FLUOROURACIL INJECTION USP 50 MG — DIN 02413450
FLUOROURACIL : 50 MG · ACCORD HEALTHCARE INC · SOLUTION · wholesale supply in Canada
Health Canada status: MARKETED
What is FLUOROURACIL INJECTION USP?
FLUOROURACIL INJECTION USP 50 MG contains FLUOROURACIL : 50 MG. It is listed in the Health Canada Drug Product Database under DIN 02413450, held by ACCORD HEALTHCARE INC, supplied as SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 15-Jun-2017. 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 FLUOROURACIL INJECTION USP used for?
Palliative treatment of colorectal, breast, stomach, pancreas, prostate, ovary, bladder, and head and neck carcinomas; adjuvant therapy in colorectal and breast cancer.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How much does Fluorouracil cost around the world?
Fluorouracil is listed on 11 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; Bahrain publishes a retail (max); Greece publishes a 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 |
|---|---|---|---|---|
| Saudi Arabia | public | 11 | 15 | SAR███.██ |
| United States | acquisition | 4 | 10 | USD███.██ |
| Australia | ex-manufacturer | 6 | 9 | AUD███.██ |
| United Kingdom | hospital | 6 | 6 | GBP███.██ |
| Morocco | PPV (public price) | 5 | 5 | MAD███.██ |
| Romania | max producer price | 1 | 5 | RON███.██ |
| Norway | max AUP (pharmacy retail) | 2 | 4 | NOK███.██ |
| South Africa | single exit price | 3 | 4 | ZAR███.██ |
| United Arab Emirates | public | 3 | 3 | AED███.██ |
| Greece | producer price (ex-factory) | 3 | 3 | EUR███.██ |
| Bahrain | retail (max) | 1 | 1 | BHD███.██ |
65 pack listings across 45 brand entries and 10 price bases, refreshed 08 Sep 2026. Ranges span every Fluorouracil 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 Fluorouracil 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.
10 holders have a Canadian DIN containing Fluorouracil, across 15 DINs, of which 6 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 |
|---|---|---|---|---|
| BIOLYSE PHARMA CORPORATION | 2 | 2 | FLUOROURACIL INJECTION | Sourceable in Canada |
| ACCORD HEALTHCARE INC | 1 | 1 | FLUOROURACIL INJECTION USP | Sourceable in Canada |
| BAUSCH HEALTH, CANADA INC. | 1 | 1 | EFUDEX | Sourceable in Canada |
| HILL DERMACEUTICALS INC | 1 | 1 | TOLAK | Sourceable in Canada |
| SANDOZ CANADA INCORPORATED | 1 | 1 | FLUOROURACIL INJECTION | Sourceable in Canada |
| GENERIC MEDICAL PARTNERS INC | 4 | 0 | FLUOROURACIL INJECTION | No marketed DIN |
| PFIZER CANADA ULC | 2 | 0 | ADRUCIL, FLUOROURACIL INJECTION USP | No marketed DIN |
| ADRIA LABORATORIES OF CANADA LTD. | 1 | 0 | ADRUCIL INJ 50MG/ML | No marketed DIN |
| ALLERGAN HERBERT SKIN CARE DIVISION OF ALLERGAN INC. | 1 | 0 | FLUOROPLEX CREAM 1% | No marketed DIN |
| DAVID BULL LABORATORIES (PTY) LTD. | 1 | 0 | FLUOROURACIL INJ 50MG/ML | 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 MG |
|---|---|
| Dosage form | SOLUTION |
| Route | INTRAVENOUS |
| Pack configuration (monograph) | 5 g / 100 mL sterile, unpreserved solution in Pharmacy Bulk Vials (single packs). |
| Storage | Store at 15-30°C (implied by USP standard, though specific text omitted, dilution stable for 24h). Note: Pharmacy Bulk Vials should be used within 8 hours of entry. |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Fluorouracil |
|---|---|
| ATC code | L01BC02 |
| AHFS class | 10:00.00 |
| 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) | 02413450 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2413450 |
| Brand name | FLUOROURACIL INJECTION USP |
| Generic / active ingredient | FLUOROURACIL : 50 MG |
| Market authorization holder | ACCORD HEALTHCARE INC |
| Health Canada schedule | Prescription |
| ATC code | L01BC02 |
| ATC anatomical main group | L — Antineoplastic and immunomodulating agents |
| ATC therapeutic subgroup | L01BC |
| Current status | MARKETED |
| Status date | 15-Jun-2017 |
| Original market date | 2014-10-01 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
IV only. Initial: 12 mg/kg (500 mg/m2) daily for 5 days (good risk) or 6-10 mg/kg (poor risk). Max 800 mg/day. Maintenance: 10-15 mg/kg/week. Adjust for toxicity, renal, or hepatic impairment.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Pregnant women; poor nutritional state; severely depressed bone marrow function; serious infections; hypersensitivity; within 4 weeks of brivudine/sorivudine; complete DPD deficiency.
