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Ciprofloxacin Otic .5 mg/.25mL Solution/ Drops, 14 vials — NDC 64950-0381-14 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Ciprofloxacin Otic .5 mg/.25mL Solution/ Drops, 14 vials — NDC 64950-381-14 (Billing 64950-0381-14)

by Genus Lifesciences · 14 VIAL in 1 CARTON / .25 mL in 1 VIAL

This is a package of 14 vials of Ciprofloxacin Otic .5 mg/.25mL Solution/ Drops from Genus Lifesciences, marketed since Dec 2024 and currently FDA-listed, this package's marketing is listed to end Nov 2028; retail pharmacies pay about $6.35 per vial (NADAC). It is this product's only package size.

NDC 64950-0381-14
🏷️ FDA NDC (as labeled) 64950-381-14 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

NDC database record

One package, one record: these facts belong to NDC 64950-381-14 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
64950 labeler · 381 product · 14 package
Package marketed since
Dec 1, 2024
Package marketing ended
Nov 30, 2028
Sample package
No — commercial package
Billing quantity
14 EA per package
Barcode (UPC-A, from the NDC)
3 6495038114 6
Medicaid fills, this package
410 prescriptions in the last four reported quarters
FDA record last changed
Oct 8, 2026
⚠️
Other active recalls for Ciprofloxacin (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 11, 2025 — Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle (FDC Limited) · FDA recall D-0282-2025
Class II · Dec 16, 2024 — Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle (FDC Limited) · FDA recall D-0182-2025
Class II · Jul 23, 2024 — Defective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle. (FDC Limited) · FDA recall D-0623-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 64950-381-14
Product NDC 64950-381
11-digit billing NDC 64950038114
NCPDP billing unit EA — each (per item)
Application # ANDA217887
SPL Set ID 51dde3f2-adb1-4ed8-83c6-1f63723a2529
Established class (EPC) Fluoroquinolone Antibacterial
Mechanism of action Cytochrome P450 1A2 Inhibitors
Chemical class Fluoroquinolones
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-12-01
Marketing end 2028-11-30
Route AURICULAR (OTIC)
Dosage form SOLUTION/ DROPS
Substance CIPROFLOXACIN
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 065259
GCN 24946
HICL code 004124
Ingredient (HICL) Ciprofloxacin Hcl
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q8
Therapeutic class — intermediate (HIC2) Otic Preparations
HIC3 code Q8W
Therapeutic class — specific (HIC3) Ear Preparations,Antibiotics
AHFS code 08:12.18.00
AHFS class Quinolone Antibiotics
FDB label name CIPROFLOXACIN 0.2% OTIC SOLN
FDB brand name Ciprofloxacin Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 065259
  • GCN: 24946
  • HICL (First Databank): 004124
  • AHFS class code: 08:12.18.00
Why two NDCs? The FDA registers this code as 64950-381-14 — 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 → 64950-0381-14. 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.

Clinical

Label name CIPROFLOXACIN 0.2% OTIC SOLN Ingredient Ciprofloxacin Hcl
📖 What it is MedlinePlus · NLM

Ciprofloxacin otic solution (Cetraxal) and ciprofloxacin otic suspension (Otiprio) are used to treat outer ear infections in adults and children. Ciprofloxacin otic suspension (Otiprio) is also used in children during ear tube placement surgery to prevent infection or ear drainage. Ciprofloxacin otic is in a class of medications called quinolone antibiotics. It works by killing the bacteria that cause infection.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats bacterial infections such as urinary tract, respiratory, skin, bone and abdominal infections, depending on the form. Eye and ear versions treat eye and ear infections. It...
  • Swallow them as prescribed, usually every 12 hours, and finish the full course unless your doctor says otherwise. Keep them 2 hours before or 6 hours after antacids, multivitamins,...
  • How should I take my ciprofloxacin tablets?
  • The most common ones are nausea, diarrhea, vomiting, rash and abnormal liver tests. Most are mild, but tell your doctor if they bother you.
📖 Read our full Ciprofloxacin guide →
11
Nutrient depletion considerations

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

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 eaPer package
Retail pharmacies payNADAC · weekly $6.352 $88.93 / 14 vials
Medicaid paysCMS SDUD · 12 mo $7.00 $97.94 / 14 vials
Medicare drug plans payPart D · Q2 2026 $5.83 $81.66 / 14 vials
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $7.032 $6.352
▼ Down 9% over the last 10 months.
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
64950-0381-14 You're viewing this Main listing 14 VIAL in 1 CARTON / .25 mL in 1 VIAL 2024-12-01 Nov 30, 2028 Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ciprofloxacin Otic .5 mg/.25mLthis 64950-0381-14 Genus 14 vials $6.352 AB Availability likely —
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

🏛️
2024
On the market since
Dec 2024
📍
2026
Currently FDA-listed
2 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.

