LEVOFLOXACIN 5 mg/mL Solution
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Fluoroquinolone Antibacterial class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- Levofloxacin only works against bacterial infections. It won't help with viral infections like colds, flu, or COVID-19. Your doctor prescribed it because you have a specific bacter...
- What is levofloxacin actually treating — is it for any kind of infection?
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- I heard this antibiotic has some serious risks. Should I be worried?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Levofloxacin — tap one for details:
Levofloxacin 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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.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 · Q2 2026 | $9.82 | $49.12 / 5 ml |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Levofloxacin 5 mg/mLthis 72888-0142-22 | Advagen | 1 bottle | — | AT | FDA listed | — |
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
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 72888-0142-22 You're viewing this | 1 BOTTLE in 1 CARTON (72888-142-22) / 5 mL in 1 BOTTLE | 2022-02-22 | 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 | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 ▾
1 INDICATIONS AND USAGE Levofloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Gram-positive bacteria Corynebacterium species * Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumonia Streptococcus (Groups C/F) Streptococcus (Group G) Viridans group streptococci* Gram-negative bacteria Acinetobacter lwoffii * Haemophilus influenzae Serratia marcescens* *Efficacy for this organism was studied in fewer than 10 infections Levofloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Gram-positive bacteria: Corynebacterium species * Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumonia Streptococcus (Groups C/F) Streptococcus (Group G) Viridans group streptococci* Gram-negative bacteria: Acinetobacter lwoffii * Haemophilus influenzae Serratia marcescens* *Efficacy for this organism was studied in fewer than 10 infections ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Days 1 and 2 Instill one to two drops in the affected eye(s) every 2 hours while awake, up to 8 times per day. Days 3 through 7 Instill one to two drops in the affected eye(s) every 4 hours while awake, up to 4 times per day. Day s 1 and 2: Instill one to two drops in the affected eye(s) every 2 hours while awake, up to 8 times per day.
Day s 3 through 7: Instill one to two drops in the affected eye(s) every 4 hours while awake, up to 4 times per day. ( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 5 mL white LDPE bottle filled with 5 mL sterile ophthalmic solution of levofloxacin, 0.5%. 5 mL white LDPE bottle filled with 5 mL sterile ophthalmic solution of levofloxacin, 0.5% ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Levofloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to levofloxacin, to other quinolones, or to any of the components in this medication. Levofloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to levofloxacin, to other quinolones, or to any of the components in this medication. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Hypersensitivity and anaphylaxis have been reported with systemic use of levofloxacin as well as topical use of other fluoroquinolones, including levofloxacin ophthalmic solution. ( 5.1 ) Prolonged use may result in the overgrowth of non- susceptible organisms, including fungi. ( 5.2 ) Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis. ( 5.3 )
5.1Hypersensitivity Reactions In patients receiving systemically administered quinolones, including levofloxacin, serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, some following the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema, (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria and itching. If allergic reaction to levofloxacin occurs, discontinue the drug.
Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management should be administered as clinically indicated.
5.2Growth of Resistant Organisms with Prolonged Use As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit-lamp biomicroscopy, and where appropriate, fluorescein staining.
5.3Avoidance of Contact Lens Wear Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most frequently reported adverse reactions in the overall study population were transient decreased vision, fever, foreign body sensation, headache, transient ocular burning, ocular pain or discomfort, pharyngitis and photophobia. These reactions occurred in approximately 1-3% of patients. Other reported reactions occurring in less than 1% of patients included allergic reactions, lid edema, ocular dryness, and ocular itching.
