Ofloxacin ophthalmic 3 mg/mL Solution, 5 mL
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Quinolone Antimicrobial class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Ophthalmic ofloxacin ophthalmic is used to treat bacterial infections of the eye, including conjunctivitis (pink eye) and ulcers of the cornea. Ofloxacin is in a class of medications called quinolone antibiotics. It works by killing bacterial cells that cause infection.
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Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Ofloxacin — tap one for details:
Ofloxacin may be associated with lower levels of 11 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
4 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ofloxacin 3 mg/mL 64980-0515-01 | Rising | 1 bottle | $1.183 | AT | Availability likely | — |
| Ofloxacin 3 mg/mL 65145-0142-01 | Caplin | 10 ml | $1.183 | AT | Availability likely | — |
| ofloxacin 3 mg/mL 70756-0650-30 | Lifestar | 1 bottle | $1.183 | AT | Availability likely | — |
| ofloxacin 3 mg/mL 00904-7434-05 | Major | 1 bottle | $1.268 | AT | Availability likely | — |
| Ofloxacin 3 mg/mL 24208-0434-05 | Bausch | 1 bottle | $1.268 | AT | Availability likely | — |
| Ofloxacin 3 mg/mL 60505-0560-00 | Apotex | 1 bottle | $1.268 | AT | Availability likely | — |
| Ofloxacin 3 mg/mL 65145-0141-01 | Caplin | 5 ml | $1.268 | AT | Availability likely | — |
| Ofloxacin 3 mg/mL 69315-0327-05 | Leading | 5 ml | $1.268 | AT | Availability likely | — |
| Ofloxacin 3 mg/mL 70069-0411-01 | Somerset | 1 bottle | $1.268 | AT | Availability likely | — |
| Ofloxacin 3 mg/mL 70512-0793-05 | SOLA | 1 bottle | $1.268 | AT | Availability likely | — |
| ofloxacin 3 mg/mL 70756-0607-30 | Lifestar | 1 bottle | $1.268 | AT | Availability likely | — |
| Ofloxacin 3 mg/mL 72485-0613-10 | ARMAS | 1 bottle | $1.268 | AT | Availability likely | — |
| ofloxacin 3 mg/mL 72603-0192-01 | NorthStar | 5 ml | $1.268 | AT | Availability likely | — |
| Ocuflox 3 mg/mL 11980-0779-05 | Allergan, | 1 bottle | — | AT | FDA listed | — |
| Ofloxacin 3 mg/mL 50090-1744-00 | A-S | 1 bottle | — | AT | FDA listed | — |
| Ofloxacin 3 mg/mL 50090-5186-00 | A-S | 1 bottle | — | AT | FDA listed | — |
| Ofloxacin 3 mg/mL 50090-5209-00 | A-S | 1 bottle | — | AT | FDA listed | — |
| Ofloxacin 3 mg/mL 50090-5425-00 | A-S | 1 bottle | — | AT | FDA listed | — |
| ofloxacin 3 mg/mL 50090-6794-00 | A-S | 1 bottle | — | AT | FDA listed | — |
| Ofloxacin 3 mg/mL 50090-7264-00 | A-S | 1 bottle | — | AT | FDA listed | — |
| ofloxacin 3 mg/mL 50090-7761-00 | A-S | 5 ml | — | AT | FDA listed | — |
| Ofloxacin ophthalmic 3 mg/mLthis 59390-0140-05 | Altaire | 5 ml | — | AT | FDA listed | — |
| Ofloxacin 3 mg/mL 60760-0917-05 | St. | 1 bottle | — | AT | FDA listed | — |
| Ofloxacin 3 mg/mL 60760-0970-05 | ST. | 1 bottle | — | AT | FDA listed | — |
| Ofloxacin 3 mg/mL 63187-0268-05 | Proficient | 1 bottle | — | AT | FDA listed | — |
| Ofloxacin 3 mg/mL 63187-0662-05 | Proficient | 1 bottle | — | AT | FDA listed | — |
| Ofloxacin 3 mg/mL 63187-0734-05 | Proficient | 1 bottle | — | AT | FDA listed | — |
| Ofloxacin 3 mg/mL 68071-1607-05 | NuCare | 5 ml | — | AT | FDA listed | — |
| Ofloxacin 3 mg/mL 68071-2254-05 | NuCare | 1 bottle | — | AT | FDA listed | — |
| Ofloxacin 3 mg/mL 68071-2265-01 | NuCare | 1 bottle | — | AT | FDA listed | — |
| ofloxacin 3 mg/mL 68071-3448-05 | NuCare | 1 bottle | — | AT | FDA listed | — |
| Ofloxacin 3 mg/mL 68071-3566-01 | NuCare | 1 bottle | — | AT | FDA listed | — |
| ofloxacin 3 mg/mL 68071-3919-05 | NuCare | 5 ml | — | AT | FDA listed | — |
| Ofloxacin 3 mg/mL 68788-7693-05 | Preferred | 1 bottle | — | AT | FDA listed | — |
| ofloxacin 3 mg/mL 68788-8449-05 | Preferred | 1 bottle | — | AT | FDA listed | — |
| Ofloxacin 3 mg/mL 68788-8761-05 | Preferred | 1 bottle | — | AT | FDA listed | — |
| ofloxacin 3 mg/mL 70518-3710-00 | REMEDYREPACK | 1 bottle | — | AT | FDA listed | — |
| Ofloxacin 3 mg/mL 71205-0420-05 | Proficient | 1 bottle | — | AT | FDA listed | — |
| Ofloxacin Ophth Soln 3 mg/mL 72189-0472-05 | Direct_Rx | 5 ml | — | AT | FDA listed | — |
| ofloxacin 3 mg/mL 82804-0101-05 | Proficient | 1 bottle | — | AT | FDA listed | — |