🧪 Avoiding an ingredient? See Ciprofloxacin inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 33X04XA5AT
    Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • 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.
  • 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.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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?
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

LabelerGenus Lifesciences
Application holderALEMBIC THERAPEUTICS LLC
FDA applicationANDA217887 (ANDA)
Labeler code64950
First marketedDec 2024
Product typeHuman Prescription Drug
Portfolio25 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. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 61 words ▾

1 INDICATIONS AND USAGE Ciprofloxacin otic solution, 0.2% is a quinolone antimicrobial indicated for the treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus . Ciprofloxacin otic solution, 0.2% is a quinolone antimicrobial indicated for the treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus . ( 1 )

⏱️ Dosage and Administration 138 words ▾

2 DOSAGE AND ADMINISTRATION The contents of one single-dose container (deliverable volume: 0.25 mL) should be instilled into the affected ear twice daily (approximately 12 hours apart) for 7 days. Wash hands before use. The solution should be warmed, by holding the container in the hands for at least 1 minute, to minimize the dizziness that may result from the instillation of a cold solution into the ear canal.

The patient should lie with the affected ear upward and then the solution should be instilled. This position should be maintained for at least 1 minute to facilitate penetration of the drops into the ear. Repeat, if necessary, for the opposite ear.

Discard unused portion. Contents of one single-dose container should be instilled into the affected ear twice daily (approximately 12 hours apart) for 7 days. ( 2 )

💊 Dosage Forms and Strengths 62 words ▾

3 DOSAGE FORMS AND STRENGTHS Ciprofloxacin otic solution, 0.2% is a sterile, preservative-free, otic solution of ciprofloxacin hydrochloride equivalent to 0.2 % ciprofloxacin (0.5 mg in 0.25 mL) in each single-dose container. Ciprofloxacin otic solution, 0.2% is a sterile, preservative-free otic solution of ciprofloxacin hydrochloride equivalent to 0.2 % ciprofloxacin (0.5 mg in 0.25 mL) in each single-dose container. ( 3 )

⛔ Contraindications 25 words ▾

4 CONTRAINDICATIONS Ciprofloxacin otic solution, 0.2% is contraindicated in persons with a history of hypersensitivity to ciprofloxacin. History of hypersensitivity to ciprofloxacin. ( 3 )

⚠️ Warnings and Cautions 161 words ▾

5 WARNINGS AND PRECAUTIONS Ciprofloxacin otic solution, 0.2% is for otic use only. ( 5.1 ) Hypersensitivity: discontinue at the first appearance of a skin rash or any other sign of hypersensitivity. ( 5.2 ) Use of ciprofloxacin otic solution, 0.2% may result in overgrowth of nonsusceptible organisms. ( 5.3 )

5.1Otic Use Only Ciprofloxacin otic solution, 0.2% is for otic use only. It should not be used for injection, for inhalation or for topical ophthalmic use.

5.2Hypersensitivity Ciprofloxacin otic solution, 0.2% should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity.

5.3Growth of Rsistant Organisms with Prolonged Use As with other anti-infectives, use of ciprofloxacin otic solution, 0.2% may result in overgrowth of nonsusceptible organisms, including yeast and fungi. If super-infection occurs, discontinue use and institute alternative therapy.

5.4Lack of Clinical Response If the infection is not improved after one week of therapy, cultures may help guide further treatment.

🤒 Adverse Reactions 144 words ▾

6 ADVERSE REACTIONS Because clinical studies are conducted under widely varying conditions, adverse drug reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. In a randomized, active-controlled clinical trial, approximately 300 patients with clinical signs and symptoms of otitis externa were treated with ciprofloxacin otic solution, 0.2%. The most frequently reported adverse reactions were application site pain, ear pruritus, fungal ear superinfection, and headache, each reported in approximately 2-3% of patients.

The most common adverse reactions reported in 2-3% of patients treated with ciprofloxacin otic solution, 0.2% were application site pain, ear pruritus, fungal ear superinfection and headache. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Allucent at 1-866-511-6754 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . ( 6 )

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Category C. Reproduction studies have been performed in rats and mice using oral doses of up to 100 mg/kg and intravenous (IV) doses up to 30 mg/kg and have revealed no evidence of harm to the fetus as a result of ciprofloxacin. In rabbits, ciprofloxacin (30 and 100 mg/kg orally) produced gastrointestinal disturbances resulting in maternal weight loss and an increased incidence of abortion, but no teratogenicity was observed at either dose.

