Nexara Health — Health Canada Drug Establishment Licence #3-002896

APO-QUETIAPINE 25 MG

Last verified 2026-09-08 · Source: Health Canada Drug Product Database (DPD), DIN 02313901

APO-QUETIAPINE 25 MG

QUETIAPINE (QUETIAPINE FUMARATE) : 25 MG · DIN 02313901 · APOTEX INC

Health Canada status: DORMANT

What is APO-QUETIAPINE?

APO-QUETIAPINE 25 MG contains QUETIAPINE (QUETIAPINE FUMARATE) : 25 MG. It is listed in the Health Canada Drug Product Database under DIN 02313901, held by APOTEX INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as dormant, status dated 08-Jul-2022. 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-QUETIAPINE used for?

Management of the manifestations of schizophrenia; monotherapy for the acute management of manic episodes associated with bipolar disorder.

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

DIN02313901
Brand nameAPO-QUETIAPINE
Generic / active ingredientQUETIAPINE (QUETIAPINE FUMARATE) : 25 MG
ManufacturerAPOTEX INC
Strength25 MG
Dosage formTABLET
Route of administrationORAL
SchedulePrescription
ATC codeN05AH04 QUETIAPINE
AHFS class28:16.08.04
BiosimilarNo
Health Canada statusDORMANT
Status date08-Jul-2022
Original market date2008-09-04 00:00:00

How is it administered?

Schizophrenia: Titrate from 25 mg BID to target 300 mg/day by day 4-7. Bipolar Mania: Titrate from 100 mg/day on Day 1 to 400-800 mg/day by Day 6. Administer with or without food.

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

How is it stored and handled?

Store at 15-30°C. (Note: General standard, though specific section 11 text was truncated in snippet, section 10.3/11 headers exist).

How is it supplied?

Bottles of 100 and 500 tablets; blister packages of 30 tablets.

Contraindications

Hypersensitivity to quetiapine or to any ingredient in the formulation or component of the container.

Warnings and precautions

Increased mortality in elderly patients with dementia. Risk of Neuroleptic Malignant Syndrome, Tardive Dyskinesia, hyperglycemia, lipid changes, weight gain, and orthostatic hypotension.

Is QUETIAPINE in shortage in Canada?

A Canadian shortage report is on file for this molecule: Active — reported by JAMP PHARMA CORPORATION (Tier 3 Drug Shortages About & Resources), 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.

Check availability for APO-QUETIAPINE

What can be used instead?

Other Canadian products sharing ATC code N05AH04 QUETIAPINE. 93 of 236 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
ACH-QUETIAPINE100 MGTABLET (IMMEDIATE RELEASE)ACCORD HEALTHCARE INCMARKETEDDIN 02387808
ACH-QUETIAPINE150 MGTABLET (IMMEDIATE RELEASE)ACCORD HEALTHCARE INCMARKETEDDIN 02387816
ACH-QUETIAPINE200 MGTABLET (IMMEDIATE RELEASE)ACCORD HEALTHCARE INCMARKETEDDIN 02387824
ACH-QUETIAPINE25 MGTABLET (IMMEDIATE RELEASE)ACCORD HEALTHCARE INCMARKETEDDIN 02387794
ACH-QUETIAPINE300 MGTABLET (IMMEDIATE RELEASE)ACCORD HEALTHCARE INCMARKETEDDIN 02387832
ACH-QUETIAPINE FUMARATE XR150 MGTABLET (EXTENDED-RELEASE)ACCORD HEALTHCARE INCMARKETEDDIN 02450879
ACH-QUETIAPINE FUMARATE XR200 MGTABLET (EXTENDED-RELEASE)ACCORD HEALTHCARE INCMARKETEDDIN 02450887
ACH-QUETIAPINE FUMARATE XR300 MGTABLET (EXTENDED-RELEASE)ACCORD HEALTHCARE INCMARKETEDDIN 02450895
ACH-QUETIAPINE FUMARATE XR400 MGTABLET (EXTENDED-RELEASE)ACCORD HEALTHCARE INCMARKETEDDIN 02450909
ACH-QUETIAPINE FUMARATE XR50 MGTABLET (EXTENDED-RELEASE)ACCORD HEALTHCARE INCMARKETEDDIN 02450860

Who else supplies QUETIAPINE worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. QUETIAPINE appears in 7122 registered pack listings across 11 markets, published on 8 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.

Request a quote for APO-QUETIAPINE

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.

Related pages

Sourcing this product