METHYLENE BLUE INJECTION USP 10 MG — DIN 02431548
METHYLENE BLUE : 10 MG · HIKMA CANADA LIMITED · SOLUTION · wholesale supply in Canada
Health Canada status: CANCELLED POST MARKET
What is METHYLENE BLUE INJECTION USP?
METHYLENE BLUE INJECTION USP 10 MG contains METHYLENE BLUE : 10 MG. It is listed in the Health Canada Drug Product Database under DIN 02431548, held by HIKMA CANADA LIMITED, supplied as SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as cancelled post market, status dated 20-Jan-2026. This Drug Identification Number is no longer authorized for sale in Canada, so Nexara does not supply it. The record is kept here because buyers still meet the number on old formularies, purchase orders and tender documents; Nexara can help identify an authorized alternative.
What is METHYLENE BLUE INJECTION USP used for?
Treatment of methemoglobinemia. Also used as a bacteriological stain, dye for fistula detection, and tissue delineation during surgery.
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 Methylthioninium Chloride 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.
11 holders have a Canadian DIN containing Methylthioninium Chloride, across 11 DINs, of which 2 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 |
|---|---|---|---|---|
| OMEGA LABORATORIES LIMITED | 1 | 1 | METHYLENE BLUE INJECTION USP | Sourceable in Canada |
| PHEBRA PTY LTD | 1 | 1 | METHYLENE BLUE INJECTION | Sourceable in Canada |
| ALLEN & HANBURYS A GLAXO CANADA LTD. CO. | 1 | 0 | METHYLENE BLUE INJ 1% | No marketed DIN |
| ALVEDA PHARMACEUTICALS INC | 1 | 0 | METHYLENE BLUE INJECTION USP | No marketed DIN |
| DAVID BULL LABORATORIES (PTY) LTD. | 1 | 0 | METHYLENE BLUE INJ 1% USP | No marketed DIN |
| GLAXO CANADA INC | 1 | 0 | METHYLENE BLUE INJ 10MG/ML USP | No marketed DIN |
| HIKMA CANADA LIMITED | 1 | 0 | METHYLENE BLUE INJECTION USP | No marketed DIN |
| HOSPIRA HEALTHCARE ULC | 1 | 0 | METHYLENE BLUE INJECTION, USP | No marketed DIN |
| LABORATOIRE ATLAS INC | 1 | 0 | METHYLENE BLEU LIQ 2% | No marketed DIN |
| MYLAN PHARMACEUTICALS ULC | 1 | 0 | METHYLENE BLUE INJECTION, USP | No marketed DIN |
| SANDOZ CANADA INCORPORATED | 1 | 0 | METHYLENE BLUE INJECTION USP | 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 | 10 MG |
|---|---|
| Dosage form | SOLUTION |
| Route | INTRAVENOUS |
| Pack configuration (monograph) | Ampoules of 5 mL, boxes of 5. |
| Storage | Store at room temperature (15 to 30°C). |
Pack detail is kept as a regulatory record. This DIN is no longer authorized for sale in Canada, so Nexara does not quote this pack.
Substance and classification
| Active substance | Methylthioninium Chloride |
|---|---|
| ATC code | V03AB17 |
| AHFS class | 91:00.00 |
| 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) | 02431548 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2431548 |
| Brand name | METHYLENE BLUE INJECTION USP |
| Generic / active ingredient | METHYLENE BLUE : 10 MG |
| Market authorization holder | HIKMA CANADA LIMITED |
| Health Canada schedule | Ethical |
| ATC code | V03AB17 |
| ATC anatomical main group | V — Various |
| ATC therapeutic subgroup | V03AB |
| Current status | CANCELLED POST MARKET |
| Status date | 20-Jan-2026 |
| Original market date | 2016-02-19 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
Methemoglobinemia: 1-2 mg/kg IV over several minutes; may repeat after 1 hour. Diagnostic aid: 1-3 mL injected into opening.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Contraindicated in patients with severe renal impairment or a known hypersensitivity to the drug.
Warnings and precautions
Do not inject subcutaneously or intrathecally. Caution in G6PD deficiency (risk of hemolytic anemia). Monitor methemoglobin levels; high doses can cause methemoglobinemia.