After intravenous administration of doses up to 20 mg/kg, no maternal toxicity was produced in the rabbit, and no embryotoxicity or teratogenicity was observed. Animal reproduction studies have not been conducted with ciprofloxacin otic solution, 0.2%. No adequate and well controlled studies have been performed in pregnant women.

Caution should be exercised when ciprofloxacin otic solution, 0.2% is used by a pregnant woman.

8.3Nursing Mothers Ciprofloxacin is excreted in human milk with systemic use. It is not known whether ciprofloxacin is excreted in human milk following otic use. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

8.4Pediatric Use The safety and effectiveness of ciprofloxacin otic solution, 0.2% in infants below one year of age have not been established. The efficacy of ciprofloxacin otic solution, 0.2% in treating otitis externa in pediatric patients one year or older has been demonstrated in controlled clinical trials (see Section 14 Clinical Studies ). There is no evidence that the otic administration of quinolones has any effect on weight bearing joints, even though systemic administration of some quinolones has been shown to cause arthropathy in immature animals.

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

🤰 Pregnancy 138 words ▾

8.1Pregnancy Pregnancy Category C. Reproduction studies have been performed in rats and mice using oral doses of up to 100 mg/kg and intravenous (IV) doses up to 30 mg/kg and have revealed no evidence of harm to the fetus as a result of ciprofloxacin. In rabbits, ciprofloxacin (30 and 100 mg/kg orally) produced gastrointestinal disturbances resulting in maternal weight loss and an increased incidence of abortion, but no teratogenicity was observed at either dose.

After intravenous administration of doses up to 20 mg/kg, no maternal toxicity was produced in the rabbit, and no embryotoxicity or teratogenicity was observed. Animal reproduction studies have not been conducted with ciprofloxacin otic solution, 0.2%. No adequate and well controlled studies have been performed in pregnant women.

Caution should be exercised when ciprofloxacin otic solution, 0.2% is used by a pregnant woman.

🧒 Pediatric Use 87 words ▾

8.4Pediatric Use The safety and effectiveness of ciprofloxacin otic solution, 0.2% in infants below one year of age have not been established. The efficacy of ciprofloxacin otic solution, 0.2% in treating otitis externa in pediatric patients one year or older has been demonstrated in controlled clinical trials (see Section 14 Clinical Studies ). There is no evidence that the otic administration of quinolones has any effect on weight bearing joints, even though systemic administration of some quinolones has been shown to cause arthropathy in immature animals.

🧓 Geriatric Use 18 words ▾

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

🧬 Clinical Pharmacology 180 words ▾

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action Ciprofloxacin is a fluoroquinolone antimicrobial (see

12.4Clinical Pharmacology, Microbiology ).

12.3Pharmacokinetics The plasma concentrations of ciprofloxacin were not measured following administration of 0.25 mL ciprofloxacin otic solution, 0.2% (total dose: 0.5 mg ciprofloxacin). However, the maximum plasma concentration of ciprofloxacin is anticipated to be less than 5 ng/mL.

12.4Microbiology The bactericidal action of ciprofloxacin results from interference with the enzyme DNA gyrase, which is needed for the synthesis of bacterial DNA. Bacterial resistance to quinolones can develop through chromosomally- or plasmid-mediated mechanisms. The mechanism of action of fluoroquinolones, including ciprofloxacin, is different from that of macrolides.

Therefore, ciprofloxacin may be active against pathogens that are resistant to these antibiotics, and these antibiotics may be active against pathogens that are resistant to ciprofloxacin. In vitro studies demonstrated cross-resistance between ciprofloxacin and some fluoroquinolones. Ciprofloxacin has been shown to be active against most isolates of the following bacteria, both in vitro and in clinical infections of acute otitis externa as described in Section 1 Indications and Usage.

Staphylococcus aureus Pseudomonas aeruginosa .

🧬 Mechanism of Action 15 words ▾

12.1 Mechanism of Action Ciprofloxacin is a fluoroquinolone antimicrobial (see

12.4Clinical Pharmacology, Microbiology ).

