FENTANYL CITRATE INJECTION USP 50 MCG — DIN 02385406
FENTANYL (FENTANYL CITRATE) : 50 MCG · HIKMA CANADA LIMITED · SOLUTION · wholesale supply in Canada
Health Canada status: DORMANT
What is FENTANYL CITRATE INJECTION USP?
FENTANYL CITRATE INJECTION USP 50 MCG contains FENTANYL (FENTANYL CITRATE) : 50 MCG. It is listed in the Health Canada Drug Product Database under DIN 02385406, held by HIKMA CANADA LIMITED, supplied as SOLUTION for EPIDURAL ; INTRAVENOUS ; INTRAMUSCULAR administration. Health Canada currently lists it as dormant, status dated 05-Oct-2024. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A). This DIN is not currently being marketed in Canada, so it is sourced to order where a compliant route exists rather than held in stock.
What is FENTANYL CITRATE INJECTION USP used for?
Analgesic for short duration during anesthesia (premedication, induction, maintenance) and postoperative period; supplement in general/regional anesthesia; anesthetic agent in high-risk surgery.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Fentanyl cost around the world?
Fentanyl is listed on 17 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); Bahrain publishes a retail (max). 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 |
|---|---|---|---|---|
| Czechia | max producer price (ex-factory) | 17 | 104 | CZK███.██ |
| Sweden | AIP (pharmacy purchase price) | 10 | 95 | SEK███.██ |
| Austria | KVP (Kassenverkaufspreis) | 38 | 58 | EUR███.██ |
| United States | acquisition | 10 | 56 | USD███.██ |
| Australia | ex-manufacturer | 5 | 45 | AUD███.██ |
| Romania | max producer price | 26 | 45 | RON███.██ |
| Norway | max AUP (pharmacy retail) | 3 | 43 | NOK███.██ |
| Greece | producer price (ex-factory) | 41 | 41 | EUR███.██ |
| Hungary | producer price (ex-factory) | 23 | 30 | HUF███.██ |
| Saudi Arabia | public | 20 | 29 | SAR███.██ |
| Luxembourg | reimbursement | 20 | 20 | EUR███.██ |
| Slovakia | categorised final price | 18 | 18 | EUR███.██ |
| South Africa | single exit price | 17 | 17 | ZAR███.██ |
| Morocco | PPV (public price) | 5 | 9 | MAD███.██ |
| Bahrain | retail (max) | 3 | 8 | BHD███.██ |
| United Arab Emirates | public | 4 | 4 | AED███.██ |
| United Kingdom | hospital | 3 | 3 | GBP███.██ |
625 pack listings across 263 brand entries and 15 price bases, refreshed 08 Sep 2026. Ranges span every Fentanyl 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 Fentanyl 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.
9 holders have a Canadian DIN containing Fentanyl, across 13 DINs, of which 8 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 |
|---|---|---|---|---|
| STERIMAX INC | 4 | 4 | FENTANYL INJECTION BP | Sourceable in Canada |
| SANDOZ CANADA INCORPORATED | 2 | 2 | FENTANYL CITRATE INJECTION SDZ, FENTANYL CITRATE INJECTION USP | Sourceable in Canada |
| FRESENIUS KABI CANADA LTD | 1 | 1 | FENTANYL CITRATE INJECTION, USP | Sourceable in Canada |
| JAMP PHARMA CORPORATION | 1 | 1 | FENTANYL CITRATE INJECTION | Sourceable in Canada |
| DAVID BULL LABORATORIES (CANADA) INC. | 1 | 0 | FENTANYL CITRATE INJECTION USP 50MCG/ML | No marketed DIN |
| HIKMA CANADA LIMITED | 1 | 0 | FENTANYL CITRATE INJECTION USP | No marketed DIN |
| HOSPIRA HEALTHCARE ULC | 1 | 0 | FENTANYL CITRATE INJECTION U.S.P.-LIQ IV IM EPD | No marketed DIN |
| JANSSEN PHARMACEUTICA, DIVISION OF JANSSEN-ORTHO INC. | 1 | 0 | SUBLIMAZE INJ 50MCG/ML | No marketed DIN |
| PFIZER CANADA ULC | 1 | 0 | FENTANYL CITRATE 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 | 50 MCG |
|---|---|
| Dosage form | SOLUTION |
| Route | EPIDURAL ; INTRAVENOUS ; INTRAMUSCULAR |
| Pack configuration (monograph) | Not explicitly detailed in provided text (refers to DOSAGE FORMS, COMPOSITION, AND PACKAGING section). |
| Storage | Not explicitly detailed in provided text (refers to STORAGE AND STABILITY section). |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Fentanyl |
|---|---|
| ATC code | N01AH01 |
| AHFS class | 28:08.08 |
| 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) | 02385406 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2385406 |
| Brand name | FENTANYL CITRATE INJECTION USP |
| Generic / active ingredient | FENTANYL (FENTANYL CITRATE) : 50 MCG |
| Market authorization holder | HIKMA CANADA LIMITED |
| Health Canada schedule | NARCOTICS (CDSA I) |
| ATC code | N01AH01 |
| ATC anatomical main group | N — Nervous system |
| ATC therapeutic subgroup | N01AH |
| Current status | DORMANT |
| Status date | 05-Oct-2024 |
| Original market date | 2016-04-18 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
IV, IM, or epidural. Dosage must be individualized. IV/IM for anesthesia adjunct/analgesia; epidural for postoperative pain. Slow IV injection recommended to reduce muscle rigidity.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Hypersensitivity to fentanyl/opioids; GI obstruction; acute abdominal conditions; mild pain; asthma/COPD; respiratory depression; alcoholism; increased intracranial pressure; MAO inhibitors use.
