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APO-AZATHIOPRINE 50 MG

AZATHIOPRINE : 50 MG · DIN 02242907 · APOTEX INC

Health Canada status: MARKETED

What is APO-AZATHIOPRINE?

APO-AZATHIOPRINE 50 MG contains AZATHIOPRINE : 50 MG. It is listed in the Health Canada Drug Product Database under DIN 02242907, held by APOTEX INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 17-Oct-2000. 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 APO-AZATHIOPRINE used for?

APO-AZATHIOPRINE (azathioprine tablets) is indicated as an adjunct for the prevention of rejection in renal homotransplantation. APO-AZATHIOPRINE is indicated only in adult patients meeting criteria for classic or definite rheumatoid arthritis as specified by the American Rheumatism Association. APO-AZATHIOPRINE should be restricted to patients with severe, active and erosive disease not responsive to conventional management including rest, acetylsalicylic acid or other non-steroidal drugs, or with disease-modifying antirheumatic drugs (DMARD’s).

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

DIN02242907
Brand nameAPO-AZATHIOPRINE
Generic / active ingredientAZATHIOPRINE : 50 MG
ManufacturerAPOTEX INC
Strength50 MG
Dosage formTABLET
Route of administrationORAL
SchedulePrescription
ATC codeL04AX01 AZATHIOPRINE
AHFS class90:28.00
BiosimilarNo
Health Canada statusMARKETED
Status date17-Oct-2000
Original market date2000-10-17 00:00:00

How is it administered?

Renal Transplant: Initial 3-5 mg/kg daily; maintenance 1-3 mg/kg daily. Rheumatoid Arthritis: Initial 1.0 mg/kg (50-100 mg) daily; may increase by 0.5 mg/kg daily to max 2.5 mg/kg/day.

Included because it drives pack selection and wastage. Consult the monograph.

How is it stored and handled?

null

How is it supplied?

bottles of 100 tablets

Contraindications

Hypersensitivity to azathioprine or any ingredient in the formulation. Patients with a history of hypersensitivity to 6-mercaptopurine should not be prescribed azathioprine.

Warnings and precautions

Mutagenic and carcinogenic; increased risk of neoplasia (lymphoma, skin cancer). Severe leukopenia/thrombocytopenia. Macrophage activation syndrome. Increased susceptibility to infection.

What can be used instead?

Other Canadian products sharing ATC code L04AX01 AZATHIOPRINE. 3 of 14 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.

ProductStrengthFormManufacturerHealth Canada statusDIN
IMURAN50 MGTABLETASPEN PHARMACARE CANADA INC.MARKETEDDIN 00004596
TEVA-AZATHIOPRINE50 MGTABLETTEVA CANADA LIMITEDMARKETEDDIN 02236819
AZATHIOPRINE50 MGTABLETBDH INC.CANCELLED POST MARKETDIN 02235352
AZATHIOPRINE50 MGTABLETSANIS HEALTH INCCANCELLED POST MARKETDIN 02343002
AZATHIOPRINE SODIUM FOR INJECTION100 MGPOWDER FOR SOLUTIONNOVOPHARM LIMITEDCANCELLED PRE MARKETDIN 02231575
AZATHIOPRINE-5050 MGTABLETPRO DOC LIMITEECANCELLED POST MARKETDIN 02243371
IMURAN50 MGPOWDER FOR SOLUTIONASPEN PHARMACARE CANADA INC.DORMANTDIN 02244895
IMURAN INJ 100MG100 MGPOWDER FOR SOLUTIONGLAXO WELLCOME INC.CANCELLED POST MARKETDIN 00337854
MYLAN-AZATHIOPRINE50 MGTABLETMYLAN PHARMACEUTICALS ULCCANCELLED POST MARKETDIN 02231491
NTP-AZATHIOPRINE50 MGTABLETTEVA CANADA LIMITEDCANCELLED PRE MARKETDIN 02358573

Who else supplies AZATHIOPRINE worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. AZATHIOPRINE appears in 113 registered pack listings across 13 markets, published on 10 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 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.

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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.

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Health Canada Drug Product Database (DPD), DIN 02242907. Last reviewed 2026-09-08. Nexara Health is a licensed wholesaler and supplies licensed entities only; consumer orders are routed to a partner pharmacy.