ASN-DRONEDARONE 400 MG — DIN 02514397
DRONEDARONE (DRONEDARONE HYDROCHLORIDE) : 400 MG · ASCEND LABORATORIES LTD · TABLET · wholesale supply in Canada
Health Canada status: APPROVED
What is ASN-DRONEDARONE?
ASN-DRONEDARONE 400 MG contains DRONEDARONE (DRONEDARONE HYDROCHLORIDE) : 400 MG. It is listed in the Health Canada Drug Product Database under DIN 02514397, held by ASCEND LABORATORIES LTD, supplied as TABLET for ORAL administration. Health Canada currently lists it as approved, status dated 29-Mar-2021. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A). This DIN is not currently being marketed in Canada, so it is sourced to order where a compliant route exists rather than held in stock.
How much does Dronedarone cost around the world?
Dronedarone is listed on 2 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. Italy publishes a prezzo al pubblico (classe A); United Kingdom publishes a hospital. 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 |
|---|---|---|---|---|
| Italy | prezzo al pubblico (classe A) | 2 | 3 | EUR███.██ |
| United Kingdom | hospital | 2 | 2 | GBP███.██ |
5 pack listings across 4 brand entries and 2 price bases, refreshed 02 Sep 2026. Ranges span every Dronedarone 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 Dronedarone 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.
2 holders have a Canadian DIN containing Dronedarone, across 2 DINs, of which 1 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 |
|---|---|---|---|---|
| SANOFI-AVENTIS CANADA INC | 1 | 1 | MULTAQ | Sourceable in Canada |
| ASCEND LABORATORIES LTD | 1 | 0 | ASN-DRONEDARONE | 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 | 400 MG |
|---|---|
| Dosage form | TABLET |
| Route | ORAL |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Dronedarone |
|---|---|
| ATC code | C01BD07 |
| 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) | 02514397 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2514397 |
| Brand name | ASN-DRONEDARONE |
| Generic / active ingredient | DRONEDARONE (DRONEDARONE HYDROCHLORIDE) : 400 MG |
| Market authorization holder | ASCEND LABORATORIES LTD |
| Health Canada schedule | Prescription |
| ATC code | C01BD07 |
| ATC anatomical main group | C — Cardiovascular system |
| ATC therapeutic subgroup | C01BD |
| Current status | APPROVED |
| Status date | 29-Mar-2021 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
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
1 of 2 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| MULTAQ | 400 MG | TABLET | SANOFI-AVENTIS CANADA INC | MARKETED | 02330989 |
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.
How can I get it?
This product is approved by Health Canada but not yet marketed in Canada, so there is no Canadian supply to draw on today. Nexara can tell you whether it has been launched, and can look at supply from other markets where a Canadian pack is not required or where importation is 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.