APO-LABETALOL 100 MG
LABETALOL HYDROCHLORIDE : 100 MG · DIN 02243538 · APOTEX INC
Health Canada status: MARKETED
What is APO-LABETALOL?
APO-LABETALOL 100 MG contains LABETALOL HYDROCHLORIDE : 100 MG. It is listed in the Health Canada Drug Product Database under DIN 02243538, held by APOTEX INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 14-Jul-2020. 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 APO-LABETALOL called?
The same molecule, LABETALOL, 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 |
|---|---|---|
| Trandate | 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.
Product details and regulatory record
| DIN | 02243538 |
|---|---|
| Brand name | APO-LABETALOL |
| Generic / active ingredient | LABETALOL HYDROCHLORIDE : 100 MG |
| Manufacturer | APOTEX INC |
| Strength | 100 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | Prescription |
| ATC code | C07AG01 LABETALOL |
| AHFS class | 24:24.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 14-Jul-2020 |
| Original market date | 2001-03-16 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) | 02243538 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2243538 |
| Brand name | APO-LABETALOL |
| Active ingredient / INN | LABETALOL HYDROCHLORIDE : 100 MG |
| ATC code | C07AG01 |
| ATC anatomical main group | C — Cardiovascular system |
| ATC therapeutic subgroup | C07 |
| AHFS class | 24:24.00 |
| Health Canada schedule | Prescription |
| Biosimilar biologic | No |
| Market authorization holder | APOTEX INC |
Which pack is which?
| Strength on the label | 100 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.
Is LABETALOL in shortage in Canada?
A Canadian shortage report is on file for a product containing this molecule: Active — reported by OMEGA LABORATORIES LIMITED, last seen 04 Sep 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?
Other Canadian products sharing ATC code C07AG01 LABETALOL. 10 of 22 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-LABETALOL | 200 MG | TABLET | APOTEX INC | MARKETED | DIN 02243539 |
| LABETALOL HYDROCHLORIDE INJECTION | 5 MG | SOLUTION | OMEGA LABORATORIES LIMITED | MARKETED | DIN 02457040 |
| LABETALOL HYDROCHLORIDE INJECTION USP | 5 MG | SOLUTION | STERIMAX INC | MARKETED | DIN 02385120 |
| LABETALOL HYDROCHLORIDE INJECTION USP | 5 MG | SOLUTION | JAMP PHARMA CORPORATION | MARKETED | DIN 02541505 |
| LABETALOL HYDROCHLORIDE INJECTION USP | 5 MG | SOLUTION | SANDOZ CANADA INCORPORATED | MARKETED | DIN 02231689 |
| RIVA-LABETALOL | 100 MG | TABLET | LABORATOIRE RIVA INC. | MARKETED | DIN 02489406 |
| RIVA-LABETALOL | 200 MG | TABLET | LABORATOIRE RIVA INC. | MARKETED | DIN 02489414 |
| TRANDATE | 100 MG | TABLET | ENDO OPERATIONS LTD. | MARKETED | DIN 02106272 |
| TRANDATE | 200 MG | TABLET | ENDO OPERATIONS LTD. | MARKETED | DIN 02106280 |
| LABETALOL HYDROCHLORIDE INJECTION | 5 MG | SOLUTION | JUNO PHARMACEUTICALS CORP. | CANCELLED PRE MARKET | DIN 02539101 |
Who else supplies LABETALOL worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. LABETALOL appears in 39 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 LABETALOL cost around the world?
LABETALOL is listed on 5 national price registers Nexara tracks, across 92 pack listings published on 5 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 | 5 | 83 | 03 Sep 2026 |
| United Kingdom | hospital | 5 | 5 | 31 Aug 2026 |
| Australia | ex-manufacturer | 1 | 2 | 08 Sep 2026 |
| United Arab Emirates | public | 1 | 1 | 31 Aug 2026 |
| South Africa | single exit price | 1 | 1 | 01 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?
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.
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.