SOTALOL 160 MG
SOTALOL HYDROCHLORIDE : 160 MG · DIN 02163772 · APOTEX INC
Health Canada status: APPROVED
What is SOTALOL?
SOTALOL 160 MG contains SOTALOL HYDROCHLORIDE : 160 MG. It is listed in the Health Canada Drug Product Database under DIN 02163772, held by APOTEX INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as approved, status dated 07-Dec-2021. 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 else is SOTALOL called?
The same molecule, SOTALOL, 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 |
|---|---|---|
| Sotacor | Latin | Australia, South Africa |
| APX-Sotalol | Latin | Australia |
| Cardol | Latin | Australia |
| Solavert | Latin | Australia |
| Sotalol Sandoz | Latin | Australia |
| SOTALOL-WGR | Latin | Australia |
| SOTALEX | Latin | Morocco |
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.
Product details and regulatory record
| DIN | 02163772 |
|---|---|
| Brand name | SOTALOL |
| Generic / active ingredient | SOTALOL HYDROCHLORIDE : 160 MG |
| Manufacturer | APOTEX INC |
| Strength | 160 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | C07AA07 SOTALOL |
| AHFS class | 28:08.08 |
| Biosimilar | No |
| Health Canada status | APPROVED |
| Status date | 07-Dec-2021 |
| Original market date | 1995-12-31 00:00:00 |
How is this product identified?
Purchase orders, customs paperwork and tender documents each ask for a different identifier, and a DIN written without its leading zeros is the single most common reason an order line fails to match. Every form Nexara accepts for this product is listed here.
| DIN (8-digit, as used in Nexara ordering) | 02163772 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2163772 |
| Brand name | SOTALOL |
| Active ingredient / INN | SOTALOL HYDROCHLORIDE : 160 MG |
| ATC code | C07AA07 |
| ATC anatomical main group | C — Cardiovascular system |
| ATC therapeutic subgroup | C07 |
| AHFS class | 28:08.08 |
| Health Canada schedule | Prescription |
| Biosimilar biologic | No |
| Market authorization holder | APOTEX INC |
Which pack is which?
| Strength on the label | 160 MG |
|---|---|
| Dosage form | TABLET |
| Route | ORAL |
One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced. Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
What can be used instead?
Other Canadian products sharing ATC code C07AA07 SOTALOL. 3 of 55 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.
| Product | Strength | Form | Manufacturer | Health Canada status | DIN |
|---|---|---|---|---|---|
| APO-SOTALOL | 160 MG | TABLET | APOTEX INC | MARKETED | DIN 02167794 |
| APO-SOTALOL | 80 MG | TABLET | APOTEX INC | MARKETED | DIN 02210428 |
| PMS-SOTALOL - 80 MG | 80 MG | TABLET | PHARMASCIENCE INC | MARKETED | DIN 02238326 |
| AVA-SOTALOL | 160 MG | TABLET | AVANSTRA INC | CANCELLED POST MARKET | DIN 02363682 |
| AVA-SOTALOL | 80 MG | TABLET | AVANSTRA INC | CANCELLED POST MARKET | DIN 02363674 |
| CO SOTALOL | 160 MG | TABLET | COBALT PHARMACEUTICALS COMPANY | CANCELLED POST MARKET | DIN 02270633 |
| CO SOTALOL | 80 MG | TABLET | COBALT PHARMACEUTICALS COMPANY | CANCELLED POST MARKET | DIN 02270625 |
| DOM-SOTALOL | 160 MG | TABLET | DOMINION PHARMACAL | CANCELLED POST MARKET | DIN 02238635 |
| DOM-SOTALOL | 80 MG | TABLET | DOMINION PHARMACAL | CANCELLED POST MARKET | DIN 02238634 |
| FTP-SOTALOL | 160 MG | TABLET | FTP-PHARMACAL INC. | CANCELLED POST MARKET | DIN 02238615 |
Who else supplies SOTALOL worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. SOTALOL appears in 97 registered pack listings across 9 markets, published on 7 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.
Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.
How much does SOTALOL cost around the world?
SOTALOL is listed on 8 national price registers Nexara tracks, across 54 pack listings published on 7 different price bases. What each country publishes is set out below.
| Market | What that country publishes | Brands listed | Pack listings | As of |
|---|---|---|---|---|
| United States | acquisition | 4 | 28 | 03 Sep 2026 |
| Australia | ex-manufacturer | 6 | 12 | 08 Sep 2026 |
| Romania | max producer price | 3 | 4 | 03 Sep 2026 |
| United Kingdom | hospital | 3 | 3 | 31 Aug 2026 |
| South Africa | single exit price | 1 | 3 | 01 Sep 2026 |
| Greece | producer price (ex-factory) | 2 | 2 | 03 Sep 2026 |
| Hungary | producer price (ex-factory) | 1 | 1 | 03 Sep 2026 |
| Morocco | PPV (public price) | 1 | 1 | 05 Sep 2026 |
Why there are no figures here. These bases are not comparable. A Brazilian ex-factory ceiling, a Belgian pharmacy public price and a Japanese reimbursement rate answer three different questions, and none of them is what a product lands in Canada for. Putting them side by side would mislead in both directions, so Nexara publishes where a molecule is listed and on what basis, and quotes the delivered Canadian price per order.
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.
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.
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.