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LEVOFLOXACIN 15 mg/mL Solution/ Drops — NDC 42571-168-25 (Billing 42571-0168-25)

by Micro Labs Limited · 1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE

This is a package of LEVOFLOXACIN 15 mg/mL Solution/ Drops from Micro Labs Limited, no longer marketed (first marketed Apr 2019), no longer in the FDA NDC Directory. It is this product's only package size.

NDC 42571-0168-25
🏷️ FDA NDC (as labeled) 42571-168-25 billing pads the product segment with a zero
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Aug 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 42571-168-25
Product NDC 42571-168
11-digit billing NDC 42571016825
RxCUI 545118
UNII 6GNT3Y5LMF
Application # ANDA205600
SPL Set ID c0417827-3c49-4dbd-97a8-3e2bb509d157
Established class (EPC) Fluoroquinolone Antibacterial
Chemical class Fluoroquinolones
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Aug 2026)
Marketing start 2019-04-16
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance LEVOFLOXACIN
Quick answers
  • RxCUI (RxNorm): 545118
Why two NDCs? The FDA registers this code as 42571-168-25 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 42571-0168-25. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Fluoroquinolone Antibacterial class.

Pharmacologic class Fluoroquinolone Antibacterial
Drug family (ATC) Fluoroquinolones, Fluoroquinolones
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It treats bacterial infections such as pneumonia, skin, urinary tract, prostate and sinus infections, and is used after anthrax exposure and for plague. The eye drops treat bacteri...
  • Tablets and oral solution are taken by mouth, usually once a day. Take it exactly as prescribed and finish the course. Keep it at least 2 hours apart from antacids, magnesium and s...
  • Nausea, headache, diarrhea, trouble sleeping, constipation and dizziness are the most common. Most are manageable, but let me know if they bother you.
  • Stop and call right away for tendon pain or swelling, tingling or numbness, new anxiety, confusion or mood changes, rash or swelling, severe diarrhea, or yellow skin or eyes. These...
📖 Read our full Levofloxacin guide →
11
Nutrient depletion considerations

Levofloxacin may be associated with lower levels of 11 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Levofloxacin nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer mLPer 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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
42571-0168-25 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE 2019-04-16 — Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Levofloxacin 15 mg/mLthis 42571-0168-25 Micro 1 bottle — — Discontinued —
Levofloxacin 15 mg/mL 54288-0140-01 BPI 5 ml — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2019
On the market since
Apr 2019
📍
2026
Currently FDA-listed
7 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured 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?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerMicro Labs Limited
Application holderMICRO LABS LTD INDIA
FDA applicationANDA205600 (ANDA)
Labeler code42571
First marketedApr 2019
Product typeHuman Prescription Drug
Portfolio190 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 105 words ▾

1 INDICATIONS AND USAGE Levofloxacin ophthalmic solution is indicated for the treatment of corneal ulcer caused by susceptible strains of the following bacteria: Gram-positive bacteria: Corynebacterium species Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumonia Viridans group streptococci* Gram-negative bacteria: Pseudomonas aeruginosa Serratia marcescens* * Efficacy for this organism was studied in fewer than 10 infections Levofloxacin ophthalmic solution is a topical quinolone anti-microbial indicated for the treatment of corneal ulcer caused by susceptible strains of the following bacteria: Corynebacterium species * Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumonia Viridans group streptococci* Pseudomonas aeruginosa Serratia marcescens* *Efficacy for this organism was studied in fewer than 10 infections.

(1)

⏱️ Dosage and Administration 105 words ▾

2 DOSAGE AND ADMINISTRATION Days 1 through 3: Instill one to two drops in the affected eye(s) every 30 minutes to 2 hours while awake and approximately 4 and 6 hours after retiring. Day 4 through treatment completion: Instill one to two drops in the affected eye(s) very 1 to 4 hours while awake. Days 1 through 3: Instill one to two drops in the affected eye(s) every 30 minutes to 2 hours while awake and approximately 4 and 6 hours after retiring.

Day 4 through treatment completion: Instill one to two drops in the affected eye(s) every 1 to 4 hours while awake. (2)

💊 Dosage Forms and Strengths 32 words ▾

3 DOSAGE FORMS AND STRENGTHS 5 cc bottle filled with 5 mL sterile ophthalmic solution of levofloxacin, 1.5%. 5 cc container filled with 5 mL sterile ophthalmic solution of levofloxacin, 1.5% (3)

⛔ Contraindications 55 words ▾

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 203 words ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity and anaphylaxis have been reported with systemic use of levofloxacin. (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 corneal ulcer. (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 an 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 corneal ulcer.

🤒 Adverse Reactions 133 words ▾

6 ADVERSE REACTIONS The most frequently reported adverse reactions in the overall study population were headache and a taste disturbance following instillation. These reactions occurred in approximately 8 to 10% of patients. Adverse reactions occurring in approximately 1 to 2% of patients included decreased/blurred vision, diarrhea, dyspepsia, fever, infection, instillation site irritation/discomfort, ocular infection, nausea, ocular pain/discomfort, and throat irritation.