Warnings and precautions
Serious risk of addiction, abuse, misuse, and fatal respiratory depression. Concomitant use with benzodiazepines or alcohol may result in coma or death. May cause muscle rigidity.
Is Fentanyl in shortage in Canada?
A Canadian shortage report is on file for a product containing this molecule: Resolved — reported by FRESENIUS KABI CANADA LTD, last seen 09 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
8 of 13 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| FENTANYL CITRATE INJECTION | 50 MCG | SOLUTION | JAMP PHARMA CORPORATION | MARKETED | 02506963 |
| FENTANYL CITRATE INJECTION SDZ | 50 MCG | SOLUTION | SANDOZ CANADA INCORPORATED | MARKETED | 02384124 |
| FENTANYL CITRATE INJECTION USP | 50 MCG | SOLUTION | SANDOZ CANADA INCORPORATED | MARKETED | 02240434 |
| FENTANYL CITRATE INJECTION, USP | 50 MCG | SOLUTION | FRESENIUS KABI CANADA LTD | MARKETED | 02501554 |
| FENTANYL INJECTION BP | 100 MCG / 2 ML | SOLUTION | STERIMAX INC | MARKETED | 02496143 |
| FENTANYL INJECTION BP | 250 MCG / 5 ML | SOLUTION | STERIMAX INC | MARKETED | 02496151 |
| FENTANYL INJECTION BP | 1000 MCG / 20 ML | SOLUTION | STERIMAX INC | MARKETED | 02496178 |
| FENTANYL INJECTION BP | 2500 MCG / 50 ML | SOLUTION | STERIMAX INC | MARKETED | 02496186 |
| FENTANYL CITRATE INJECTION U.S.P.-LIQ IV IM EPD | 50 MCG | SOLUTION | HOSPIRA HEALTHCARE ULC | CANCELLED POST MARKET | 02126648 |
| FENTANYL CITRATE INJECTION USP | 50 MCG | SOLUTION | PFIZER CANADA ULC | CANCELLED POST MARKET | 00888346 |
2 · Same class — other molecules in ATC N01AH
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Fentanyl | FENTANYL CITRATE INJECTION · FENTANYL CITRATE INJECTION SDZ · FENTANYL CITRATE INJECTION U.S.P.-LIQ IV IM EPD · FENTANYL CITRATE INJECTION USP · +4 more | 13 | 8 | Yes |
| Remifentanil | REMIFENTANIL FOR INJECTION · REMIFENTANIL HYDROCHLORIDE FOR INJECTION · ULTIVA | 10 | 2 | Yes |
| Sufentanil | SUFENTA INJ 50MCG/ML · SUFENTANIL CITRATE INJECTION · SUFENTANIL CITRATE INJECTION USP | 5 | 2 | Yes |
| Alfentanil | ALFENTA INJ 500MCG/ML · ALFENTANIL INJECTION USP | 2 | 0 | Not in Canada |
| Anileridine | LERITINE INJ 25MG/ML · LERITINE TABLETS 25MG | 2 | 0 | Not in Canada |
| Fentanyl, Combinations | INNOVAR INJ | 1 | 0 | Not in Canada |
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 N01A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| N01AX | Droperidol · Etomidate · Ketamine · Nitrous Oxide · Nitrous Oxide,Combinations · +1 more | 38 | 19 |
| N01AB | Desflurane · Enflurane · Halothane · Isoflurane · Sevoflurane | 19 | 6 |
| N01AF | Methohexital · Thiopental | 6 | 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 FENTANYL CITRATE INJECTION USP called?
The same molecule, Fentanyl, 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 |
|---|---|---|
| Fentanyl ratiopharm | Latin | Norway, Sweden |
| Fentanyl Sandoz | Latin | Australia, Norway, Sweden |
| Matrifen | Latin | Czechia, Sweden |
| Durogesic | Latin | Bahrain, Czechia, Morocco, Norway |
| Abstral | Latin | Australia, Sweden |
| Fentanyl Lavipharm | Latin | Sweden |
| Fentanyl Orion | Latin | Sweden |
| LUNALDIN | Latin | Czechia |
| APO-Fentanyl | Latin | Australia |
| Durogesic® | Latin | Sweden |
| FENTANYL VIATRIS | Latin | Czechia |
| DOLFORIN | Latin | Czechia |
| Submena | Latin | Sweden |
| FENTANYL MYLAN | Latin | Czechia, Morocco |
| Fentora | 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?
This DIN is dormant — it holds a Health Canada authorization but is not currently being marketed in Canada, so it cannot simply be ordered from Canadian stock. Where a patient need exists, supply may be possible through exceptional importation or the Special Access Programme, subject to Health Canada's requirements and the prescriber's application. Nexara can advise on the route and on marketed alternatives.
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.