Active substance
Ofloxacin
- SFDA 9
- US FDA 37
- Health Canada 1
- US price lines 4
- NHS prices 3
- WHO EML 2
- Safety 5
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| EYLOX 0.3% EYE DROPS | 0.3 % | Eye drops · Ophthalmic use | 1 Dropper Container | SAR 13.15 | Generic · Prescription | Amman Pharmaceutical Industries (API) | Valid |
| OCUFLOXIN 3 mg/ml ophthamic solution | 3 mg/ml | Eye drops, solution · Ophthalmic use | 20 Ampoule | SAR 20.00 | Generic · Prescription | Pharmaceutical Solution Industries (PSI) | Valid |
| OFLACIN 200MG TAB | 200 mg | Tablet · Oral use | 10 Blister | SAR 27.90 | Generic · Prescription | Ram Pharmaceutical Industries | Valid |
| OFLOX 0.3% EYE DROPS | 0.3 % | Eye drops, solution · Ophthalmic use | 1 Dropper Container | SAR 13.50 | NCE · Prescription | ABBVIE LIMITED | Valid |
| OPTIFLOX OPTHALMIC SOLUTION | 0.3 % | Eye drops, solution · Ophthalmic use | 1 Dropper Container | SAR 12.80 | Generic · Prescription | Jamjoom Pharmaceuticals Factory Company | Valid |
| JEDCOFLACIN 200MG TABLETS | 200 mg | Tablet · Oral use | 10 Blister | SAR 23.70 | Generic · Prescription | JEDCO INTERNATIONAL PHARMACEUTICAL | Suspended |
| OXACIN | 0.3 % | Eye drops, solution · Ophthalmic use | 1 Dropper Container | SAR 7.45 | Generic · Prescription | RIYADH PHARMA | Withdrawn by MAH · Not Marketed |
| TARIVID 200MG F-C TAB | 200 mg | Film-coated tablet · Oral use | 10 Blister | SAR 38.30 | NCE · Prescription | sanofi-aventis | Withdrawn by MAH · Not Marketed |
| TARIVID I.V2MG-MLSOLUTION FOR INFUSION | 2 mg | Solution · Intravenous use | 5 Vial | SAR 409.80 | Generic · Prescription | sanofi-aventis | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
MUCOPURULENT CONJUCTIVITIS - CHLAMYDIAL CONJUNCTIVITIS; OTITIS EXTERNA
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| OCUFLOX | 0.3% | solution/drops · ophthalmic | ALLERGAN | Prescription | 30 Jul 1993 |
| OFLOXACIN | 400MG | tablet · oral | CHARTWELL RX | Prescription | 2 Sep 2003 |
| OFLOXACIN | 200MG; 300MG; 400MG | tablet · oral | TEVA | Prescription | 2 Sep 2003 |
| OFLOXACIN | 0.3% | solution/drops · ophthalmic | APOTEX INC | Prescription | 14 May 2004 |
| OFLOXACIN | 0.3% | solution/drops · ophthalmic | BAUSCH AND LOMB | Prescription | 14 May 2004 |
| OFLOXACIN | 200MG; 300MG; 400MG | tablet · oral | DR REDDYS LABS LTD | Prescription | 10 Feb 2006 |
| OFLOXACIN | 0.3% | solution/drops · otic | APOTEX INC | Prescription | 28 Sep 2007 |
| OFLOXACIN | 0.3% | solution/drops · otic | BAUSCH AND LOMB INC | Prescription | 17 Mar 2008 |
| OFLOXACIN | 0.3% | solution/drops · ophthalmic | SENTISS | Prescription | 15 Apr 2008 |
| OFLOXACIN | 0.3% | solution/drops · ophthalmic | FDC LTD | Prescription | 25 Feb 2009 |
| OFLOXACIN | 0.3% | solution/drops · ophthalmic | ALTAIRE PHARMS INC | Prescription | 29 Apr 2013 |
| OFLOXACIN | 200MG; 300MG; 400MG | tablet · oral | CADILA PHARMS LTD | Prescription | 18 Sep 2014 |
| OFLOXACIN | 0.3% | solution/drops · otic | AMNEAL | Prescription | 30 Aug 2019 |
| OFLOXACIN | 0.3% | solution/drops · otic | FDC LTD | Prescription | 19 Jan 2022 |