Warnings and precautions
Severe toxicity (stomatitis, diarrhea, neutropenia) due to DPD deficiency. Severe skin reactions (SJS/TEN). Myocardial ischemia. Neurologic toxicity. Myelosuppression.
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
6 of 15 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| EFUDEX | 5 % | CREAM | BAUSCH HEALTH, CANADA INC. | MARKETED | 00330582 |
| FLUOROURACIL INJECTION | 50 MG | SOLUTION | SANDOZ CANADA INCORPORATED | MARKETED | 00012882 |
| FLUOROURACIL INJECTION | 0.5 G / 10 ML | SOLUTION | BIOLYSE PHARMA CORPORATION | MARKETED | 02473763 |
| FLUOROURACIL INJECTION | 5 G / 100 ML | SOLUTION | BIOLYSE PHARMA CORPORATION | MARKETED | 02473771 |
| TOLAK | 4 % | CREAM | HILL DERMACEUTICALS INC | MARKETED | 02485346 |
| ADRUCIL | 50 MG | SOLUTION | PFIZER CANADA ULC | CANCELLED POST MARKET | 02063921 |
| ADRUCIL INJ 50MG/ML | 500 MG / 10 ML | LIQUID | ADRIA LABORATORIES OF CANADA LTD. | CANCELLED POST MARKET | 00428493 |
| FLUOROPLEX CREAM 1% | 1 % | CREAM | ALLERGAN HERBERT SKIN CARE DIVISION OF ALLERGAN INC. | CANCELLED POST MARKET | 01982311 |
| FLUOROURACIL INJ 50MG/ML | 50 MG | LIQUID | DAVID BULL LABORATORIES (PTY) LTD. | CANCELLED POST MARKET | 00891754 |
| FLUOROURACIL INJECTION | 250 MG / 5 ML | SOLUTION | GENERIC MEDICAL PARTNERS INC | APPROVED | 02476711 |
2 · Same class — other molecules in ATC L01BC
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Capecitabine | ACH-CAPECITABINE · APO-CAPECITABINE · CAPECITABINE · MINT-CAPECITABINE · SANDOZ CAPECITABINE · TARO-CAPECITABINE · TEVA-CAPECITABINE · XELODA | 20 | 11 | Yes |
| Azacitidine | AZACITIDINE FOR INJECTION · NAT-AZACITIDINE · ONUREG · PMS-AZACITIDINE FOR INJECTION · REDDY-AZACITIDINE · VIDAZA | 14 | 7 | Yes |
| Fluorouracil | ADRUCIL · ADRUCIL INJ 50MG/ML · EFUDEX · FLUOROPLEX CREAM 1% · FLUOROURACIL INJ 50MG/ML · FLUOROURACIL INJECTION · FLUOROURACIL INJECTION USP · TOLAK | 15 | 6 | Yes |
| Cytarabine | AJ-CYTARABINE · CYTARABINE - PWS 1GN/VIAL · CYTARABINE - PWS 2GM/VIAL · CYTARABINE - PWS 500MG/VIAL · CYTARABINE INJ 100MG/ML · CYTARABINE INJECTION · CYTARABINE INJECTION BP · CYTARABINE INJECTION, MYLAN STD. · CYTARABINE-PWS 100MG/VIAL · CYTOSAR · DEPOCYT · PMS-CYTARABINE | 19 | 3 | Yes |
| Gemcitabine | ACT GEMCITABINE · AJ-GEMCITABINE · GEMCITABINE FOR INJECTION · GEMCITABINE FOR INJECTION CONCENTRATE · GEMCITABINE FOR INJECTION USP · GEMCITABINE FOR INJECTION, USP · GEMCITABINE HYDROCHLORIDE FOR INJECTION · GEMCITABINE INJECTION · GEMCITABINE SUN FOR INJECTION · GEMZAR (1GM/VIAL) · GEMZAR (200MG/VIAL) | 38 | 2 | Yes |
| Trifluridine, Combinations | LONSURF | 2 | 2 | Yes |
| Decitabine | DACOGEN · DEMYLOCAN | 2 | 1 | Yes |
| Fluorouracil, Combinations | ACTIKERALL | 1 | 1 | Yes |
| Decitabine, Combinations | INQOVI | 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 L01B
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| L01BA | Methotrexate · Pemetrexed · Pralatrexate% · Raltitrexed | 90 | 36 |
| L01BB | Cladribine · Clofarabine · Fludarabine · Mercaptopurine · Nelarabine · Tioguanine | 18 | 10 |
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 FLUOROURACIL INJECTION USP called?
The same molecule, Fluorouracil, 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 |
|---|---|---|
| Fluorouracil Accord | Latin | Australia |
| Tolak | Latin | Norway |
| Efudix | Latin | Australia, South Africa |
| Actikerall | Latin | Norway |
| FLUORO URACILE ICN | Latin | Morocco |
| FLUOROURACIL EBEWE | Latin | Morocco |
| Fluorouracil Viatris | Latin | Australia |
| FLUOROURACILE MYLAN | Latin | Morocco |
| PHARMAURACIL | Latin | Morocco |
| Verrumal® | Latin | United Arab Emirates |
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.