📦 How Supplied / Storage and Handling 83 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Ciprofloxacin otic solution, 0.2% is a clear, colorless, sterile, preservative-free solution. Ciprofloxacin otic solution, 0.2% is supplied as a 0.2% otic solution in a low-density polyethylene (LDPE) single-dose container. Each single-dose container delivers 0.25 mL of solution equivalent to 0.5 mg of ciprofloxacin; 14 single-dose containers are packaged in a foil overwrap pouch in a carton (NDC 64950-381-14).

Store at 15°C to 25°C (59°F to 77°F). Discard used containers. Store unused containers in pouch to protect from light.

📦 Storage and Handling 20 words ▾

Store at 15°C to 25°C (59°F to 77°F). Discard used containers. Store unused containers in pouch to protect from light.

📋 Description 107 words ▾

11 DESCRIPTION Ciprofloxacin otic solution, 0.2% contains the synthetic antimicrobial agent ciprofloxacin hydrochloride. Ciprofloxacin otic solution, 0.2% is a sterile, preservative-free solution for otic use. Each single-dose container of ciprofloxacin otic solution, 0.2% delivers 0.25 mL of solution equivalent to 0.5 mg of ciprofloxacin.

The inactive ingredients are povidone, glycerin, and water for injection. Sodium hydroxide and/or lactic acid may be added to adjust pH. Ciprofloxacin, a fluroquinolone is available as the monohydrochloride, monohydrate salt of 1cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid.

Its molecular formula is C 17 H 18 FN 3 O 3 ∙HCl∙H 2 O, and molecular weight is 385.82. The chemical structure of ciprofloxacin hydrochloride is: Chemical Structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION

17.1Directions for Use Patients should be advised that ciprofloxacin otic solution, 0.2% is for otic use only. It is not for ophthalmic or inhalation use. It is not for injection.

Ciprofloxacin otic solution, 0.2% should be given 2 times each day (about 12 hours apart) in each infected ear. Ciprofloxacin otic solution, 0.2% should be used for as long as it is prescribed, even if the symptoms improve. The patient should be advised to follow these directions while on ciprofloxacin otic solution, 0.2%: Wash their hands before use.

Warm the container in their hands for at least one minute prior to use to minimize dizziness that may result from the instillation of a cold solution into the ear canal. Twist off and discard top of container. Lie with the affected ear upward and then instill the contents of one container into the ear.

Maintain this position for at least one minute to facilitate penetration of the drops into the ear. Repeat, if necessary, for the opposite ear. Discard used container.

Store unused containers in pouch to protect from light. Image Image Image

17.2Hypersensitivity Patients should be advised to immediately discontinue ciprofloxacin otic solution, 0.2% at the first appearance of a skin rash or any other sign of hypersensitivity [see Section

5.1Warnings and Precautions ].

🍼 Nursing Mothers 62 words ▾

8.3Nursing Mothers Ciprofloxacin is excreted in human milk with systemic use. It is not known whether ciprofloxacin is excreted in human milk following otic use. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

🧬 Pharmacokinetics 39 words ▾

12.3Pharmacokinetics The plasma concentrations of ciprofloxacin were not measured following administration of 0.25 mL ciprofloxacin otic solution, 0.2% (total dose: 0.5 mg ciprofloxacin). However, the maximum plasma concentration of ciprofloxacin is anticipated to be less than 5 ng/mL.

🔬 Clinical Studies 78 words ▾

14 CLINICAL STUDIES In a randomized, multi-center, evaluator-blinded study of patients with acute otitis externa, patients were treated with either ciprofloxacin otic solution, 0.2% twice daily or neomycin and polymyxin B sulfates and hydrocortisone otic solution (PNH) three times daily for 7 days. In the per protocol population, clinical cure was achieved at the end of a 7-day treatment in 70% (173/247) for the ciprofloxacin otic solution, 0.2% treated group versus 60% (147/243) for the control treated group.

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term carcinogenicity studies in mice and rats have been completed for ciprofloxacin. After daily oral doses of 750 mg/kg (mice) and 250 mg/kg (rats) were administered for up to 2 years, there was no evidence that ciprofloxacin had any carcinogenic or tumorigenic effects in these species. No long-term studies of ciprofloxacin otic solution, 0.2% have been performed to evaluate carcinogenic potential.

Eight in vitro mutagenicity tests have been conducted with ciprofloxacin, and the test results are listed below: Salmonella/ Microsome Test (Negative) Escherichia coli DNA Repair Assay (Negative) Mouse Lymphoma Cell Forward Mutation Assay (Positive) Chinese Hamster V79 Cell HGPRT Test (Negative) Syrian Hamster Embryo Cell Transformation Assay (Negative) Saccharomyces cerevisiae Point Mutation Assay (Negative) Saccharomyces cerevisiae Mitotic Crossover and Gene Conversion Assay (Negative) Rat Hepatocyte DNA Repair Assay (Positive).