The most frequently reported adverse reactions in the overall study population were transient decreased vision, fever, foreign body sensation, headache, transient ocular burning, ocular pain or discomfort, pharyngitis and photophobia. These reactions occurred in approximately 1 to 3% of patients. Other reported reactions occurring in less than 1% of patients included allergic reactions, lid edema, ocular dryness, and ocular itching.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Advagen Pharma Ltd, at 866-488-0312 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Teratogenic Effects Levofloxacin at oral doses of 810 mg/kg/day in rats caused decreased fetal body weight and increased fetal mortality. No teratogenic effect was observed when rabbits were dosed orally as high as 50 mg/kg/day, at which systemic exposure was approximately 2,250 times that observed at the maximum recommended human ophthalmic dose, or when dosed intravenously as high as 25 mg/kg/day, at which systemic exposure was approximately 1000 times that observed at the maximum recommended human ophthalmic dose.
There are, however, no adequate and well-controlled studies in pregnant women. Levofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
8.3Nursing Mothers Levofloxacin has not been measured in human milk. Based upon data from ofloxacin, it can be presumed that levofloxacin is excreted in human milk. Caution should be exercised when levofloxacin ophthalmic solution is administered to a nursing mother.
8.4Pediatric Use Safety and effectiveness in children below the age of six years have not been established. Oral administration of systemic quinolones has been shown to cause arthropathy in immature animals. There is no evidence that the ophthalmic administration of levofloxacin has any effect on weight bearing joints.
8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
🤰 Pregnancy ▾
8.1Pregnancy Teratogenic Effects Levofloxacin at oral doses of 810 mg/kg/day in rats caused decreased fetal body weight and increased fetal mortality. No teratogenic effect was observed when rabbits were dosed orally as high as 50 mg/kg/day, at which systemic exposure was approximately 2,250 times that observed at the maximum recommended human ophthalmic dose, or when dosed intravenously as high as 25 mg/kg/day, at which systemic exposure was approximately 1000 times that observed at the maximum recommended human ophthalmic dose.
There are, however, no adequate and well-controlled studies in pregnant women. Levofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness in children below the age of six years have not been established. Oral administration of systemic quinolones has been shown to cause arthropathy in immature animals. There is no evidence that the ophthalmic administration of levofloxacin has any effect on weight bearing joints.
🧓 Geriatric Use ▾
8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Levofloxacin is a member of the fluoroquinolone class of anti-infective drugs. (See
12.4 Microbiology )
12.2Pharmacokinetics Levofloxacin concentration in plasma was measured in 15 healthy adult volunteers at various time points during a 15-day course of treatment with levofloxacin ophthalmic solution. The mean levofloxacin concentration in plasma 1 hour postdose, ranged from 0.86 ng/mL on Day 1 to 2.05 ng/mL on Day 15. The highest maximum mean levofloxacin concentration of 2.25 ng/mL was measured on Day 4 following 2 days of dosing every 2 hours for a total of 8 doses per day.
Maximum mean levofloxacin concentrations increased from 0.94 ng/mL on Day 1 to 2.15 ng/mL on Day 15, which is more than 1,000 times lower than those reported after standard oral doses of levofloxacin. Levofloxacin concentration in tears was measured in 30 healthy adult volunteers at various time points following instillation of a single drop of levofloxacin ophthalmic solution. Mean levofloxacin concentrations in tears ranged from 34.9 to 221.1 mcg/mL during the 60-minute period following the single dose.
The mean tear concentrations measured 4 and 6 hours postdose were 17.0 and 6.6 mcg/mL. The clinical significance of these concentrations is unknown.
12.3Microbiology Levofloxacin is the L-isomer of the racemate, ofloxacin, a quinolone antimicrobial agent. The antibacterial activity of ofloxacin resides primarily in the L-isomer. The mechanism of action of levofloxacin and other fluoroquinolone antimicrobials involves the inhibition of bacterial topoisomerase IV and DNA gyrase (both of which are type II topoisomerases), enzymes required for DNA replication, transcription, repair, and recombination.
Levofloxacin has in vitro activity against a wide range of Gram-negative and Gram-positive microorganisms and is often bactericidal at concentrations equal to or slightly greater than inhibitory concentrations. Fluoroquinolones, including levofloxacin, differ in chemical structure and mode of action from β- lactam antibiotics and aminoglycosides, and therefore may be active against bacteria resistant to β- lactam antibiotics and aminoglycosides. Additionally, β-lactam antibiotics and aminoglycosides may be active against bacteria resistant to levofloxacin.
