Active substance
Fluorouracil
- SFDA 15
- US FDA 55
- Health Canada 6
- US price lines 4
- NHS prices 2
- WHO EML 2
- Safety 5
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| FLORYL 50 MG/ML SOLUTION FOR INJECTION/INFUSION | 50 mg/ml | Solution for injection/infusion · Intravenous use | 1 Vial | SAR 98.50 | Generic · Prescription | Accord Healthcare Limited | Valid |
| FLORYL 50MG/ML SOL. FOR INJ./INFUSION | 50 mg/ml | Solution for injection/infusion · Intravenous use | 1 Vial | SAR 31.45 | Generic · Prescription | Accord Healthcare Limited | Valid |
| FLORYL 50MG/ML SOL. FOR INJ./INFUSION | 50 mg/ml | Solution for injection/infusion · Intravenous use | 1 Vial | SAR 29.85 | Generic · Prescription | Accord Healthcare Limited | Valid |
| Fluorouracil Ebewe 1000mg/20ml | 50 mg/ml | Solution for injection · Intravenous use | 1 Vial | SAR 38.45 | Generic · Prescription | EBEWE PHARMA | Valid |
| Fluorouracil Ebewe 5000mg/100ml | 50 mg/ml | Solution for injection · Intravenous use | 1 Vial | SAR 123.15 | Generic · Prescription | EBEWE PHARMA | Valid |
| Fluorouracil Ebewe 500mg/10ml | 50 mg/ml | Solution for injection · Parenteral use | 1 Vial | SAR 39.35 | Generic · Prescription | EBEWE PHARMA | Valid |
| EFUDIX 5% OINTMENT | 5 % | Ointment · Topical | 1 Tube | SAR 15.75 | Generic · Prescription | VALEANT PHARMACEUTICALS | Withdrawn by MAH · Not Marketed |
| FLORYL 50MG/ML SOL. FOR INJ./INFUSION | 50 mg/ml | Solution for injection/infusion · Intravenous use | 1 Vial | SAR 7.85 | Generic · Prescription | Accord Healthcare Limited | Withdrawn by MAH · Not Marketed |
| FLUORO-URACIL ICN 250MG-5ML VIAL | 50 mg/ml | Injection · Parenteral use | 5 Vial | SAR 29.25 | Generic · Prescription | VALEANT PHARMACEUTICALS | Withdrawn by MAH · Not Marketed |
| FLUOROURACIL 250MG-10ML VIAL | 25 mg/ml | Solution for injection · Parenteral use | 5 Vial | SAR 40.30 | NCE · Prescription | HOSPIRA UK LIMITED | Withdrawn by MAH · Not Marketed |
| FLUOROURACIL 250MG-10ML VIAL | 25 mg/ml | Solution for injection · Parenteral use | 5 Vial | SAR 40.30 | NCE · Prescription | HOSPIRA AUSTRALIA | Withdrawn by MAH · Not Marketed |
| FLUOROURACIL 500MG-10ML VIAL | 50 mg/ml | Solution for injection · Parenteral use | 5 Vial | SAR 63.45 | NCE · Prescription | HOSPIRA AUSTRALIA | Invalid · Not Marketed |
| FLUOROURACIL EBEWE AMP 50MG-ML | 50 mg/ml | concentrate for solution for injection · Intravenous use | 5 Ampoule | SAR 52.55 | Generic · Prescription | EBEWE PHARMA | Withdrawn by MAH · Not Marketed |
| FLUOROURACIL EBEWE AMP 50MG-ML | 50 mg/ml | concentrate for solution for injection · Intravenous use | 5 Ampoule | SAR 35.35 | Generic · Prescription | EBEWE PHARMA | Withdrawn by MAH · Not Marketed |
| FLUOROURACIL EBEWE VIAL 50MG-ML | 50 mg/ml | Solution for injection · Intravenous use | 1 Vial | SAR 10.35 | Generic · Prescription | EBEWE PHARMA | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
ANAL CANCER; BILIARY TRACT CANCER; BLADDER CANCER; BREAST CANCER EARLY HER-2 -VE; BREAST CANCER MET.HER-2 -VE; Cervical Cancer; COLORECTAL CANCER-EARLY & ADVANCED; ESOPHAGEAL CANCER; GASTRIC CANCER; HEAD AND NECK CANCER; MALIGNANT NEOPLASM OF THE PANCREAS; NEUROENDOCRINE TUMORS; OPEN ANGLE GLUCOMA; OVARIAN CANCER; PARATHYROID CANCER; THYROID CANCER-MEDULLARY CARCINOMA; VAGINAL AND VULVAR CANCERS
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| EFUDEX | 2% | solution · topical | EXTROVIS | Prescription | 29 Jul 1970 |
| EFUDEX | 5% | cream · topical | EXTROVIS | Prescription | 29 Jul 1970 |
| FLUOROURACIL | 2.5GM/50ML (50MG/ML); 5GM/100ML (50MG/ML) | injectable · injection | FRESENIUS KABI USA | Prescription | 30 Sep 1998 |
| FLUOROURACIL | 1GM/20ML (50MG/ML); 500MG/10ML (50MG/ML) | injectable · injection | FRESENIUS KABI USA | Prescription | 30 Sep 1998 |
| CARAC | 0.5% | cream · topical | EXTROVIS | Prescription | 27 Oct 2000 |
| FLUOROURACIL | 2%; 5% | solution · topical | TARO | Prescription | 5 Nov 2003 |
| FLUOROURACIL | 1GM/20ML (50MG/ML); 500MG/10ML (50MG/ML) | injectable · injection | ACCORD HLTHCARE | Prescription | 26 Apr 2007 |
