Prescription medicine
Ofloxacin Brand names: Ocuflox; first approved as Floxin
Ofloxacin (Ocuflox) is a prescription medicine with an FDA approval on record since 1990. FDA's NDC Directory lists it from 30 generic labelers, and pharmacies paid $1.24 per mL (Ofloxacin 0.3% eye drops) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the ofloxacin FDA label on DailyMed (effective July 18, 2024, Amneal Pharmaceuticals NY LLC); the NDA 19735 record on Drugs@FDA; every ofloxacin label on DailyMed.
Highlights of the record
FDA label of July 18, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageOfloxacin otic solution, 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: Otitis Externa in adults and pediatric patients, 6 months and older, due to Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aureus.
Forms and strengths
- 200 mg
- 300 mg
- 400 mg
- 3 mg/ml
Solution; solution/ drops; film-coated tablet.
On the market
- Earliest approval on file
- December 28, 1990 Floxin, Janssen Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 29 first January 16, 2002; 20 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 31 of which 30 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $1.24 per mL Ofloxacin 0.3% eye drops
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 5 since 2013 0 Class I among all firms' recalls; latest October 13, 2022
- FAERS reports
- 7,263 through July 30, 2026
What is ofloxacin used for?
From the label: indications and usageOfloxacin otic solution, 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: Otitis Externa in adults and pediatric patients, 6 months and older, due to Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aureus. Chronic Suppurative Otitis Media in patients 12 years and older with perforated tympanic membranes due to Proteus mirabilis, Pseudomonas aeruginosa, and Staphylococcus aureus. […]
Conditions named in the indications of ofloxacin's FDA labels, with every medicine labeled for each:
From other ofloxacin labelsBacterial infections: INDICATIONS AND USAGE Ofloxacin otic solution, 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below:
FDA pharmacologic class: Quinolone Antimicrobial.
Source: FDA drug label (Ofloxacin), Amneal Pharmaceuticals NY LLC, effective July 18, 2024 (SPL set ba37e2a0-1bf7-41ca-bddd-35fcb77f87de), via openFDA; the full label on DailyMed
Is there a generic for ofloxacin (Ocuflox)?
The FDA approved the first generic ofloxacin on January 16, 2002. 29 generic applications are approved; 20 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists ofloxacin from 30 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1990 earliest approval on file
- 2002 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for ofloxacin (Ocuflox)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.24 per mL (Ofloxacin 0.3% eye drops), down 23% from $1.61 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Ofloxacin 0.3% eye drops (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Ofloxacin 0.3% ear drops | Generic | $1.04 per mL | n/a | -15% |
| Ofloxacin 0.3% eye drops | Generic | $1.24 per mL | n/a | -23% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has ofloxacin been recalled?
The FDA's Enforcement Report lists 5 recalls naming ofloxacin since 2013: 0 Class I (the most serious), 3 Class II, 2 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| October 13, 2022 | Class II | Akorn, Inc. | CGMP Deviations: |
| April 13, 2022 | Class II | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse |
| July 2, 2019 | Class II | Altaire Pharmaceuticals, Inc. | Lack of Assurance of Sterility |
| September 9, 2013 | Class III | PACK Pharmaceuticals, LLC | Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the ofloxacin label say about other medicines?
The ofloxacin label names 4 other medicines in its interaction, contraindication or warning sections. The labels of 5 other medicines name ofloxacin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Caffeine | drug interactions | However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, and enhance the effects of the oral anticoagulant warfarin and its derivatives, and has been associated with transient elevations in serum creatinine in … |
| Cyclosporine | drug interactions | … its derivatives, and has been associated with transient elevations in serum creatinine in patients receiving cyclosporine concomitantly. |
| Theophylline | drug interactions | However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, and enhance the effects of the oral anticoagulant warfarin and its derivatives, and has been associated with transient elevations in serum creatinine in … |
| Warfarin | drug interactions | However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, and enhance the effects of the oral anticoagulant warfarin and its derivatives, and has been associated with transient elevations in serum creatinine in … |
Other labels that name ofloxacin
Source: FDA drug label (Ofloxacin), Amneal Pharmaceuticals NY LLC, effective July 18, 2024 (SPL set ba37e2a0-1bf7-41ca-bddd-35fcb77f87de), via openFDA; the full label on DailyMed
What do FAERS reports show for ofloxacin?
The FDA Adverse Event Reporting System holds 7,263 reports that list ofloxacin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 608 are coded as a death and 2,671 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ofloxacin?
9 other medicines are given the same way (ophthalmic) and in the same FDA class as ofloxacin or labeled mainly for the same use (bacterial infections), the same class first. Bacterial infections lists all 51 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (ophthalmic) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Ciprofloxacin | Bacterial infections | 12 labelers | $1.50 per mL 0.3% eye drop | No current entry |
| Tobramycin | Bacterial infections | 18 labelers | $1.11 per mL 0.3% eye drop | A presentation being discontinued |
| Dexamethasone and neomycin and polymyxin b | Bacterial infections | 9 labelers | $1.78 per mL Neomyc-polym-dexameth eye drop | No current entry |
| Gentamicin | Bacterial infections | 10 labelers | $0.790 per mL 0.3% eye drop | No current entry |
| Polymyxin b and trimethoprim | Bacterial infections | 10 labelers | $0.452 per mL Polymyxin b-tmp eye drops | No current entry |
| Sulfacetamide | Bacterial infections | 6 labelers | $1.96 per mL 10% eye drops | No current entry |
| Azithromycin | Bacterial infections | none listed | $98.51 per mL 1% eye drops | A presentation being discontinued |
| Bacitracin, hydrocortisone, neomycin and polymyxin b | Bacterial infections | 1 labeler | $5.52 per gram Neo-bacit-poly-hc eye ointment | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does ofloxacin compare with medicines for the same use?
6 side-by-side pages set ofloxacin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to ofloxacin
- 9 medicines for the same use
- Other quinolone antimicrobials
- the pharmacologic class, with prices and generics
- Ofloxacin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other