PMS-AMIODARONE | 200 MG | TABLET | PHARMASCIENCE INC | MARKETED | 02242472 |
| PRO-AMIODARONE - 200 | 200 MG | TABLET | PRO DOC LIMITEE | MARKETED | 02309661 |
| RIVA-AMIODARONE | 200 MG | TABLET | LABORATOIRE RIVA INC. | MARKETED | 02247217 |
| SANDOZ AMIODARONE | 200 MG | TABLET | SANDOZ CANADA INCORPORATED | MARKETED | 02243836 |
2 · Same class — other molecules in ATC C01BD
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Amiodarone | AMIODARONE · AMIODARONE FOR INJECTION 50MG/ML · AMIODARONE HYDROCHLORIDE FOR INJECTION · AMIODARONE HYDROCHLORIDE FOR INJECTION, USP · +22 more | 35 | 12 | Yes |
| Dronedarone | ASN-DRONEDARONE · MULTAQ | 2 | 1 | Yes |
| Ibutilide | CORVERT | 1 | 1 | Yes |
| Bretylium Tosilate | BRETYLATE INJ 50MG/ML · BRETYLIUM TOSYLATE 0.2% AND DEXTROSE 5% INJ · BRETYLIUM TOSYLATE 0.4% AND DEXTROSE 5% INJ · BRETYLIUM TOSYLATE INJ 50MG/ML · +1 more | 5 | 0 | Not in Canada |
A molecule with zero marketed DINs cannot be sourced domestically, however many approvals it holds — if one of these sits on a formulary or in an older protocol, that is the line to check.
3 · Adjacent classes in ATC C01B
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| C01BC | Flecainide · Propafenone | 35 | 16 |
| C01BB | Lidocaine · Mexiletine · Tocainide | 22 | 8 |
| C01BA | Disopyramide · Procainamide · Quinidine | 44 | 1 |
| C01BG | Vernakalant | 1 | 1 |
Not clinical advice. These tables describe what can be supplied in Canada, not what should be prescribed. Substitution within or across classes is a prescriber and pharmacist decision, and interchangeability is determined provincially.
What else is AMIODARONE called?
The same molecule, Amiodarone, is registered under other names elsewhere. Buyers and prescribers searching from outside Canada — or working from a foreign prescription or tender document — often know it by one of these:
| Name | Script | Registered in |
|---|---|---|
| CORDARONE | Latin | Morocco |
| Cordarone X Intravenous | Latin | South Africa |
| Amdarone | Latin | Australia |
| Amiodarone Sandoz | Latin | Australia |
| SEDACORON solution for injection | Latin | Saudi Arabia |
Names are taken from national medicine registers and published price lists. A product registered abroad is not authorized for sale in Canada unless it holds its own DIN; import is possible only through the routes Health Canada permits.
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address. Patients and unlicensed buyers are routed to a partner pharmacy.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Why is there no price on this page?
Nexara quotes a delivered Canadian price per order, against a verified licence. Foreign list prices are published on incompatible bases and are not a guide to what any buyer can obtain here, so this page shows which markets list the molecule and on what basis, and nothing more.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.