LABETALOL HYDROCHLORIDE INJECTION 5 MG — DIN 02457040
LABETALOL HYDROCHLORIDE : 5 MG · OMEGA LABORATORIES LIMITED · SOLUTION · wholesale supply in Canada
Health Canada status: MARKETED
What is LABETALOL HYDROCHLORIDE INJECTION?
LABETALOL HYDROCHLORIDE INJECTION 5 MG contains LABETALOL HYDROCHLORIDE : 5 MG. It is listed in the Health Canada Drug Product Database under DIN 02457040, held by OMEGA LABORATORIES LIMITED, supplied as SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 02-Jun-2018. 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 LABETALOL HYDROCHLORIDE INJECTION used for?
Labetalol Hydrochloride Injection is indicated for the emergency treatment of severe hypertension when prompt and urgent reduction of blood pressure is essential.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Labetalol cost around the world?
Labetalol 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. Australia publishes a ex-manufacturer; South Africa publishes a single exit price; United Arab Emirates publishes a public. 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 |
|---|---|---|---|---|
| United States | acquisition | 5 | 83 | USD███.██ |
| United Kingdom | hospital | 5 | 5 | GBP███.██ |
| Australia | ex-manufacturer | 1 | 2 | AUD███.██ |
| United Arab Emirates | public | 1 | 1 | AED███.██ |
| South Africa | single exit price | 1 | 1 | ZAR███.██ |
92 pack listings across 13 brand entries and 5 price bases, refreshed 08 Sep 2026. Ranges span every Labetalol 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 Labetalol 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.
15 holders have a Canadian DIN containing Labetalol, across 22 DINs, of which 10 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 |
|---|---|---|---|---|
| APOTEX INC | 2 | 2 | APO-LABETALOL | Sourceable in Canada |
| ENDO OPERATIONS LTD. | 2 | 2 | TRANDATE | Sourceable in Canada |
| LABORATOIRE RIVA INC. | 2 | 2 | RIVA-LABETALOL | Sourceable in Canada |
| JAMP PHARMA CORPORATION | 1 | 1 | LABETALOL HYDROCHLORIDE INJECTION USP | Sourceable in Canada |
| OMEGA LABORATORIES LIMITED | 1 | 1 | LABETALOL HYDROCHLORIDE INJECTION | Sourceable in Canada |
| SANDOZ CANADA INCORPORATED | 1 | 1 | LABETALOL HYDROCHLORIDE INJECTION USP | Sourceable in Canada |
| STERIMAX INC | 1 | 1 | LABETALOL HYDROCHLORIDE INJECTION USP | Sourceable in Canada |
| GLAXO CANADA INC | 3 | 0 | TRANDATE INJ 5MG/ML, TRANDATE TAB 100MG, TRANDATE TAB 200MG | No marketed DIN |
| HIKMA CANADA LIMITED | 2 | 0 | LABETALOL HYDROCHLORIDE INJECTION IN 0.72% SODIUM CHLORIDE, LABETALOL HYDROCHLORIDE INJECTION IN 5% DEXTROSE | No marketed DIN |
| MINT PHARMACEUTICALS INC | 2 | 0 | MINT-LABETALOL | No marketed DIN |
| MYLAN PHARMACEUTICALS ULC | 1 | 0 | LABETALOL HYDROCHLORIDE INJECTION, USP | No marketed DIN |
| PFIZER CANADA ULC | 1 | 0 | LABETALOL HYDROCHLORIDE INJECTION USP | 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 | 5 MG |
|---|---|
| Dosage form | SOLUTION |
| Route | INTRAVENOUS |
| Pack configuration (monograph) | null |
| Storage | null |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Labetalol |
|---|---|
| ATC code | C07AG01 |
| AHFS class | 24:12.12 |
| 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) | 02457040 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2457040 |
| Brand name | LABETALOL HYDROCHLORIDE INJECTION |
| Generic / active ingredient | LABETALOL HYDROCHLORIDE : 5 MG |
| Market authorization holder | OMEGA LABORATORIES LIMITED |
| Health Canada schedule | Prescription |
| ATC code | C07AG01 |
| ATC anatomical main group | C — Cardiovascular system |
| ATC therapeutic subgroup | C07AG |
| Current status | MARKETED |
| Status date | 02-Jun-2018 |
| Original market date | 2021-07-13 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
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?
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
10 of 22 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| APO-LABETALOL | 100 MG | TABLET | APOTEX INC | MARKETED | 02243538 |
| APO-LABETALOL | 200 MG | TABLET | APOTEX INC | MARKETED | 02243539 |
| LABETALOL HYDROCHLORIDE INJECTION USP | 5 MG | SOLUTION | STERIMAX INC | MARKETED | 02385120 |
| LABETALOL HYDROCHLORIDE INJECTION USP | 5 MG | SOLUTION | JAMP PHARMA CORPORATION | MARKETED | 02541505 |
| LABETALOL HYDROCHLORIDE INJECTION USP | 5 MG | SOLUTION | SANDOZ CANADA INCORPORATED | MARKETED | 02231689 |
| RIVA-LABETALOL | 100 MG | TABLET | LABORATOIRE RIVA INC. | MARKETED | 02489406 |
| RIVA-LABETALOL | 200 MG | TABLET | LABORATOIRE RIVA INC. | MARKETED | 02489414 |
| TRANDATE | 200 MG | TABLET | ENDO OPERATIONS LTD. | MARKETED | 02106280 |
| TRANDATE | 100 MG | TABLET | ENDO OPERATIONS LTD. | MARKETED | 02106272 |
| LABETALOL HYDROCHLORIDE INJECTION | 5 MG | SOLUTION | JUNO PHARMACEUTICALS CORP. | CANCELLED PRE MARKET | 02539101 |
2 · Same class — other molecules in ATC C07AG
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Carvedilol | APO-CARVEDILOL · AURO-CARVEDILOL · AVA-CARVEDILOL · CARVEDILOL · +20 more | 77 | 28 | Yes |
| Labetalol | APO-LABETALOL · LABETALOL HYDROCHLORIDE INJECTION · LABETALOL HYDROCHLORIDE INJECTION IN 0.72% SODIUM CHLORIDE · LABETALOL HYDROCHLORIDE INJECTION IN 5% DEXTROSE · +9 more | 22 | 10 | 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.
3 · Adjacent classes in ATC C07A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| C07AB | Acebutolol · Atenolol · Bisoprolol · Esmolol · Landiolol · +2 more | 305 | 99 |
| C07AA | Nadolol · Oxprenolol · Pindolol · Propranolol · Sotalol · +1 more | 177 | 27 |
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 LABETALOL HYDROCHLORIDE INJECTION 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.
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. 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.