| OFLOXACIN | 0.3% | solution/drops · otic | MANKIND PHARMA | Prescription | 14 Jul 2022 |
| OFLOXACIN | 0.3% | solution/drops · ophthalmic | MANKIND PHARMA | Prescription | 23 Nov 2022 |
| OFLOXACIN | 0.3% | solution/drops · otic | CAPLIN | Prescription | 5 Jan 2024 |
| OFLOXACIN | 0.3% | solution/drops · ophthalmic | CAPLIN | Prescription | 12 Apr 2024 |
| OFLOXACIN | 0.3% | solution/drops · ophthalmic | SOMERSET | Prescription | 1 Aug 2024 |
| OFLOXACIN | 0.3% | solution/drops · otic | SOMERSET THERAPS LLC | Prescription | 15 Oct 2024 |
| OFLOXACIN | 0.3% | solution/drops · ophthalmic | MICRO LABS | Prescription | 8 Apr 2026 |
| FLOXIN | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | JANSSEN PHARMS | Discontinued | 28 Dec 1990 |
| FLOXIN IN DEXTROSE 5% | 400MG/100ML | injectable · injection | ORTHO MCNEIL PHARM | Discontinued | 31 Mar 1992 |
| FLOXIN | 20MG/ML; 40MG/ML | injectable · injection | ORTHO MCNEIL PHARM | Discontinued | 31 Mar 1992 |
| FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 4MG/ML; 400MG/100ML | injectable · injection | ORTHO MCNEIL PHARM | Discontinued | 31 Mar 1992 |
12 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| OCUFLOX | 02143291 | 0.3 % / W/V | SOLUTION · OPHTHALMIC | ABBVIE CORPORATION |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | OFLOXACIN 0.3% EAR DROPS | $1.10981 | per ML | 23 Sep 2026 |
| US NADAC | OFLOXACIN 0.3% EAR DROPS | $0.97895 | per ML | 23 Sep 2026 |
| US NADAC | OFLOXACIN 0.3% EYE DROPS | $1.24141 | per ML | 23 Sep 2026 |
| US NADAC | OFLOXACIN 0.3% EYE DROPS | $1.11355 | per ML | 23 Sep 2026 |
| NHS Drug Tariff | Ofloxacin 0.3% eye drops | £2.17 | 5 ml | 1 Oct 2026 |
| NHS Drug Tariff | Ofloxacin 200mg tablets | £9.37 | 10 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Ofloxacin 400mg tablets | £11.30 | 5 tablet | 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)
- 28. Ear, nose and throat medicines [c] · core
Therapeutic equivalent to ciprofloxacin for Infectious diseases of external ear - 21.1. Ophthalmological preparations > Anti-infective agents · core
Other specified conjunctivitis; Infectious keratitis
Local > Ophthalmological > Solution (eye drops): 0.3%
Safety signals and safety-related labeling changes
- EMA PRAC 2 Sep 2021 PRAC signal: Acquired thrombotic thrombocytopenia purpura
Action for MAH: update of the product information: No - EMA PRAC 9 Apr 2021 PRAC signal: Acquired thrombotic thrombocytopenia purpura
Action for MAH: update of the product information: No - EMA PRAC 3 Sep 2020 PRAC signal: Heart valve regurgitation, cervical artery dissection, and aortic aneurysm and dissection
Action for MAH: update of the product information: Yes - EMA PRAC 14 May 2020 PRAC signal: Heart valve regurgitation, cervical artery dissection, and aortic aneurysm and dissection
Action for MAH: update of the product information: No - EMA PRAC 16 Jan 2020 PRAC signal: Heart valve regurgitation
Action for MAH: update of the product information: No
Combinations containing Ofloxacin
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.