AMIODARONE HYDROCHLORIDE FOR INJECTION, USP 50 MG — DIN 02245248
AMIODARONE HYDROCHLORIDE : 50 MG · FRESENIUS KABI CANADA LTD · SOLUTION · wholesale supply in Canada
Health Canada status: MARKETED
What is AMIODARONE HYDROCHLORIDE FOR INJECTION, USP?
AMIODARONE HYDROCHLORIDE FOR INJECTION, USP 50 MG contains AMIODARONE HYDROCHLORIDE : 50 MG. It is listed in the Health Canada Drug Product Database under DIN 02245248, held by FRESENIUS KABI CANADA LTD, supplied as SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 25-May-2023. 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 HYDROCHLORIDE FOR INJECTION, USP used for?
Initiation of treatment for life-threatening, frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) refractory to other treatment.
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 5 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. Austria publishes a KVP (Kassenverkaufspreis); Czechia publishes a max producer price (ex-factory); Luxembourg publishes a reimbursement. 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 |
|---|---|---|---|---|
| Czechia | max producer price (ex-factory) | 4 | 14 | CZK███.██ |
| South Africa | single exit price | 7 | 7 | ZAR███.██ |
| Austria | KVP (Kassenverkaufspreis) | 2 | 3 | EUR███.██ |
| Luxembourg | reimbursement | 2 | 2 | EUR███.██ |
| United Arab Emirates | public | 1 | 1 | AED███.██ |
27 pack listings across 16 brand entries and 5 price bases, refreshed 05 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 | 50 MG |
|---|---|
| Dosage form | SOLUTION |
| Route | INTRAVENOUS |
| Pack configuration (monograph) | 5 mL Type I amber glass multiuse vials containing 3 mL of solution (50 mg/mL). Available in packages of 25 vials. |
| Storage | Amiodarone Hydrochloride for Injection, USP does not need to be protected from light during administration. (Specific temperature range not provided in text snippet). |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation, because this listing covers more than one of them.
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) | 02245248 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2245248 |
| Brand name | AMIODARONE HYDROCHLORIDE FOR INJECTION, USP |
| Generic / active ingredient | AMIODARONE HYDROCHLORIDE : 50 MG |
| Market authorization holder | FRESENIUS KABI CANADA LTD |
| Health Canada schedule | Prescription |
| ATC code | C01BD01 |
| ATC anatomical main group | C — Cardiovascular system |
| ATC therapeutic subgroup | C01BD |
| Current status | MARKETED |
| Status date | 25-May-2023 |
| Original market date | 2002-04-23 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Must be diluted. First 24h: 150mg rapid loading (10 min), 360mg slow loading (6h), then 540mg maintenance (18h). Maintenance rate 0.5 mg/min. Administer via volumetric pump and in-line filter.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Known hypersensitivity to components; cardiogenic shock; severe sinus-node dysfunction causing bradycardia; second- or third-degree AV block; syncope due to bradycardia (except with pacemaker).
Warnings and precautions
Serious pulmonary toxicity (fatal in 10%); liver injury; proarrhythmia; hypotension. Must be initiated in hospital. Adsorbs to PVC; leaches DEHP. Use central venous catheter for long infusions.
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 | SANIS HEALTH INC | MARKETED | 02364336 |
| AMIODARONE | 200 MG | TABLET | SIVEM PHARMACEUTICALS ULC | MARKETED | 02385465 |
| AMIODARONE HYDROCHLORIDE FOR INJECTION | 50 MG | SOLUTION | SANDOZ CANADA INCORPORATED | MARKETED | 02242325 |
| APO-AMIODARONE TABLETS | 200 MG | TABLET | APOTEX INC | MARKETED | 02246194 |
| JAMP AMIODARONE | 200 MG | TABLET | JAMP PHARMA CORPORATION | MARKETED | 02531844 |
| PMS-AMIODARONE | 200 MG | TABLET | PHARMASCIENCE INC | MARKETED | 02242472 |
| PMS-AMIODARONE | 100 MG | TABLET | PHARMASCIENCE INC | MARKETED | 02292173 |
| 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 HYDROCHLORIDE FOR INJECTION, USP 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 | Czechia |
| RIVODARON | Latin | Czechia |
| Amiodarone IV Activo | Latin | South Africa |
| AMIOKORDIN | Latin | Czechia |
| Amiotach | Latin | South Africa |
| Bio-Amiodarone | Latin | South Africa |
| SEDACORON | Latin | Czechia |
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.
What is Amiodarone called in other languages?
Buyers, prescribers and procurement teams outside Canada often search for the ingredient in their own script. These are phonetic renderings of the ingredient name Amiodarone, published to help those searches reach this page.
| Language | Amiodarone |
|---|---|
| Chinese (Simplified) 简体中文 | 胺碘酮 |
| Russian Русский | Амиодарон |
These are transliterations of the ingredient name, generated automatically and published only where two independent checks agreed. They are not registered local trade names and carry no marketing authorisation in any market. Always confirm a product against its local registration before ordering.
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.
Request a quote for AMIODARONE HYDROCHLORIDE FOR INJECTION, USP
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.