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

Methadone Hydrochloride — products, DINs, and Canadian availability

This page lists Health Canada–registered pharmaceutical products whose active ingredient list includes Methadone Hydrochloride. We track 39 distinct Drug Identification Numbers (DINs) for this molecule, of which 20 are currently in marketed status. Across those registrations there are 14 manufacturers or marketing authorization holders, 3 dosage forms, and 4 distinct strength presentations.

Procurement teams normally arrive here for one of three reasons: a specific brand is unavailable and an equivalent registration is needed; a clinical protocol requires a comparator containing Methadone Hydrochloride in a defined strength; or a pharmacy needs to know which manufacturers still hold an active Canadian registration before committing to a substitution. The table below answers the first question directly. For the second and third, Nexara Health can confirm live availability, remaining shelf life, and landed cost from Canadian stock or from any of more than 40 regulated international source markets.

Registration status is not the same as availability. A product can hold marketed status in the Drug Product Database and still be on allocation, discontinued by the holder, or unavailable in the pack size a hospital needs. Where a Methadone Hydrochloride product is in shortage, our Canadian drug shortage tracker carries the reported status, the reason where the manufacturer has published one, and the marketed alternatives sharing the same active ingredient.

Dosage forms and strengths recorded for Methadone Hydrochloride

Dosage forms: Tablet, Solution, Drops. Strengths: 5 MG, 10 MG, 25 MG, 1 MG.

Manufacturers and marketing authorization holders

APOTEX INC, EUROVET ANIMAL HEALTH B.V., BAUSCH HEALTH, CANADA INC., HOECHST CANADA INC., HOECHST ROUSSEL CANADA INC., VALEO PHARMA INC, JAMP PHARMA CORPORATION, KNIGHT THERAPEUTICS INC., PALADIN PHARMA INC., STERINOVA INC., MALLINCKRODT CANADA ULC, ODAN LABORATORIESLTD, ENDO OPERATIONS LTD., PHARMASCIENCE INC.

Registered products containing Methadone Hydrochloride

DINProductManufacturerStrengthDosage formStatus
02533650APO-METHADONEAPOTEX INC5 MGTabletMarketed
02533669APO-METHADONEAPOTEX INC10 MGTabletMarketed
02533677APO-METHADONEAPOTEX INC25 MGTabletMarketed
02533642APO-METHADONEAPOTEX INC1 MGTabletMarketed
02496658COMFORTANEUROVET ANIMAL HEALTH B.V.10 MGSolutionMarketed
02224577COPHYLACBAUSCH HEALTH, CANADA INC.10 MGDropsDormant
00116343COPHYLACHOECHST CANADA INC.10 MGDropsCancelled Post Market
01987577COPHYLAC DROPSHOECHST ROUSSEL CANADA INC.10 MGDropsCancelled Post Market
00116351COPHYLAC EXPECTORANTHOECHST CANADA INC.10 MGDropsCancelled Post Market
02224585COPHYLAC EXPECTORANT DROPSVALEO PHARMA INC10 MGDropsCancelled Post Market
01987801COPHYLAC EXPECTORANT DROPSHOECHST ROUSSEL CANADA INC.10 MGDropsCancelled Post Market
02495783JAMP METHADONE ORAL CONCENTRATEJAMP PHARMA CORPORATION10 MGSolutionMarketed
02247699METADOLKNIGHT THERAPEUTICS INC.5 MGTabletMarketed
02247698METADOLKNIGHT THERAPEUTICS INC.1 MGTabletMarketed
02247700METADOLKNIGHT THERAPEUTICS INC.10 MGTabletMarketed
02241377METADOLKNIGHT THERAPEUTICS INC.10 MGSolutionMarketed
02247694METADOLKNIGHT THERAPEUTICS INC.1 MGSolutionMarketed
02247701METADOLKNIGHT THERAPEUTICS INC.25 MGTabletMarketed
02247374METADOL-DKNIGHT THERAPEUTICS INC.1 MGSolutionMarketed
02247693METADOL-DPALADIN PHARMA INC.1 MGTabletCancelled Pre Market
02247697METADOL-DPALADIN PHARMA INC.25 MGTabletCancelled Pre Market
02247696METADOL-DPALADIN PHARMA INC.10 MGTabletCancelled Pre Market
02247695METADOL-DPALADIN PHARMA INC.5 MGTabletCancelled Pre Market
02244290METADOL-DKNIGHT THERAPEUTICS INC.10 MGSolutionMarketed
02481979METHADONE HYDROCHLORIDE ORAL CONCENTRATE USPSTERINOVA INC.10 MGSolutionApproved
02394596METHADOSEMALLINCKRODT CANADA ULC10 MGSolutionMarketed
02394618METHADOSEMALLINCKRODT CANADA ULC10 MGSolutionMarketed
02495880ODAN-METHADONEODAN LABORATORIESLTD10 MGSolutionMarketed
02495872ODAN-METHADONEODAN LABORATORIESLTD10 MGSolutionMarketed
02388391PMS-METHADONEENDO OPERATIONS LTD.5 MGTabletCancelled Pre Market
02388405PMS-METHADONEENDO OPERATIONS LTD.10 MGTabletCancelled Pre Market
02388383PMS-METHADONEENDO OPERATIONS LTD.1 MGTabletCancelled Pre Market
02388413PMS-METHADONEENDO OPERATIONS LTD.25 MGTabletCancelled Pre Market
02552728PMS-METHADONE HYDROCHLORIDE ORAL CONCENTRATEPHARMASCIENCE INC10 MGSolutionMarketed
02552736PMS-METHADONE HYDROCHLORIDE ORAL CONCENTRATEPHARMASCIENCE INC10 MGSolutionMarketed
02572052PMS-METHADONE TABLETSPHARMASCIENCE INC1 MGTabletApproved
02572060PMS-METHADONE TABLETSPHARMASCIENCE INC5 MGTabletApproved
02572079PMS-METHADONE TABLETSPHARMASCIENCE INC10 MGTabletApproved
02572087PMS-METHADONE TABLETSPHARMASCIENCE INC25 MGTabletApproved

Sourcing Methadone Hydrochloride through a licensed wholesaler

Nexara Health imports and distributes under Health Canada Drug Establishment Licence #3-002896. For Methadone Hydrochloride we can quote Canadian-marketed presentations, equivalent registrations from the EU, UK, US, Switzerland, Australia, and Japan where the Canadian presentation is unavailable, and comparator-grade supply with Certificate of Analysis, batch and expiry records, and full chain of custody for clinical trial use. Cold-chain presentations ship under GDP conditions with continuous temperature monitoring.

Request a quote

Nexara Health is a Health Canada–licensed pharmaceutical wholesaler (DEL #3-002896) based in Winnipeg, Manitoba, supplying hospitals, pharmacies, clinics, CROs, and trial sponsors across Canada. Send us the product, strength, presentation, and quantity for Methadone Hydrochloride and we will come back with availability, source market, lead time, and landed cost — usually within 24 hours.

Request a sourcing quote or call +1 (431) 588-9055.

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