XTORO finafloxacin 3 mg/mL Suspension
🆔 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
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Finafloxacin — tap one for details:
Finafloxacin may be associated with lower levels of 7 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 F5UM2KM3W7
Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
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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 L605B5892V
A plant-derived thickener made from cellulose. It increases the medicine's thickness and helps it spread evenly, commonly used in gels, creams, and eye drops to improve texture and how the product coats or clings to surfaces.
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UNII 02F3473H9O
A mineral salt used in medications as a source of magnesium. It helps bind ingredients together, improve texture, and maintain the product's stability during storage.
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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 Y27PUL9H56
Tyloxapol is a synthetic detergent and surfactant used in medications as a solubilizer and emulsifier. It helps dissolve or blend ingredients that don't naturally mix well, improving how the medicine disperses in liquid formulations.
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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.
8 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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💲 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 |
|---|---|---|---|---|---|---|
| Xtoro 3 mg/mLthis 83709-0001-01 | Fonseca | 1 bottle | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 8536167 ↗ | Method of use | U-1679 | Aug 8, 2031 |
| US 9504691 ↗ | Method of use | U-1679 | Nov 21, 2033 |
| US 9119859 ↗ | Method of use | U-1679 | Jul 2, 2030 |
| US 9993483 ↗ | Drug product | — | Jul 2, 2030 |
Is there a generic version of XTORO 0.3% EAR DROP?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 83709-0001-01 You're viewing this | 1 BOTTLE, DROPPER in 1 CARTON (83709-001-01) / 5 mL in 1 BOTTLE, DROPPER | 2026-05-01 | Active |
| 83709-0001-90 | 1 POUCH in 1 CARTON (83709-001-90) / 1 BOTTLE, DROPPER in 1 POUCH / 1.5 mL in 1 BOTTLE, DROPPER | 2026-05-01 | Active |
| 83709-0001-91 | 1 BOTTLE, DROPPER in 1 CARTON (83709-001-91) / 5 mL in 1 BOTTLE, DROPPER | 2026-05-01 | Active |
Pack size FAQ
What quantity is in NDC 83709-0001-01?
What NDC number is used to bill for this package of XTORO finafloxacin 3 mg/mL Suspension?
🧭 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?
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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 XTORO® is indicated for the treatment of acute otitis externa (AOE) with or without an otowick, caused by susceptible strains of Pseudomonas aeruginosa and Staphylococcus aureus in patients age 1 year and older. XTORO® is a quinolone antimicrobial indicated for the treatment of acute otitis externa (AOE) caused by susceptible strains of Pseudomonas aeruginosa and Staphylococcus aureus . ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Instill four drops into the affected ear(s) twice daily for seven days. For patients requiring use of an otowick, the initial dose can be doubled (to 8 drops), followed by 4 drops instilled into the affected ear twice daily for seven days. Important administration instructions include: Warm the suspension by holding the bottle in the hand for one or two minutes prior to dosing in order to avoid dizziness which may result from the instillation of a cold suspension.
Shake bottle well before use. Lie with the affected ear upward, instill the drops, and maintain the position for 60 seconds to facilitate penetration of the drops into the ear canal. Repeat if necessary for the opposite ear.
Instill four drops in the affected ear(s) twice daily for seven days. For patients requiring use of an otowick, the initial dose can be doubled (to 8 drops), followed by 4 drops instilled into the affected ear twice daily for seven days. ( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Otic Suspension: Each mL of XTORO contains finafloxacin 0.3% (equivalent to 3 mg finafloxacin). Otic Suspension: finafloxacin 0.3% ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Prolonged use of this product may lead to overgrowth of nonsusceptible organisms. Discontinue use if this occurs. ( 5.1 ) Allergic reactions may occur in patients with a history of hypersensitivity to finafloxacin, to other quinolones, or to any of the components in this medication. Discontinue use if this occurs. ( 5.2 )
5.1Growth of Resistant Organisms with Prolonged Use As with other antibacterial preparations, prolonged use of XTORO may lead to overgrowth of nonsusceptible organisms, including yeast and fungi. If this occurs, discontinue use and institute alternative therapy.
5.2Allergic Reactions Allergic reactions to XTORO may occur in patients with a history of hypersensitivity to finafloxacin, to other quinolones, or to any of the components in this medication. If this occurs, discontinue use and institute alternative therapy.
5.1Growth of Resistant Organisms with Prolonged Use As with other antibacterial preparations, prolonged use of XTORO may lead to overgrowth of nonsusceptible organisms, including yeast and fungi. If this occurs, discontinue use and institute alternative therapy.