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
2 of 11 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| METHYLENE BLUE INJECTION | 10 MG | SOLUTION | PHEBRA PTY LTD | MARKETED | 02487993 |
| METHYLENE BLUE INJECTION USP | 10 MG | LIQUID | OMEGA LABORATORIES LIMITED | MARKETED | 02230770 |
| METHYLENE BLEU LIQ 2% | 2 % | LIQUID | LABORATOIRE ATLAS INC | CANCELLED POST MARKET | 00050474 |
| METHYLENE BLUE INJ 1% | 10 MG | LIQUID | ALLEN & HANBURYS A GLAXO CANADA LTD. CO. | CANCELLED POST MARKET | 00465062 |
| METHYLENE BLUE INJ 1% USP | 1 % | LIQUID | DAVID BULL LABORATORIES (PTY) LTD. | CANCELLED POST MARKET | 00863610 |
| METHYLENE BLUE INJ 10MG/ML USP | 10 MG | LIQUID | GLAXO CANADA INC | CANCELLED POST MARKET | 01958674 |
| METHYLENE BLUE INJECTION USP | 10 MG | SOLUTION | ALVEDA PHARMACEUTICALS INC | CANCELLED (UNRETURNED ANNUAL) | 02302756 |
| METHYLENE BLUE INJECTION USP | 10 MG | SOLUTION | SANDOZ CANADA INCORPORATED | CANCELLED POST MARKET | 00816108 |
| METHYLENE BLUE INJECTION, USP | 1 % | LIQUID | HOSPIRA HEALTHCARE ULC | CANCELLED POST MARKET | 02137194 |
| METHYLENE BLUE INJECTION, USP | 10 MG | SOLUTION | MYLAN PHARMACEUTICALS ULC | CANCELLED PRE MARKET | 02094665 |
2 · Same class — other molecules in ATC V03AB
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Naloxone | INJECTABLE NALOXONE HYDROCHLORIDE · KLOXXADO · NALOXONE HCL INJECTION - 0.4MG/ML USP · NALOXONE HCL INJECTION - 1MG/ML USP · +11 more | 26 | 12 | Yes |
| Sugammadex | BRIDION · PMS-SUGAMMADEX · SUGAMMADEX · SUGAMMADEX INJECTION · +1 more | 14 | 4 | Yes |
| Thiosulphate | SEACALPHYX · SODIUM THIOSULFATE INJ 25% USP · SODIUM THIOSULFATE INJECTION USP | 4 | 3 | Yes |
| Methylthioninium Chloride | METHYLENE BLEU LIQ 2% · METHYLENE BLUE INJ 1% · METHYLENE BLUE INJ 1% USP · METHYLENE BLUE INJ 10MG/ML USP · +3 more | 11 | 2 | Yes |
| Flumazenil | ANEXATE INJ 0.1MG/ML · FLUMAZENIL INJECTION · FLUMAZENIL INJECTION SDZ · FLUMAZENIL INJECTION, USP · +1 more | 6 | 2 | Yes |
| Protamine | PROTAMINE SULFATE INJ 10MG/ML USP · PROTAMINE SULFATE INJECTION USP · PROTAMINE SULFATE INJECTION, USP | 4 | 2 | Yes |
| Fomepizole | ANTIZOL · FOMEPIZOLE FOR INJECTION | 2 | 2 | Yes |
| Hydroxocobalamin | CYANOKIT | 2 | 1 | Yes |
| Digitalis Antitoxin | DIGIBIND · DIGIFAB | 2 | 1 | Yes |
| Idarucizimab | PRAXBIND | 1 | 1 | Yes |
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 V03A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| V03AC | Deferasirox · Deferiprone · Deferoxamine | 57 | 44 |
| V03AN | Carbon Dioxide · Combination · Helium · Medical Air · Medical Gases · +2 more | 112 | 43 |
| V03AE | Calcium Acetate · Drugs For Treatment Of Hyperkalemia And Hyperphosphatemia · Lanthanum Carbonate · Patiromer Calcium · Polystyrene Sulphonate · +3 more | 40 | 19 |
| V03AF | Amifostine · Calcium Folinate · Dexrazoxane · Mesna · Palifermin · +1 more | 34 | 16 |
| V03AH | Diazoxide | 2 | 1 |
| V03AX | Cobicistat · Difelikefalin · Other Therapeutic Products | 8 | 1 |
| V03AZ | Ethanol | 1 | 0 |
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.
Can this still be bought in Canada?
No. This Drug Identification Number is cancelled post market in Health Canada's Drug Product Database, so the product is no longer authorized for sale in Canada and Nexara does not supply it. This page is kept as a regulatory record.
If you are looking for a current equivalent, the alternatives above list every product sharing this therapeutic class, with the marketed ones first. Ask us to source an alternative
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.