Other reported ocular reactions occurring in less than 1% of patients included chemosis, corneal erosion, diplopia, floaters, hyperemia, lid edema, and lid erythema. The most frequently reported adverse reactions in the overall study population were headache and a taste disturbance following instillation. These reactions occurred in approximately 8 to 10% of patients.

(6) To report SUSPECTED ADVERSE REACTIONS, contact Micro Labs USA, Inc. at 1-855-839-8195 or FDA at 1-800-FDA-1088 or ww w.fda.gov/medwatch .

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Category C 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 estimated to be 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 estimated to be 120 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 on data from ofloxacin, it can be presumed that levofloxacin is excreted in human milk. Caution should be exercised when levofloxacin 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 116 words ▾

8.1Pregnancy Pregnancy Category C 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 estimated to be 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 estimated to be 120 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 49 words ▾

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 19 words ▾

8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

🆘 Overdosage 2 words ▾

10 OVERDOSAGE

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Levofloxacin is a member of the fluoroquinolone class of anti-microbial drug (See

12.4Microbiology) .

12.3Pharmacokinetics Levofloxacin concentration in plasma was measured in 14 healthy adult volunteers during a 16-day course of treatment with levofloxacin ophthalmic solution. The dosing schedule was 1 to 2 drops per eye once in the morning on Days 1 and 16; 1 to 2 drops per eye every two hours Days 2 through 8; and 1 to 2 per eye every four hours Days 9 through 15. The mean levofloxacin concentration in plasma 1 hour post dose ranged from 3.13 ng/mL on Day 1 to 10.4 ng/mL on Day 16.

Maximum mean levofloxacin concentrations increased from 3.22 ng/mL on Day 1 to 10.9 ng/mL on Day 16, which is more than 400 times lower than those reported after standard oral doses of levofloxacin. Levofloxacin concentration in tears was measured in 100 healthy adult volunteers at various time points following instillation of 2 drops of levofloxacin ophthalmic solution. Mean tear concentration measured 15 minutes after instillation was 757 mcg/mL.

12.4Microbiology 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 ß-lactam antibiotics and aminoglycosides, and therefore may be active against bacteria resistant to ß-lactam antibiotics and aminoglycosides. Additionally, ß-lactam antibiotics and aminoglycosides may be active against bacteria resistant to levofloxacin.

Resistance to levofloxacin due to spontaneous mutation in 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 pneumoniae Viridans group streptococci* Aerobic gram-negative microorganisms: Pseudomonas aeruginosa Serratia marcescens* *Efficacy for this organism was studied in fewer than 10 infections.

The following in 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 corneal ulcer. 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: Aerobic gram-positive microorganisms: Enterococcus faecalis (many strains are only moderately susceptible) Staphylococcus saprophyticus Streptococcus agalactiae Streptococcus pyogenes Streptococcus (Group C/F) Streptococcus (Group G) Aerobic gram-negative microorganisms: Acinetobacter baumannii Acinetobacter lwoffii Citrobacter koseri Citrobacter freundii Enterobacter aerogenes Enterobacter cloacae Escherichia coli Haemophilus influenzae Haemophilus parainfluenza… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 19 words ▾

12.1Mechanism of Action Levofloxacin is a member of the fluoroquinolone class of anti-microbial drug (See

12.4Microbiology) .

📦 How Supplied / Storage and Handling 69 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Levofloxacin ophthalmic solution 1.5% is supplied in a sterile with a white opaque cylindrical shaped low density polyethylene bottle with an open white opaque cone shaped low density polyethylene controlled dropper tip and a tan color cone shaped high density polyethylene cap in the following size: 5 mL fill in 5 cc container– NDC 42571-168-25 Storage: Store at 15° to 25°C (59° to 77°F).

📋 Description 165 words ▾

11 DESCRIPTION Levofloxacin ophthalmic solution 1.5% 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. C 18 H 20 FN 3 O 4 ·½ H2O Mol Wt 370.38 Chemical Name: (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7 H - pyrido[1,2,3- de ]-1,4 benzoxazine-6-carboxylic acid hemihydrate.

Levofloxacin (hemihydrate) USP is a yellowish-white crystalline powder. Each mL of levofloxacin ophthalmic solution contains 15.36 mg of levofloxacin hemihydrate USP equivalent to 15 mg levofloxacin. Contains: Active: Levofloxacin (hemihydrate) USP is a light yellowish-white; Inactives: glycerin and water for injection.

May also contain hydrochloric acid and/or sodium hydroxide to adjust pH to approximately 6.7. Levofloxacin ophthalmic solution is isotonic with an osmolality of approximately 291 mOsm/kg. levofloxacin structure

💬 Information for Patients 87 words ▾

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 corneal ulcer.

