TRANDATE 200 MG
LABETALOL HYDROCHLORIDE : 200 MG · DIN 02106280 · ENDO OPERATIONS LTD.
Health Canada status: MARKETED
What is TRANDATE?
TRANDATE 200 MG contains LABETALOL HYDROCHLORIDE : 200 MG. It is listed in the Health Canada Drug Product Database under DIN 02106280, held by ENDO OPERATIONS LTD., supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 29-Dec-2025. 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 TRANDATE used for?
Treatment of hypertension. Used alone or in combination with other drugs, particularly thiazide diuretics.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Product details and regulatory record
| DIN | 02106280 |
|---|---|
| Brand name | TRANDATE |
| Generic / active ingredient | LABETALOL HYDROCHLORIDE : 200 MG |
| Manufacturer | ENDO OPERATIONS LTD. |
| Strength | 200 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 | 29-Dec-2025 |
| Original market date | 1996-12-30 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) | 02106280 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2106280 |
| Brand name | TRANDATE |
| Active ingredient / INN | LABETALOL HYDROCHLORIDE : 200 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 | ENDO OPERATIONS LTD. |
How is it administered?
Initial: 100 mg twice daily. Adjust semi-weekly or weekly. Usual maintenance: 200-400 mg twice daily. Max: 1200 mg/day. Take preferably after food. Gradual withdrawal required for angina patients.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in provided text (Section 11 header present but content truncated). Standard practice is 15-30°C.
How is it supplied?
Bottles of 100 tablets.
Which pack is which?
| Strength on the label | 200 MG |
|---|---|
| Dosage form | TABLET |
| Route | ORAL |
| Packaging as described in the monograph | Bottles of 100 tablets. |
| Storage | Not explicitly detailed in provided text (Section 11 header present but content truncated). Standard practice is 15-30°C. |
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.
Contraindications
Hypersensitivity; sinus bradycardia; sick sinus syndrome; uncontrolled congestive heart failure; cardiogenic shock; asthma or history of obstructive lung disease; >1st degree AV block; severe PAD.
Warnings and precautions
Severe hepatocellular injury (may be fatal). Abrupt cessation can exacerbate angina or cause MI. Risk of postural hypotension, bronchospasm, and masking hypoglycemia/thyrotoxicosis symptoms.
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 | 100 MG | TABLET | APOTEX INC | MARKETED | DIN 02243538 |
| 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 | SANDOZ CANADA INCORPORATED | MARKETED | DIN 02231689 |
| LABETALOL HYDROCHLORIDE INJECTION USP | 5 MG | SOLUTION | JAMP PHARMA CORPORATION | MARKETED | DIN 02541505 |
| LABETALOL HYDROCHLORIDE INJECTION USP | 5 MG | SOLUTION | STERIMAX INC | MARKETED | DIN 02385120 |
| 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 |
| 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.