INJECTABLE NALOXONE HYDROCHLORIDE 0.4 MG — DIN 02455935
NALOXONE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE DIHYDRATE) : 0.4 MG · OMEGA LABORATORIES LIMITED · SOLUTION · wholesale supply in Canada
Health Canada status: MARKETED
What is INJECTABLE NALOXONE HYDROCHLORIDE?
INJECTABLE NALOXONE HYDROCHLORIDE 0.4 MG contains NALOXONE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE DIHYDRATE) : 0.4 MG. It is listed in the Health Canada Drug Product Database under DIN 02455935, held by OMEGA LABORATORIES LIMITED, supplied as SOLUTION for SUBCUTANEOUS ; INTRAVENOUS ; INTRAMUSCULAR administration. Health Canada currently lists it as marketed, status dated 05-Aug-2016. 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 INJECTABLE NALOXONE HYDROCHLORIDE used for?
INJECTABLE NALOXONE HYDROCHLORIDE (naloxone hydrochloride) is a pure opioid antagonist indicated for emergency use to reverse known or suspected opioid overdoses, as manifested by respiratory depression and/or severe central nervous system depression. INJECTABLE NALOXONE HYDROCHLORIDE can be administered by a bystander (non- health care professional) before emergency medical assistance becomes available but it is not intended to be a substitute for professional medical care.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Naloxone cost around the world?
Naloxone is listed on 9 of the national price registers Nexara ingests. Each country publishes on a different basis, so those figures are not comparable with one another — or with a Canadian wholesale price.
What a market publishes matters more than the number it publishes. Australia publishes a ex-manufacturer; Austria publishes a KVP (Kassenverkaufspreis); Czechia publishes a max producer price (ex-factory). Comparing an ex-factory ceiling against a pharmacy public price tells you nothing about either, and comparing either against a Canadian landed cost tells you less.
| Market | Price basis published there | Brands | Packs listed | Range |
|---|---|---|---|---|
| United States | acquisition | 4 | 32 | USD███.██ |
| Australia | ex-manufacturer | 6 | 14 | AUD███.██ |
| Czechia | max producer price (ex-factory) | 2 | 3 | CZK███.██ |
| Greece | producer price (ex-factory) | 2 | 2 | EUR███.██ |
| Austria | KVP (Kassenverkaufspreis) | 1 | 1 | EUR███.██ |
| United Kingdom | hospital | 1 | 1 | GBP███.██ |
| Italy | ex-factory (classe H) | 1 | 1 | EUR███.██ |
| Luxembourg | reimbursement | 1 | 1 | EUR███.██ |
| South Africa | single exit price | 1 | 1 | ZAR███.██ |
56 pack listings across 19 brand entries and 9 price bases, refreshed 08 Sep 2026. Ranges span every Naloxone pack in that market, so a high figure is usually a larger pack rather than the same product.
Canada publishes no comparable public list price. For a delivered Canadian price on a licensed account, verify your licence — it takes about a minute.
Is there a generic Naloxone 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 Naloxone, across 26 DINs, of which 12 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 |
|---|---|---|---|---|
| SANDOZ CANADA INCORPORATED | 5 | 3 | NALOXONE HCL INJECTION - 0.4MG/ML USP, NALOXONE HCL INJECTION - 1MG/ML USP, NALOXONE HYDROCHLORIDE INJECTION SDZ PRESERVATIVE FREE, S.O.S. NALOXONE HYDROCHLORIDE INJECTION | Sourceable in Canada |
| OMEGA LABORATORIES LIMITED | 4 | 3 | INJECTABLE NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE INJECTION | Sourceable in Canada |
| HIKMA CANADA LIMITED | 3 | 2 | KLOXXADO, NALOXONE HYDROCHLORIDE INJECTION USP, NALOXONE INJECTABLE | Sourceable in Canada |
| EMERGENT OPERATIONS IRELAND LIMITED | 2 | 1 | NARCAN NASAL SPRAY | Sourceable in Canada |
| EUGIA PHARMA INC. | 2 | 1 | NALOXONE HYDROCHLORIDE INJECTION, USP | Sourceable in Canada |
| STERINOVA INC. | 1 | 1 | NALOXONE HYDROCHLORIDE INJECTION USP | Sourceable in Canada |
| TEVA CANADA LIMITED | 1 | 1 | TEVA-NALOXONE NASAL SPRAY | Sourceable in Canada |
| BRISTOL-MYERS SQUIBB CANADA | 3 | 0 | NARCAN INJECTION 0.02MG/ML, NARCAN INJECTION 0.4MG/ML, NARCAN INJECTION 1MG/ML | No marketed DIN |
