APO-BETAHISTINE 16 MG — DIN 02427974
BETAHISTINE HYDROCHLORIDE : 16 MG · APOTEX INC · TABLET · wholesale supply in Canada
Health Canada status: APPROVED
What is APO-BETAHISTINE?
APO-BETAHISTINE 16 MG contains BETAHISTINE HYDROCHLORIDE : 16 MG. It is listed in the Health Canada Drug Product Database under DIN 02427974, held by APOTEX INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as approved, status dated 11-Jul-2014. 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 Betahistine cost around the world?
Betahistine is listed on 4 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. Greece publishes a producer price (ex-factory); Morocco publishes a PPV (public price); South Africa publishes a single exit price. 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 |
|---|---|---|---|---|
| Greece | producer price (ex-factory) | 11 | 11 | EUR███.██ |
| Morocco | PPV (public price) | 4 | 5 | MAD███.██ |
| United Kingdom | hospital | 3 | 3 | GBP███.██ |
| South Africa | single exit price | 3 | 3 | ZAR███.██ |
22 pack listings across 21 brand entries and 4 price bases, refreshed 05 Sep 2026. Ranges span every Betahistine 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 Betahistine 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.
13 holders have a Canadian DIN containing Betahistine, across 33 DINs, of which 17 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 |
|---|---|---|---|---|
| AURO PHARMA INC | 3 | 3 | AURO-BETAHISTINE | Sourceable in Canada |
| MANTRA PHARMA INC | 3 | 3 | M-BETAHISTINE | Sourceable in Canada |
| MINT PHARMACEUTICALS INC | 3 | 3 | MINT-BETAHISTINE | Sourceable in Canada |
| NORA PHARMA INC | 3 | 3 | NRA-BETAHISTINE | Sourceable in Canada |
| TEVA CANADA LIMITED | 3 | 3 | TEVA-BETAHISTINE | Sourceable in Canada |
| BGP PHARMA ULC | 2 | 2 | SERC | Sourceable in Canada |
| APOTEX INC | 3 | 0 | APO-BETAHISTINE | No marketed DIN |
| SANIS HEALTH INC | 3 | 0 | BETAHISTINE | No marketed DIN |
| SURAX HEALTHCARE INC | 3 | 0 | BETAHISTINE | No marketed DIN |
| ACTAVIS PHARMA COMPANY | 2 | 0 | ACT BETAHISTINE | No marketed DIN |
| PHARMASCIENCE INC | 2 | 0 | PMS-BETAHISTINE | No marketed DIN |
| SOLVAY PHARMA INC | 2 | 0 | SERC - TAB 4MG, SERC 8 MG | 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 | 16 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 | Betahistine |
|---|---|
| ATC code | N07CA01 |
| AHFS class | 28:92.00 |
| 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) | 02427974 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2427974 |
| Brand name | APO-BETAHISTINE |
| Generic / active ingredient | BETAHISTINE HYDROCHLORIDE : 16 MG |
| Market authorization holder | APOTEX INC |
| Health Canada schedule | Prescription |
| ATC code | N07CA01 |
| ATC anatomical main group | N — Nervous system |
| ATC therapeutic subgroup | N07CA |
| Current status | APPROVED |
| Status date | 11-Jul-2014 |
| 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
17 of 33 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| AURO-BETAHISTINE | 24 MG | TABLET | AURO PHARMA INC | MARKETED | 02449161 |
| AURO-BETAHISTINE | 8 MG | TABLET | AURO PHARMA INC | MARKETED | 02449145 |
| AURO-BETAHISTINE | 16 MG | TABLET | AURO PHARMA INC | MARKETED | 02449153 |
| M-BETAHISTINE | 8 MG | TABLET | MANTRA PHARMA INC | MARKETED | 02519682 |
| M-BETAHISTINE | 16 MG | TABLET | MANTRA PHARMA INC | MARKETED | 02519690 |
| M-BETAHISTINE | 24 MG | TABLET | MANTRA PHARMA INC | MARKETED | 02519704 |
| MINT-BETAHISTINE | 8 MG | TABLET | MINT PHARMACEUTICALS INC | MARKETED | 02538121 |
| MINT-BETAHISTINE | 16 MG | TABLET | MINT PHARMACEUTICALS INC | MARKETED | 02538148 |
| MINT-BETAHISTINE | 24 MG | TABLET | MINT PHARMACEUTICALS INC | MARKETED | 02538156 |
| NRA-BETAHISTINE | 8 MG | TABLET | NORA PHARMA INC | MARKETED | 02544911 |
2 · Same class — other molecules in ATC N07CA
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Betahistine | ACT BETAHISTINE · APO-BETAHISTINE · AURO-BETAHISTINE · BETAHISTINE · +9 more | 33 | 17 | Yes |
| Flunarizine | FLUNARIZINE · NOVO-FLUNARIZINE - CAP 5MG · SIBELIUM CAP 5MG | 3 | 1 | Yes |
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.
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 APO-BETAHISTINE called?
The same molecule, Betahistine, 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 |
|---|---|---|
| SERC | Latin | Morocco |
| VERTIS | Latin | Morocco |
| Zygovert | Latin | South Africa |
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?
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.