| Ofloxacin 3 mg/mL 70518-3573-00 | REMEDYREPACK | 1 bottle | — | AT | Discontinued | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 59390-0140-05 You're viewing this | 5 mL in 1 BOTTLE, DROPPER (59390-140-05) | 2013-05-31 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Ofloxacin ophthalmic solution, USP is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below: CONJUNCTIVITIS: Gram-positive bacteria: Gram-negative bacteria: Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumonia Enterobacter cloacae Haemophilus influenza Proteus mirabilis Pseudomonas aeruginosa CORNEAL ULCERS: Gram-positive bacteria: Gram-negative bacteria: Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Pseudomonas aeruginosa Serratia marcascens ' Anaerobic species: Propionibacterium acnes * Efficacy for this organism was studied in fewer than 10 infections
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION The recommended dosage regimen for the treatment of bacterial conjunctivitis is: Days 1 and 2 Instill one to two drops every two to four hours in the affected eye(s). Days 3 through 7 Instill one to two drops four times daily. The recommended dosage regimen for the treatment of bacterial corn eal ulcer is: Days 1 and 2 Instill one to two drops into the affected eye every 30 minutes, while awake.
Awaken at approximately four and six hours after retiring and instill one to two drops. Days 3 through 7 to 9 Instill one to two drops hourly, while awake Days 7 to 9 through treatment completion Instill one to two drops, four times daily.
⛔ Contraindications ▾
CONTRAINDICATIONS Ofloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to ofloxacin, to other quinolones, or to any of the components in this medication.
⚠️ Warnings ▾
WARNINGS NOT FOR INJECTION. Ofloxacin ophthalmic solution should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones, including ofloxacin.
Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. A rare occurrence of Stevens-Johnson syndrome, which progressed to toxic epidermal necrolysis, has been reported in a patient who was receiving topical ophthalmic ofloxacin. If an allergic reaction to ofloxacin occurs, discontinue the drug.
Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management, including intubation should be administered as clinically indicated.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Ophthalmic Use: The most frequently reported drug-related adverse reaction was transient ocular burning or discomfort. Other reported reactions include stinging, redness, itching, chemical conjunctivitis/keratitis, ocular/periocular/facial edema, foreign body sensation, photophobia, blurred vision, tearing, dryness, and eye pain. Rare reports of dizziness and nausea have been received.
🔄 Drug Interactions ▾
Drug Interactions: Specific drug interaction studies have not been conducted with ofloxacin ophthalmic solution. 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 patients receiving cyclosporine concomitantly.
🤰 Pregnancy ▾
Pregnancy: Teratogenic Effects. Pregnancy Category C: Ofloxacin has been shown to have an embryocidal effect in rats and in rabbits when given in doses of 810 mg/kg/day (equivalent to 9000 times the maximum recommended daily ophthalmic dose) and 160 mg/kg/day (equivalent to 1800 times the maximum recommended daily ophthalmic dose). These dosages resulted in decreased fetal body weight and increased fetal mortality in rats and rabbits, respectively.
Minor fetal skeletal variations were reported in rats receiving doses of 810 mg/kg/day. Ofloxacin has not been shown to be teratogenic at doses as high as 810 mg/kg/day and 160 mg/kg/day when administered to pregnant rats and rabbits, respectively.
🧒 Pediatric Use ▾
Pediatric Use: Safety and effectiveness in infants below the age of one year have not been established. Quinolones, including ofloxacin, have been shown to cause arthropathy in immature animals after oral administration; however, topical ocular administration of ofloxacin to immature animals has not shown any arthropathy. There is no evidence that the ophthalmic dosage form of ofloxacin has any effect on weight bearing joints.
🧓 Geriatric Use ▾
Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Pharmacokinetics: Serum, urine and tear concentrations of ofloxacin were measured in 30 healthy women at various time points during a ten-day course of treatment with ofloxacin ophthalmic solution. The mean serum ofloxacin concentration ranged from 0.4 ng/mL to 1.9 ng/mL. Maximum ofloxacin concentration increased from 1.1 ng/mL on day one to 1.9 ng/mL on day 11 after QID dosing for 10 1/2 days.
Maximum serum ofloxacin concentrations after ten days of topical ophthalmic dosing were more than 1000 times lower than those reported after standard oral doses of ofloxacin. Tear ofloxacin concentrations ranged from 5.7 to 31 ug/g during the 40 minute period following the last dose on day 11. Mean tear concentration measured four hours after topical ophthalmic dosing was 9.2 ug/g.
