APO-AMPHETAMINE XR 5 MG — DIN 02445492
MIXED SALTS AMPHETAMINE : 5 MG · APOTEX INC · CAPSULE (EXTENDED RELEASE) · wholesale supply in Canada
Health Canada status: MARKETED
What is APO-AMPHETAMINE XR?
APO-AMPHETAMINE XR 5 MG contains MIXED SALTS AMPHETAMINE : 5 MG. It is listed in the Health Canada Drug Product Database under DIN 02445492, held by APOTEX INC, supplied as CAPSULE (EXTENDED RELEASE) for ORAL administration. Health Canada currently lists it as marketed, status dated 15-Apr-2019. 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-AMPHETAMINE XR used for?
Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children (6-12), adolescents (13-17), and adults (18+).
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Is there a generic Amfetamine 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.
7 holders have a Canadian DIN containing Amfetamine, across 41 DINs, of which 22 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 | 6 | 6 | APO-AMPHETAMINE XR | Sourceable in Canada |
| TAKEDA CANADA INC | 6 | 6 | ADDERALL XR | Sourceable in Canada |
| TEVA CANADA LIMITED | 6 | 6 | TEVA-AMPHETAMINE XR | Sourceable in Canada |
| KYE PHARMACEUTICALS INC. | 5 | 4 | DYANAVEL XR | Sourceable in Canada |
| PHARMASCIENCE INC | 6 | 0 | PMS-AMPHETAMINES XR | No marketed DIN |
| SANDOZ CANADA INCORPORATED | 6 | 0 | SANDOZ AMPHETAMINE XR | No marketed DIN |
| SUN PHARMA CANADA INC | 6 | 0 | TARO-AMPHETAMINE XR | 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 | CAPSULE (EXTENDED RELEASE) |
| Route | ORAL |
| Pack configuration (monograph) | Bottles of 100 capsules. |
| Storage | Not explicitly detailed in provided text snippet (refer to section 11 of full monograph). |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Amfetamine |
|---|---|
| ATC code | N06BA01 |
| AHFS class | 28:20.04 |
| 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) | 02445492 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2445492 |
| Brand name | APO-AMPHETAMINE XR |
| Generic / active ingredient | MIXED SALTS AMPHETAMINE : 5 MG |
| Market authorization holder | APOTEX INC |
| Health Canada schedule | CONTROLLED DRUGS (CDSA I) |
| ATC code | N06BA01 |
| ATC anatomical main group | N — Nervous system |
| ATC therapeutic subgroup | N06BA |
| Current status | MARKETED |
| Status date | 15-Apr-2019 |
| Original market date | 2019-04-15 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Once daily in the morning. Children (6-12): Start 10 mg (max 30 mg). Adolescents/Adults: Start 10 mg (usual max 20 mg, absolute max 30 mg). Swallow whole or sprinkle on applesauce.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to amphetamines, advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, glaucoma, agitated states, history of drug abuse.
Warnings and precautions
Potential for abuse/misuse. Misuse may cause serious cardiovascular events/sudden death. Risk of QTc prolongation. Monitor blood pressure and heart rate.
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
22 of 41 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| ADDERALL XR | 20 MG | CAPSULE (EXTENDED RELEASE) | TAKEDA CANADA INC | MARKETED | 02248811 |
| ADDERALL XR | 5 MG | CAPSULE (EXTENDED RELEASE) | TAKEDA CANADA INC | MARKETED | 02248808 |
| ADDERALL XR | 25 MG | CAPSULE (EXTENDED RELEASE) | TAKEDA CANADA INC | MARKETED | 02248812 |
| ADDERALL XR | 10 MG | CAPSULE (EXTENDED RELEASE) | TAKEDA CANADA INC | MARKETED | 02248809 |
| ADDERALL XR | 30 MG | CAPSULE (EXTENDED RELEASE) | TAKEDA CANADA INC | MARKETED | 02248813 |
| ADDERALL XR | 15 MG | CAPSULE (EXTENDED RELEASE) | TAKEDA CANADA INC | MARKETED | 02248810 |
| APO-AMPHETAMINE XR | 15 MG | CAPSULE (EXTENDED RELEASE) | APOTEX INC | MARKETED | 02445514 |
| APO-AMPHETAMINE XR | 10 MG | CAPSULE (EXTENDED RELEASE) | APOTEX INC | MARKETED | 02445506 |
| APO-AMPHETAMINE XR | 20 MG | CAPSULE (EXTENDED RELEASE) | APOTEX INC | MARKETED | 02445522 |
| APO-AMPHETAMINE XR | 25 MG | CAPSULE (EXTENDED RELEASE) | APOTEX INC | MARKETED | 02445530 |
2 · Same class — other molecules in ATC N06BA
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Lisdexamfetamine | AG-LISDEXAMFETAMINE · APO-LISDEXAMFETAMINE · APO-LISDEXAMFETAMINE CAPSULES · APO-LISDEXAMFETAMINE CHEWABLE TABLETS · +7 more | 87 | 66 | Yes |
| Atomoxetine | AG-ATOMOXETINE · APO-ATOMOXETINE · ATOMOXETINE · AURO-ATOMOXETINE · +9 more | 96 | 57 | Yes |
| Methylphenidate | ACT METHYLPHENIDATE ER · APO-METHYLPHENIDATE · APO-METHYLPHENIDATE CR · APO-METHYLPHENIDATE ER · +25 more | 103 | 55 | Yes |
| Amfetamine | ADDERALL XR · APO-AMPHETAMINE XR · DYANAVEL XR · PMS-AMPHETAMINES XR · +3 more | 41 | 22 | Yes |
| Modafinil | ALERTEC · APO-MODAFINIL · AURO-MODAFINIL · BIO-MODAFINIL · +6 more | 10 | 7 | Yes |
| Dexamfetamine | APO-DEXTROAMPHETAMINE SR · DEXEDRINE · DEXEDRINE SPANSULE · DEXTROAMPHETAMINE · +2 more | 9 | 6 | Yes |
| Solriamfetol | SUNOSI | 2 | 2 | Yes |
| Dexmethylphenidate | ATTENADE | 3 | 0 | Not in Canada |
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 N06B
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| N06BC | Caffeine | 11 | 3 |
| N06BX | Idebenone · Other Psychostimulants | 3 | 0 |
4 · Fixed-dose combinations with Canadian supply
| Product | Active ingredients | Holder | Status | DIN |
|---|---|---|---|---|
| DYANAVEL XR | AMPHETAMINE (AMPHETAMINE (COMPLEXED WITH SODIUM POLYSTYRENE SULFONATE), AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE) : 5 MG | KYE PHARMACEUTICALS INC. | MARKETED | 02559803 |
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.
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.