| AURO PHARMA INC | 2 | 0 | NALOXONE HYDROCHLORIDE INJECTION, USP | No marketed DIN |
| BAXTER CORPORATION | 2 | 0 | NALOXONE HYDROCHLORIDE INJECTION, USP | No marketed DIN |
| STRIDES PHARMA CANADA INC | 1 | 0 | NALOXONE HYDROCHLORIDE 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 | 0.4 MG |
|---|---|
| Dosage form | SOLUTION |
| Route | SUBCUTANEOUS ; INTRAVENOUS ; INTRAMUSCULAR |
| Pack configuration (monograph) | 1 mL vials (0.4 mg / mL), boxes of 10 vials; 2 mL vials (1 mg / mL), boxes of 10 vials |
| Storage | INJECTABLE NALOXONE HYDROCHLORIDE should be stored between 15 and 30°C, protected from light. |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Naloxone |
|---|---|
| ATC code | V03AB15 |
| AHFS class | 28:16.08.04 |
| 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) | 02455935 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2455935 |
| Brand name | INJECTABLE NALOXONE HYDROCHLORIDE |
| Generic / active ingredient | NALOXONE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE DIHYDRATE) : 0.4 MG |
| Market authorization holder | OMEGA LABORATORIES LIMITED |
| Health Canada schedule | Ethical |
| ATC code | V03AB15 |
| ATC anatomical main group | V — Various |
| ATC therapeutic subgroup | V03AB |
| Current status | MARKETED |
| Status date | 05-Aug-2016 |
| Original market date | 2016-07-25 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
Is Naloxone in shortage in Canada?
A Canadian shortage report is on file for a product containing this molecule: Anticipated — reported by OMEGA LABORATORIES LIMITED, last seen 04 Sep 2026. A shortage on one presentation does not always affect every DIN of the molecule — the alternatives below list what else is marketed in Canada. Nexara can confirm current availability and identify substitutions or import options where permitted.
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
12 of 26 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| NALOXONE HCL INJECTION - 0.4MG/ML USP | 0.4 MG | LIQUID | SANDOZ CANADA INCORPORATED | MARKETED | 02148706 |
| NALOXONE HCL INJECTION - 1MG/ML USP | 1 MG | LIQUID | SANDOZ CANADA INCORPORATED | MARKETED | 02148714 |
| NALOXONE HYDROCHLORIDE INJECTION | 0.4 MG | SOLUTION | OMEGA LABORATORIES LIMITED | MARKETED | 02393034 |
| NALOXONE HYDROCHLORIDE INJECTION | 1 MG | SOLUTION | OMEGA LABORATORIES LIMITED | MARKETED | 02393042 |
| NALOXONE HYDROCHLORIDE INJECTION USP | 0.4 MG | SOLUTION | HIKMA CANADA LIMITED | MARKETED | 02382482 |
| NALOXONE HYDROCHLORIDE INJECTION USP | 0.4 MG | SOLUTION | STERINOVA INC. | MARKETED | 02548194 |
| NALOXONE HYDROCHLORIDE INJECTION, USP | 4 MG / 10 ML | SOLUTION | EUGIA PHARMA INC. | MARKETED | 02534975 |
| NALOXONE INJECTABLE | 0.4 MG | SOLUTION | HIKMA CANADA LIMITED | MARKETED | 02458578 |
| NARCAN NASAL SPRAY | 4 MG / 0.1 ML | SPRAY, METERED DOSE | EMERGENT OPERATIONS IRELAND LIMITED | MARKETED | 02458187 |
| S.O.S. NALOXONE HYDROCHLORIDE INJECTION | 0.4 MG | SOLUTION | SANDOZ CANADA INCORPORATED | MARKETED | 02453258 |
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.
What else is INJECTABLE NALOXONE HYDROCHLORIDE called?
The same molecule, Naloxone, is registered under other names elsewhere. Buyers and prescribers searching from outside Canada — or working from a foreign prescription or tender document — often know it by one of these:
| Name | Script | Registered in |
|---|---|---|
| Naloxone Hydrochloride (DBL) | Latin | Australia |
| Naloxone Juno | Latin | Australia |
| NALOXONE SXP | Latin | Australia |
| NALOXONE WZF POLFA | Latin | Czechia |
| Nyxoid | Latin | Australia |
| Prenoxad | Latin | Australia |
| NALOXONE POLPHARMA | Latin | Czechia |
| NARCAN | Latin | Australia |
Names are taken from national medicine registers and published price lists. A product registered abroad is not authorized for sale in Canada unless it holds its own DIN; import is possible only through the routes Health Canada permits.
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.