Corneal tissue concentrations of 4.4 ug/mL were observed four hours after beginning topical ocular application of two drops of ofloxacin ophthalmic solution every 30 minutes. Ofloxacin was excreted in the urine primarily unmodified. Microbiology: Ofloxacin has in vitro activity against a broad range of gram-positive and gram-negative aerobic and anaerobic bacteria.
Ofloxacin is bactericidal at concentrations equal to or slightly greater than inhibitory concentrations. Ofloxacin is thought to exert a bactericidal effect on susceptible bacterial cells by inhibiting DNA gyrase, an essential bacterial enzyme which is a critical catalyst in the duplication, transcription, and repair of bacterial DNA. Cross-resistance has been observed between ofloxacin and other fluoroquinolones.
There is generally no cross-resistance between ofloxacin and other classes of antibacterial agents such as beta-lactams or aminoglycosides. Ofloxacin has been shown to be active against most strains of the following organisms both in vitro and clinically, in conjunctival and/or corneal ulcer infections as described in the INDICATIONS AND USAGE section. AEROBES, GRAM-POSITIVE : AEROBES, GRAM-NEGATIVE: Staphylococcus aureus Enterobacter cloacae Staphylococcus epidemidis Haemophilus influenzae Streptococcus pneumonia Proteus mirabilis ANAEROBIC SPECIES: Pseudomonas aeruginos a Propionibacterium acnes Serratia marcescens' *Efficacy for this organism was studied in fewer than 10 infections The safety and effectiveness of ofloxacin ophthalmic solution in treating ophthalmologic infections due to the following organisms have not been established in adequate and well-controlled clinical trials.
Ofloxacin ophthalmic solution has been shown to be active in vitro against most strains of these organisms but the clinical significance in ophthalmologic infections is unknown. AEROBES, GRAM-POSITIVE: Enterococcus faecalis Staphylococcus hominus Listeria monocytogenes Staphylococcus simulans Staphylococcus capitis Streptococcus pyogenes AEROBES, GRAM-NEGATIVE: Acinetobacter calcoaceticus var. anitratus Klebsiella pneumoniae Acinetobacter calcoaceticus var. lwoffii Moraxella (Branhamella) catarrhalis Citrobacter diversus Moraxella lacunata Citrobacter freundii Morganella morganii Enterobacter aerogenes Neisseria gonorrhoeae Enterobacter agglomerans Pseudomonas acidovorans Escherichia coli Pseudomonas fluorescens Haemophilus parainfluenzae Shigella sonnei Klebsiella oxytoca OTHER: Chlamydia trachomatis Clinical Studies: Conjunctivitis: In a randomized, double-masked, multicenter clinical trial, ofloxacin ophthalmic solution was superior to its vehicle after 2 days of treatment in patients with conjunctivitis and positive conjunctival cultures.
Clinical outcomes for the trial demonstrated a clinical improvement rate of 86% (54/63) for the ofloxacin treated group versus 72% (48/67) for the placebo treated group after 2 days of therapy. Microbiological outcomes for the same clinical trial demonstrated an eradication rate for causative pathogens of 65% (41/63) for the ofloxacin treated group versus 25% (17/67) for the vehicle treated group after 2 days of therapy. Please note that microbio…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Ofloxacin ophthalmic solution USP, 0.3% is supplied sterile in opaque white LDPE plastic bottles and natural dropper tips with tan polypropylene caps as follows: 5mL in 10mL bottle - NDC 59390-140-05 Note: Store at 20°-25°C (68°-77°F) Rx only Revised March 2013 Altaire P harmaceuticals Inc. Aquebogue N.Y. 11931, U.S.A.
📋 Description ▾
DESCRIPTION Ofloxacin Ophthalmic Solution USP , 0.3% is a sterile ophthalmic solution. It is a fluorinated carboxyquinolone anti-infective for topical ophthalmic use. Chemical Name: (±)-9-Fiuoro-2, 3-dihydro-3-methyl-10(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4 benzoxazine-6-carboxylic acid.
Contains: Active: ofloxacin 0.3% (3 mg/mL). Preservative: benzalkonium chloride (0.005%). C 18 H 20 FN 3 O 4 Mol Wt.
361.37 Inactives: sodium chloride and purified water. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH. Ofloxacin ophthalmic solution, USP is unbuffered and formulated with a pH of 6.4 (range - 6.0 to 6.8).
It has an osmolality of 300 mOsm/kg. Ofloxacin is a fluorinated 4-quinolone which differs from other fluorinated 4-quinolones in that there is a six member (pyridobenzoxazine) ring from positions 1 to 8 of the basic ring structure.
💬 Information for Patients ▾
Information for Patients: Avoid contaminating the applicator tip with material from the eye, fingers or other source. Systemic quinolones, including ofloxacin, have been associated with hypersensitivity reactions, even following a single dose. Discontinue use immediately and contact your physician at the first sign of a rash or allergic reaction.