NALOXONE HYDROCHLORIDE INJECTION USP 0.4 MG
NALOXONE HYDROCHLORIDE : 0.4 MG · DIN 02548194 · STERINOVA INC.
Health Canada status: MARKETED
What is NALOXONE HYDROCHLORIDE INJECTION USP?
NALOXONE HYDROCHLORIDE INJECTION USP 0.4 MG contains NALOXONE HYDROCHLORIDE : 0.4 MG. It is listed in the Health Canada Drug Product Database under DIN 02548194, held by STERINOVA INC., supplied as SOLUTION for SUBCUTANEOUS ; INTRAMUSCULAR administration. Health Canada currently lists it as marketed, status dated 26-Sep-2024. 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 NALOXONE HYDROCHLORIDE INJECTION USP used for?
Emergency use to reverse known or suspected opioid overdoses, manifested by respiratory depression and/or severe central nervous system depression.
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 | 02548194 |
|---|---|
| Brand name | NALOXONE HYDROCHLORIDE INJECTION USP |
| Generic / active ingredient | NALOXONE HYDROCHLORIDE : 0.4 MG |
| Manufacturer | STERINOVA INC. |
| Strength | 0.4 MG |
| Dosage form | SOLUTION |
| Route of administration | SUBCUTANEOUS ; INTRAMUSCULAR |
| Schedule | Ethical |
| ATC code | V03AB15 NALOXONE |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 26-Sep-2024 |
How is it administered?
Adults/Children >1yr: 0.4-2 mg initially. Children 0-1yr: 0.4 mg. Administer IM or SC. Repeat every 2-3 minutes if needed until emergency medical assistance arrives.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
Store between 20 and 25°C. Protect from freezing and from light.
How is it supplied?
1 mL single-use prefilled syringes (0.4 mg/mL) with a stacked needle (22G ½”) in a needle safety device, available in boxes of 10 units.
Contraindications
Hypersensitivity to naloxone hydrochloride or to any ingredient in the formulation or component of the container.
Warnings and precautions
Call 911 immediately. Risk of rebound opioid toxicity. May precipitate acute opioid withdrawal syndrome. Not effective against non-opioid overdoses. Use caution in patients with cardiac disease.
Is NALOXONE in shortage in Canada?
A Canadian shortage report is on file for 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?
Other Canadian products sharing ATC code V03AB15 NALOXONE. 12 of 26 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 |
|---|---|---|---|---|---|
| INJECTABLE NALOXONE HYDROCHLORIDE | 0.4 MG | SOLUTION | OMEGA LABORATORIES LIMITED | MARKETED | DIN 02455935 |
| NALOXONE HCL INJECTION - 0.4MG/ML USP | 0.4 MG | LIQUID | SANDOZ CANADA INCORPORATED | MARKETED | DIN 02148706 |
| NALOXONE HCL INJECTION - 1MG/ML USP | 1 MG | LIQUID | SANDOZ CANADA INCORPORATED | MARKETED | DIN 02148714 |
| NALOXONE HYDROCHLORIDE INJECTION | 0.4 MG | SOLUTION | OMEGA LABORATORIES LIMITED | MARKETED | DIN 02393034 |
| NALOXONE HYDROCHLORIDE INJECTION | 1 MG | SOLUTION | OMEGA LABORATORIES LIMITED | MARKETED | DIN 02393042 |
| NALOXONE HYDROCHLORIDE INJECTION USP | 0.4 MG | SOLUTION | HIKMA CANADA LIMITED | MARKETED | DIN 02382482 |
| NALOXONE HYDROCHLORIDE INJECTION, USP | 4 MG / 10 ML | SOLUTION | EUGIA PHARMA INC. | MARKETED | DIN 02534975 |
| NALOXONE INJECTABLE | 0.4 MG | SOLUTION | HIKMA CANADA LIMITED | MARKETED | DIN 02458578 |
| NARCAN NASAL SPRAY | 4 MG / 0.1 ML | SPRAY, METERED DOSE | EMERGENT OPERATIONS IRELAND LIMITED | MARKETED | DIN 02458187 |
| S.O.S. NALOXONE HYDROCHLORIDE INJECTION | 0.4 MG | SOLUTION | SANDOZ CANADA INCORPORATED | MARKETED | DIN 02453258 |
Who else supplies NALOXONE worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. NALOXONE appears in 47 registered pack listings across 9 markets, published on 9 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.