TARO-TRAMADOL/ACET 37.5 MG
TRAMADOL HYDROCHLORIDE : 37.5 MG ACETAMINOPHEN : 325 MG · DIN 02388197 · SUN PHARMA CANADA INC
Health Canada status: MARKETED
What is TARO-TRAMADOL/ACET?
TARO-TRAMADOL/ACET 37.5 MG contains TRAMADOL HYDROCHLORIDE : 37.5 MG ACETAMINOPHEN : 325 MG. It is listed in the Health Canada Drug Product Database under DIN 02388197, held by SUN PHARMA CANADA INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 21-Oct-2021. 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 TARO-TRAMADOL/ACET used for?
Management of moderate to moderately severe pain in adults. Not evaluated beyond 12 weeks.
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 | 02388197 |
|---|---|
| Brand name | TARO-TRAMADOL/ACET |
| Generic / active ingredient | TRAMADOL HYDROCHLORIDE : 37.5 MG ACETAMINOPHEN : 325 MG |
| Manufacturer | SUN PHARMA CANADA INC |
| Strength | 37.5 MG |
| Dosage form | TABLET |
| Route of administration | ORAL |
| Schedule | NARCOTICS (CDSA I) |
| ATC code | N02AJ13 TRAMADOL AND PARACETAMOL |
| AHFS class | 28:08.92 ; 28:08.08 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 21-Oct-2021 |
| Original market date | 2012-10-01 00:00:00 |
How is it administered?
Indicated for moderate to moderately severe pain. Tablets must be swallowed whole. Dosage should be individualized; use lowest effective dose for shortest duration.
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 Section 38). Standard storage is typically 15-30°C.
How is it supplied?
Not explicitly detailed in provided text (refers to Section 38), but typically available in bottles or blisters.
Contraindications
Hypersensitivity to tramadol/acetaminophen; GI obstruction; severe hepatic/renal impairment (CrCl <30ml/min); acute asthma/respiratory depression; pregnancy/nursing; children <12 years.
Warnings and precautions
Serious risks of addiction, abuse, misuse, life-threatening respiratory depression, fatal overdose, and hepatotoxicity (acetaminophen). Risk of seizures and serotonin syndrome.
What can be used instead?
Other Canadian products sharing ATC code N02AJ13 TRAMADOL AND PARACETAMOL. 8 of 24 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-TRAMADOL/ACET | 325 MG | TABLET | APOTEX INC | MARKETED | DIN 02336790 |
| AURO-TRAMADOL/ACETAMINOPHEN | 37.5 MG | TABLET | AURO PHARMA INC | MARKETED | DIN 02439050 |
| JAMP-ACET-TRAMADOL | 325 MG | TABLET | JAMP PHARMA CORPORATION | MARKETED | DIN 02388308 |
| MAR-TRAMADOL/ACET | 37.5 MG | TABLET | MARCAN PHARMACEUTICALS INC | MARKETED | DIN 02388324 |
| MINT-TRAMADOL/ACET | 325 MG | TABLET | MINT PHARMACEUTICALS INC | MARKETED | DIN 02389800 |
| PRZ-TRAMADOL/ACET | 325 MG | TABLET | PHARMARIS CANADA INC | MARKETED | DIN 02551047 |
| TEVA-TRAMADOL/ACETAMINOPHEN | 325 MG | TABLET | TEVA CANADA LIMITED | MARKETED | DIN 02347180 |
| ACT TRAMADOL/ACET | 37.5 MG | TABLET | ACTAVIS PHARMA COMPANY | CANCELLED POST MARKET | DIN 02383209 |
| AG-ACET-TRAMADOL | 325 MG | TABLET | ANGITA PHARMA INC. | APPROVED | DIN 02477092 |
| BIO-TRAMADOL/ACET | 325 MG | TABLET | BIOMED PHARMA | CANCELLED PRE MARKET | DIN 02477122 |
Who else supplies TRAMADOL AND PARACETAMOL worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. TRAMADOL AND PARACETAMOL appears in 695 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.
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.