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 reactions.

🍼 Nursing Mothers 39 words ▾

8.3Nursing Mothers Levofloxacin has not been measured in human milk. Based on data from ofloxacin, it can be presumed that levofloxacin is excreted in human milk. Caution should be exercised when levofloxacin is administered to a nursing mother.

🧬 Pharmacokinetics 159 words ▾

12.3Pharmacokinetics Levofloxacin concentration in plasma was measured in 14 healthy adult volunteers during a 16-day course of treatment with levofloxacin ophthalmic solution. The dosing schedule was 1 to 2 drops per eye once in the morning on Days 1 and 16; 1 to 2 drops per eye every two hours Days 2 through 8; and 1 to 2 per eye every four hours Days 9 through 15. The mean levofloxacin concentration in plasma 1 hour post dose ranged from 3.13 ng/mL on Day 1 to 10.4 ng/mL on Day 16.

Maximum mean levofloxacin concentrations increased from 3.22 ng/mL on Day 1 to 10.9 ng/mL on Day 16, which is more than 400 times lower than those reported after standard oral doses of levofloxacin. Levofloxacin concentration in tears was measured in 100 healthy adult volunteers at various time points following instillation of 2 drops of levofloxacin ophthalmic solution. Mean tear concentration measured 15 minutes after instillation was 757 mcg/mL.

🔬 Clinical Studies 108 words ▾

14 CLINICAL STUDIES In two randomized, double-masked, multi-center, controlled clinical trials of 280 patients with positive cultures, subjects were dosed with levofloxacin or ofloxacin 0.3% ophthalmic solution. Dosing occurred on Days 1 through 3 every two hours while awake and 4 and 6 hours after retiring. Dosing occurred on Day 4 through treatment completion 4 times daily while awake.

Clinical cure was defined as complete re-epithelialization and no progression of the infiltrate for two consecutive visits. The levofloxacin treated subjects had an approximately equal mean clinical cure rate of 80% (73% to 87%) compared to 84% (82% to 86%) for the subjects treated with ofloxacin 0.3% ophthalmic solution.

🧪 Nonclinical Toxicology 153 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a long term carcinogenicity study in rats, levofloxacin exhibited no carcinogenic or tumorigenic potential following daily dietary administration for 2 years at doses up to 100 mg/kg/day, corresponding to plasma levels that were 245 times maximum clinical exposure, based on C max . Levofloxacin was not mutagenic in the following assays: Ames bacterial mutation assay (S. typhimurium and E. coli) CHO/HGPRT forward mutation assay, mouse micronucleus test, mouse dominant lethal test, rat unscheduled DNA synthesis assay, and the in vivo mouse sister chromatid exchange assay.

It was positive in the in vitro chromosomal aberration (CHL cell line) and in vitro sister chromatid exchange (CHL/IU cell line) assays. Levofloxacin caused no impairment of fertility or reproduction in rats at oral doses as high as 360 mg/kg/day, at which systemic exposure was estimated to be 2,600 times that at the maximum recommended human ophthalmic dose.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 150 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In a long term carcinogenicity study in rats, levofloxacin exhibited no carcinogenic or tumorigenic potential following daily dietary administration for 2 years at doses up to 100 mg/kg/day, corresponding to plasma levels that were 245 times maximum clinical exposure, based on C max . Levofloxacin was not mutagenic in the following assays: Ames bacterial mutation assay (S. typhimurium and E. coli) CHO/HGPRT forward mutation assay, mouse micronucleus test, mouse dominant lethal test, rat unscheduled DNA synthesis assay, and the in vivo mouse sister chromatid exchange assay.

It was positive in the in vitro chromosomal aberration (CHL cell line) and in vitro sister chromatid exchange (CHL/IU cell line) assays. Levofloxacin caused no impairment of fertility or reproduction in rats at oral doses as high as 360 mg/kg/day, at which systemic exposure was estimated to be 2,600 times that at the maximum recommended human ophthalmic dose.

📄 Package Label / Principal Display Panel 44 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Rx Only NDC 42571-168-25 Levofloxacin Ophthalmic Solution 1.5% FOR TOPICAL APPLICATION IN THE EYE 5 mL MICRO LABS NDC 42571-168-25 Levofloxacin Ophthalmic Solution 1.5% FOR TOPICAL APPLICATION IN THE EYE Rx Only 5 mL MICRO LABS vial label carton label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Levofloxacin — the program that covers self-administered drugs. 10 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Levofloxacin. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$4.19M
Claims incl. refills
615.6K
Beneficiaries
533.8K
Spend / beneficiary
$7.85
Spend / claim
$6.81
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Who lists this product with the FDA?
Micro Labs Limited is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 42571-0164-47 · Micro 42571-0169-55 · Micro →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.