| FLUOROURACIL | 5GM/100ML (50MG/ML) | injectable · injection | ACCORD HLTHCARE | Prescription | 26 Apr 2007 |
| FLUOROURACIL | 5% | cream · topical | DR REDDYS LABS SA | Prescription | 11 Apr 2008 |
| FLUOROURACIL | 5% | cream · topical | TARO | Prescription | 5 Mar 2010 |
| FLUOROURACIL | 500MG/10ML (50MG/ML); 1GM/20ML (50MG/ML) | injectable · injection | EUGIA PHARMA SPECLTS | Prescription | 17 Jul 2012 |
| FLUOROURACIL | 2.5GM/50ML (50MG/ML); 5GM/100ML (50MG/ML) | injectable · injection | EUGIA PHARMA SPECLTS | Prescription | 17 Jul 2012 |
| TOLAK | 4% | cream · topical | HILL DERMACEUTICALS | Prescription | 18 Sep 2015 |
| FLUOROURACIL | 2.5GM/50ML (50MG/ML); 5GM/100ML (50MG/ML) | injectable · injection | SAGENT PHARMS INC | Prescription | 17 Feb 2016 |
| FLUOROURACIL | 500MG/10ML (50MG/ML); 1GM/20ML (50MG/ML) | injectable · injection | SAGENT PHARMS INC | Prescription | 11 May 2017 |
| FLUOROURACIL | 500MG/10ML (50MG/ML); 1GM/20ML (50MG/ML) | injectable · injection | GLAND | Prescription | 27 Oct 2017 |
| FLUOROURACIL | 2.5GM/50ML (50MG/ML); 5GM/100ML (50MG/ML) | injectable · injection | GLAND | Prescription | 26 Dec 2017 |
| FLUOROURACIL | 5% | cream · topical | ACCORD HLTHCARE | Prescription | 7 Oct 2021 |
| FLUOROURACIL | 2.5GM/50ML (50MG/ML) | injectable · injection | ALEMBIC | Prescription | 3 Mar 2023 |
| FLUOROURACIL | 5GM/100ML (50MG/ML) | injectable · injection | ALEMBIC | Prescription | 18 Oct 2023 |
| FLUOROURACIL | 5% | solution · topical | ENCUBE | Prescription | 2 Nov 2023 |
| FLUOROURACIL | 2.5GM/50ML (50MG/ML) | injectable · injection | KINDOS | Prescription | 24 Sep 2024 |
| FLUOROURACIL | 5GM/100ML (50MG/ML) | injectable · injection | KINDOS | Prescription | 6 Feb 2025 |
| FLUOROURACIL | 5% | cream · topical | ENCUBE | Prescription | 12 Feb 2025 |
| FAVLYXA | 250MG/10ML (25MG/ML); 2.5GM/100ML (25MG/ML) | solution · intravenous | AVYXA HOLDINGS | Prescription | 20 Feb 2026 |
30 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| EFUDEX | 00330582 | 5 % / W/W | CREAM · TOPICAL | BAUSCH HEALTH, CANADA INC. |
| FLUOROURACIL INJECTION | 00012882 | 50 MG / ML | SOLUTION · INTRAVENOUS | SANDOZ CANADA INCORPORATED |
| FLUOROURACIL INJECTION | 02473763 | 0.5 G / 10 ML | SOLUTION · INTRAVENOUS | BIOLYSE PHARMA CORPORATION |
| FLUOROURACIL INJECTION | 02473771 | 5 G / 100 ML | SOLUTION · INTRAVENOUS | BIOLYSE PHARMA CORPORATION |
| FLUOROURACIL INJECTION USP | 02413450 | 50 MG / ML | SOLUTION · INTRAVENOUS | ACCORD HEALTHCARE INC |
| TOLAK | 02485346 | 4 % / W/W | CREAM · TOPICAL | HILL DERMACEUTICALS INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | FLUOROURACIL 0.5% CREAM | $42.87573 | per GM | 23 Sep 2026 |
| US NADAC | FLUOROURACIL 2% TOPICAL SOLN | $3.42131 | per ML | 23 Sep 2026 |
| US NADAC | FLUOROURACIL 5% CREAM | $0.61563 | per GM | 23 Sep 2026 |
| US NADAC | FLUOROURACIL 5% TOPICAL SOLN | $4.17343 | per ML | 23 Sep 2026 |
| NHS Drug Tariff | Fluorouracil 4% cream | £28.00 | 20 gram | 1 Oct 2026 |
| NHS Drug Tariff | Fluorouracil 5% cream | £32.90 | 40 gram | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
WHO WHO Model List of Essential Medicines (2025)
- 13.4. Dermatological medicines > Medicines affecting skin differentiation and proliferation · core
Plantar warts
Local > Topical > Ointment: 5% - 8.2.1. Cytotoxic medicines · complementary
Malignant neoplasms of nasopharynx; Malignant neoplasms of rectum; Malignant neoplasm metastasis in large intestine; Malignant neoplasms of breast; Malignant neoplasms of colon
Parenteral > General injections > IV: 50 mg per mL in vial
Safety signals and safety-related labeling changes
- US FDA 25 Aug 2022 TOLAK — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 26 May 2022 CARAC — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 28 Feb 2022 FLUOROPLEX — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 14 Oct 2021 EFUDEX — safety-related labeling change
Labeling sections changed: Warnings and Precautions - US FDA 29 Jul 2016 FLUOROURACIL — safety-related labeling change
Labeling sections changed: Warnings and Precautions
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.