5.2Allergic Reactions Allergic reactions to XTORO may occur in patients with a history of hypersensitivity to finafloxacin, to other quinolones, or to any of the components in this medication. If this occurs, discontinue use and institute alternative therapy.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most common adverse reactions occurring in 1% of patients with XTORO were ear pruritus and nausea. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fonseca Biosciences, LLC at 1-877-436-6732 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 618 patients were treated with XTORO in two Phase 3 clinical trials. The most frequently reported adverse reactions of those exposed to XTORO occurring at an incidence of 1% included ear pruritus and nausea.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no adequate or well-controlled studies with XTORO in pregnant women. Finafloxacin was shown to be teratogenic in rabbits and rats following oral administration. Neural tube defects and skeletal anomalies in both species, and limb anomalies in rabbits, were observed at exposures estimated to be at least 1300 times the maximum human systemic exposure following topical otic administration of 0.3% finafloxacin.
Because animal studies are not always predictive of human responses, XTORO should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Data Animal Data In rabbit embryofetal studies, maternal toxicity was not observed at oral doses up to 9 mg/kg/day (estimated 8000 times the maximum human systemic exposure [0.234 ng/mL] following topical otic administration with 0.3% finafloxacin). Fetal toxicity was observed at the lowest dose tested, 1 mg/kg/day (estimated 1300 times the maximum human systemic exposure following topical otic administration with 0.3% finafloxacin), and included exencephaly, enlarged fontanel, spina bifida, phocomelia, paw hyperflexure, missing lumbar vertebra, missing lumbar arch, and sternebra fusion.
In a rat embryofetal study, no adverse maternal toxicity was observed at oral doses up to 100 mg/kg/day (estimated 60,000 times the maximum human systemic exposure following topical otic administration with 0.3% finafloxacin). The developmental no observed adverse effect level (NOAEL) was 30 mg/kg (estimated 22,000 times the maximum human systemic exposure following topical otic administration with 0.3% finafloxacin). Exencephaly was observed in one fetus at 100 mg/kg.
At 500 mg/kg, additional developmental toxicities were observed including increased preimplantation loss, decreased fetal weight, decreased placental weight, increased incidence of non-ossified sternebrae, and delayed ossifications in the sternebrae, xiphisternum, sacral arches and metacarpals.
8.2Lactation Finafloxacin has been identified in the milk of nursing rats following oral administration. The human systemic concentration of XTORO following topical otic treatment is low [see Clinical Pharmacology ( 12.3 )] . It is not known whether topical otic administration could result in sufficient systemic absorption to produce detectable quantities in the human breast milk.
Caution should be exercised when finafloxacin is administered to a nursing mother.
8.4Pediatric Use The safety and efficacy of XTORO in infants below one year of age have not been established. The safety and efficacy of XTORO in treating acute otitis externa in pediatric patients one year or older have been demonstrated in adequate and well controlled clinical trials [see Clinical Studies ( 14 )].
8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no adequate or well-controlled studies with XTORO in pregnant women. Finafloxacin was shown to be teratogenic in rabbits and rats following oral administration. Neural tube defects and skeletal anomalies in both species, and limb anomalies in rabbits, were observed at exposures estimated to be at least 1300 times the maximum human systemic exposure following topical otic administration of 0.3% finafloxacin.
Because animal studies are not always predictive of human responses, XTORO should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Data Animal Data In rabbit embryofetal studies, maternal toxicity was not observed at oral doses up to 9 mg/kg/day (estimated 8000 times the maximum human systemic exposure [0.234 ng/mL] following topical otic administration with 0.3% finafloxacin). Fetal toxicity was observed at the lowest dose tested, 1 mg/kg/day (estimated 1300 times the maximum human systemic exposure following topical otic administration with 0.3% finafloxacin), and included exencephaly, enlarged fontanel, spina bifida, phocomelia, paw hyperflexure, missing lumbar vertebra, missing lumbar arch, and sternebra fusion.
In a rat embryofetal study, no adverse maternal toxicity was observed at oral doses up to 100 mg/kg/day (estimated 60,000 times the maximum human systemic exposure following topical otic administration with 0.3% finafloxacin). The developmental no observed adverse effect level (NOAEL) was 30 mg/kg (estimated 22,000 times the maximum human systemic exposure following topical otic administration with 0.3% finafloxacin). Exencephaly was observed in one fetus at 100 mg/kg.