Resistance to levofloxacin due to spontaneous mutation i n vitro is a rare occurrence (range: 10 -9 to 10 -10 ) Levofloxacin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section: Aerobic gram-positive microorganisms Corynebacterium species* Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumonia Streptococcus (Groups C/F) Streptococcus (Group G) Viridans group streptococci* Aerobic gram-negative microorganisms Acinetobacter lwoffii* Haemophilus influenzae Serratia marcescens* *Efficacy for this organism was studied in fewer than 10 infections.
The following i n vitro data are also available, but their clinical significance in ophthalmic infections is unknown. The safety and effectiveness of levofloxacin in treating ophthalmological infections due to these microorganisms have not been established in adequate and well- controlled trials. These organisms are considered susceptible when evaluated using systemic breakpoints.
However, a correlation between the in vitro systemic breakpoint and ophthalmological efficacy has not been established. The list of organisms is provided as guidance only in assessing the potential treatment of conjunctival infections. Levofloxacin exhibits in vitro minimal inhibitory concentrations (MICs) of 2 mcg/mL or less (systemic susceptible breakpoint) against most (≥90%) strains of the following ocular pathogens: Aerobicgram-positive microorganisms Enterococcus faecalis Staphylococcus saprophyticus Streptococcus agalactiae Streptococcus pyogenes Aerobic gram-negative microorganisms Acinetobacter an…
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE HANDLING Levofloxacin Ophthalmic Solution, 0.5% is a clear light yellow solution supplied in a white LDPE bottle with translucent LDPE nozzle and tan coloured HDPE cap in the following size: 5 mL filled in 5 mL bottle – NDC 72888-142-22 Storage: Store at 20º to 25°C (68º to 77°F) [See USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION Levofloxacin Ophthalmic Solution, 0.5% is a sterile topical ophthalmic solution. Levofloxacin is a fluoroquinolone antibacterial active against a broad spectrum of Gram-positive and Gram-negative ocular pathogens. Levofloxacin is a fluorinated 4-quinolone containing a six-member (pyridobenzoxazine) ring from positions 1 to 8 of the basic ring structure.
Levofloxacin is the pure (-)-(S)-enantiomer of the racemic drug substance, ofloxacin. It is more soluble in water at neutral pH than ofloxacin. Chemical Name: (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido [1,2,3-de]-1,4 benzoxazine-6-carboxylic acid hemihydrate.
Levofloxacin (hemihydrate) is a light yellow powder. Each mL of levofloxacin ophthalmic solution, 0.5% contains 5.12 mg of levofloxacin hemihydrate equivalent to 5 mg levofloxacin. Contains Levofloxacin 5 mg equivalent to 5.12 mg levofloxacin hemihydrate with benzalkonium chloride 0.005%, sodium chloride, water for injection, hydrochloric acid and/or sodium hydroxide (to adjust pH).
Levofloxacin ophthalmic solution, 0.5% is isotonic and formulated at pH 6.0-6.8 with an osmolality between 285-315 mOsm/kg. Levofloxacin Ophthalmic Solution, 0.5% is a sterile topical ophthalmic solution. Levofloxacin is a fluoroquinolone antibacterial active against a broad spectrum of Gram-positive and Gram-negative ocul
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION
17.1Avoid Contamination of the Product Advise patients to avoid contaminating the applicator tip with material from the eye, finger, or other source.
17.2Avoid Contact Lens Wear Advise patients not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis.
17.3Hypersensitivity Reactions Systemically administered quinolones, including levofloxacin, have been associated with hypersensitivity reactions, even following a single dose. Advise patients to discontinue use immediately and contact their physician at the first sign of a rash or allergic reaction. Distributed by: Advagen Pharma Ltd., East Windsor, NJ 08520, USA Rev. 02/2025