Two of the 8 in vitro tests were positive, but results of the following 3 in vivo test systems gave negative results: Rat Hepatocyte DNA Repair Assay Micronucleus Test (Mice) Dominant Lethal Test (Mice). Fertility studies performed in rats at oral doses of ciprofloxacin up to 100 mg/kg/day revealed no evidence of impairment. This would be over 100 times the maximum recommended clinical dose of ototopical ciprofloxacin based upon body surface area, assuming total absorption of ciprofloxacin from the ear of a patient treated with ciprofloxacin otic solution, 0.2% twice per day.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term carcinogenicity studies in mice and rats have been completed for ciprofloxacin. After daily oral doses of 750 mg/kg (mice) and 250 mg/kg (rats) were administered for up to 2 years, there was no evidence that ciprofloxacin had any carcinogenic or tumorigenic effects in these species. No long-term studies of ciprofloxacin otic solution, 0.2% have been performed to evaluate carcinogenic potential.

Eight in vitro mutagenicity tests have been conducted with ciprofloxacin, and the test results are listed below: Salmonella/ Microsome Test (Negative) Escherichia coli DNA Repair Assay (Negative) Mouse Lymphoma Cell Forward Mutation Assay (Positive) Chinese Hamster V79 Cell HGPRT Test (Negative) Syrian Hamster Embryo Cell Transformation Assay (Negative) Saccharomyces cerevisiae Point Mutation Assay (Negative) Saccharomyces cerevisiae Mitotic Crossover and Gene Conversion Assay (Negative) Rat Hepatocyte DNA Repair Assay (Positive).

Two of the 8 in vitro tests were positive, but results of the following 3 in vivo test systems gave negative results: Rat Hepatocyte DNA Repair Assay Micronucleus Test (Mice) Dominant Lethal Test (Mice). Fertility studies performed in rats at oral doses of ciprofloxacin up to 100 mg/kg/day revealed no evidence of impairment. This would be over 100 times the maximum recommended clinical dose of ototopical ciprofloxacin based upon body surface area, assuming total absorption of ciprofloxacin from the ear of a patient treated with ciprofloxacin otic solution, 0.2% twice per day.

📄 Package Label / Principal Display Panel 87 words ▾

PRINCIPAL DISPLAY PANEL - 14 Vial Carton NDC 64950-381-14 Sterile Preservative-Free Ciprofloxacin Otic Solution, 0.2% Containers not for individual sale. Discard used containers. Store at 15°C to 25°C (59°F to 77°F).

Store unused containers in pouch to protect from light. Contents: 14 single-dose containers, 0.25 mL each (deliverable volume) OTIC USE USE IN EARS ONLY Manufactured for: Genus Lifesciences Inc. Allentown, PA 18102 Manufactured by: Holopack Verpackungstechnik GmbH Sulzbach-Laufen, Germany 74429 Origin Germany Rev 12/2024 Genus Lifesciences Inc.

Rx Only Principal Display Panel - 14 Vial Carton

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q3 2025 – Q1 2026 · 3 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
410
Units reimbursed last 4 qtrs
5.6K
Gross reimbursed last 4 qtrs
$38.9K
Avg / prescription
$94.99
Avg / unit
$6.9960
Latest quarter Q1 2026
181Rx
Medicaid pays / ea
$6.9960
gross reimbursed
vs
NADAC / ea
$6.3519
acquisition cost
=
Spread
+$0.6441
+10% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
60% FFS 40% MCO
Fee-for-service · 247 Rx Managed care · 163 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 308 units · 1.6 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: 560 units · 9.5 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 238 units · 2.7 per 100k residents VA Maryland: 926 units · 15.0 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 1,250 units · 16.8 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 1,750 units · 24.6 per 100k residents TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: 354 units · 6.9 per 100k residents AL Georgia: 182 units · 1.7 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
1.624.6
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Tennessee 24.6 /100k
2 Arizona 16.8 /100k
3 Maryland 15.0 /100k
4 Colorado 9.5 /100k
5 Alabama 6.9 /100k
6 Virginia 2.7 /100k
7 Georgia 1.7 /100k
8 New York 1.6 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Cipro (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Cipro. 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
$92.9K
Claims incl. refills
550
Beneficiaries
474
Spend / beneficiary
$196.00
Spend / claim
$168.91
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.
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.