APO-OXYCODONE/ACET 325 MG
ACETAMINOPHEN : 325 MG OXYCODONE HYDROCHLORIDE : 5 MG · DIN 02324628 · APOTEX INC
Health Canada status: MARKETED
What is APO-OXYCODONE/ACET?
APO-OXYCODONE/ACET 325 MG contains ACETAMINOPHEN : 325 MG OXYCODONE HYDROCHLORIDE : 5 MG. It is listed in the Health Canada Drug Product Database under DIN 02324628, held by APOTEX INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 22-May-2009. 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-OXYCODONE/ACET used for?
Relief of moderate to moderately severe pain, including conditions accompanied by fever, in adults. Not indicated for as-needed (prn) use.
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 | 02324628 |
|---|---|
| Brand name | APO-OXYCODONE/ACET |
| Generic / active ingredient | ACETAMINOPHEN : 325 MG OXYCODONE HYDROCHLORIDE : 5 MG |
| Manufacturer | APOTEX INC |
| Strength | 325 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | NARCOTICS (CDSA I) |
| ATC code | N02AJ17 OXYCODONE AND PARACETAMOL |
| AHFS class | 28:08.92 ; 28:08.08 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 22-May-2009 |
| Original market date | 2009-04-15 00:00:00 |
How is it administered?
Individualize dose. Not for as-needed use. Swallow whole; do not crush/chew. Use lowest effective dose for shortest duration. Monitor for respiratory depression.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Not explicitly detailed in provided text (refers to STORAGE AND STABILITY section).
How is it supplied?
Not explicitly detailed in provided text (refers to DOSAGE FORMS, COMPOSITION AND PACKAGING section).
Contraindications
Hypersensitivity to ingredients; severe hepatic insufficiency; GI obstruction; asthma; respiratory depression; acute alcoholism; head injury; MAO inhibitors use; pregnancy/nursing.
Warnings and precautions
Risks of addiction, abuse, misuse, and fatal overdose. Life-threatening respiratory depression. Neonatal Opioid Withdrawal Syndrome. Avoid alcohol and benzodiazepines.
What can be used instead?
Other Canadian products sharing ATC code N02AJ17 OXYCODONE AND PARACETAMOL. 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.
| Product | Strength | Form | Manufacturer | Health Canada status | DIN |
|---|---|---|---|---|---|
| RIVACOCET | 325 MG | TABLET | LABORATOIRE RIVA INC. | MARKETED | DIN 02242468 |
| TEVA-OXYCOCET | 325 MG | TABLET | TEVA CANADA LIMITED | MARKETED | DIN 00608165 |
| ENDOCET | 5 MG | TABLET | BRISTOL-MYERS SQUIBB CANADA | CANCELLED POST MARKET | DIN 01916548 |
| NTP-OXYCODONE ACETAMINOPHEN | 5 MG | TABLET | NT PHARMA CANADA LTD | CANCELLED PRE MARKET | DIN 02346141 |
| NU-OXYCODONE/ACET | 5 MG | TABLET | NU-PHARM INC | CANCELLED (UNRETURNED ANNUAL) | DIN 02336391 |
| OXYCODONE-ACET | 5 MG | TABLET | PRO DOC LIMITEE | CANCELLED POST MARKET | DIN 02327171 |
| OXYCODONE/ACET | 325 MG | TABLET | SANIS HEALTH INC | CANCELLED POST MARKET | DIN 02361361 |
| OXYCODONE/ACETAMINOPHEN | 325 MG | TABLET | NT PHARMA CANADA LTD | CANCELLED PRE MARKET | DIN 02359774 |
| PERCOCET | 325 MG | TABLET | BRISTOL-MYERS SQUIBB CANADA | CANCELLED POST MARKET | DIN 01916475 |
| PERCOCET-DEMI | 325 MG | TABLET | BRISTOL-MYERS SQUIBB CANADA | CANCELLED POST MARKET | DIN 01916491 |
Who else supplies OXYCODONE AND PARACETAMOL worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. OXYCODONE AND PARACETAMOL appears in 240 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 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.