At 500 mg/kg, additional developmental toxicities were observed including increased preimplantation loss, decreased fetal weight, decreased placental weight, increased incidence of non-ossified sternebrae, and delayed ossifications in the sternebrae, xiphisternum, sacral arches and metacarpals.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and efficacy of XTORO in infants below one year of age have not been established. The safety and efficacy of XTORO in treating acute otitis externa in pediatric patients one year or older have been demonstrated in adequate and well controlled clinical trials [see Clinical Studies ( 14 )].
🧓 Geriatric Use ▾
8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Finafloxacin is a fluoroquinolone antimicrobial [see Microbiology ( 12.4 )] .
12.3Pharmacokinetics Finafloxacin plasma concentrations were evaluated following single or repeated ototopical doses of XTORO (finafloxacin otic suspension) 0.3%. In healthy subjects administered 4 drops in each ear twice daily for seven days, quantifiable finafloxacin concentrations were observed in 2 of 14 subjects; and these concentrations were just above the quantitation limit (0.05 ng/mL). Similarly, in AOE patients administered a single dose of 4 or 8 drops in each ear, quantifiable finafloxacin concentrations of up to 0.234 ng/mL were observed in plasma samples from 2 of 36 AOE patients.
12.4Microbiology Finafloxacin belongs to the fluoroquinolone class of antibacterials which involves the inhibition of bacterial type II topoisomerase enzymes, DNA gyrase and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair and recombination. Finafloxacin has been shown to be active against most isolates of the following bacteria, both in vitro and clinical studies as described in the INDICATIONS and USAGE section of the package insert for XTORO Pseudomonas aeruginosa Staphylococcus aureus Mechanism of Resistance Resistance to fluoroquinolones occurs primarily by mutations in the chromosomal DNA that encode for DNA gyrase and DNA topoisomerase enzymes, decreased outer membrane permeability or drug efflux mechanisms.
In vitro resistance to finafloxacin due to spontaneous mutation is rare. Cross Resistance Cross-resistance has been observed between finafloxacin and other fluoroquinolones. No cross-resistance has been observed between finafloxacin and other classes of antibacterial agents.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Finafloxacin is a fluoroquinolone antimicrobial [see Microbiology ( 12.4 )] .
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING XTORO (finafloxacin otic suspension) 0.3% is a sterile, preserved, aqueous, otic suspension supplied in an opaque plastic bottle with a controlled drop tip and a white cap: 5 mL fill in a 5 mL bottle (NDC 83709-001-01) Storage and Handling Store at 2°C to 25°C (36°F to 77°F). Do not freeze.
📋 Description ▾
11 DESCRIPTION XTORO (finafloxacin otic suspension) 0.3% is a quinolone antimicrobial. Its chemical name is (-)-8-cyano-1-cyclopropyl-6-fluoro-7-[(4a S ,7a S )-hexahydropyrrolo[3,4- b ]-1,4-oxazin-6(2 H )-yl]- 4-oxo-1,4-dihydroquinoline-3-carboxylic acid (CAS number 209342-40-5). Its structural formula is: Finafloxacin has a molecular weight of 398.4.
Finafloxacin is a white to yellow powder or crystals that is slightly soluble in water (0.125 mg/mL). XTORO (finafloxacin otic suspension), 0.3% is supplied as a sterile, preserved, aqueous suspension for topical otic use. It has a pH of approximately 6.0 and an osmolality of approximately 290 mOsm/kg.
XTORO contains Active ingredient: finafloxacin, 0.3%. Preservative: benzalkonium chloride (0.005%). Inactive ingredients include: sodium chloride, hydroxyethylcellulose, tyloxapol, magnesium chloride, and purified water.
May contain hydrochloric acid and/or sodium hydroxide to adjust pH.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Allergic Reactions Advise patients that if a rash or allergic reaction occurs, they should discontinue the use of the product immediately and contact their physician. Warm the Bottle in Hands Before Use Advise patients or caregivers that prior to administration of XTORO, they should warm the bottle by holding it in their hands for one or two minutes to avoid dizziness which may result from the instillation of a cold solution. For Use with an Otowick Advise patients that following instillation of 8 drops at the time of otowick insertion, they should continue with the lower dose of 4 drops administered twice daily for seven days.
U.S. Patents Nos: 8,536,167; 9,119,859; 9,504,691; 9,993,483 ©2026 Fonseca Biosciences, LLC Manufactured For: Fonseca Biosciences, LLC 2807 Long Beach Blvd Ste 1A Long Beach Township, New Jersey 08008 USA 1-877-436-6732 [email protected]