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Ofloxacin 3 mg/mL Solution — NDC 24208-410-05 (Billing 24208-0410-05)

by Bausch & Lomb Incorporated · 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER

This is a package of Ofloxacin 3 mg/mL Solution from Bausch & Lomb Incorporated, marketed since Mar 2008 and currently FDA-listed; retail pharmacies pay about $1.11 per mL (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 24208-0410-05
🏷️ FDA NDC (as labeled) 24208-410-05 billing pads the product segment with a zero
This package
Contains5 mL in 1 bottle, dropper Cost per mL$1.11 NADAC Per package$5.55 / 5 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $3.43/unit · Part D plans $2.37/unit — full pricing hub ↓
Main listing for product 24208-410 · Also comes in: 10 mL 24208-410-10
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 →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 24208-410-05 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
24208 labeler · 410 product · 05 package
Package marketed since
Mar 17, 2008
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 2420841005 9
Medicaid fills, this package
6,248 prescriptions in the last four reported quarters
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 24208-410-05
Product NDC 24208-410
11-digit billing NDC 24208041005
NCPDP billing unit ML — per mL (volume)
RxCUI 242446
UNII A4P49JAZ9H
Application # ANDA076128
SPL Set ID c5484f1a-2321-453f-9469-dfcf709e2e2e
Established class (EPC) Quinolone Antimicrobial
Chemical class Quinolones
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2008-03-17
Route AURICULAR (OTIC)
Dosage form SOLUTION
Substance OFLOXACIN
TE code (Orange Book) AT · RLD · RS

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

GPI-14 87100060002010
GPI class Ofloxacin
GCN Seq No 048292
GCN 13880
HICL code 006035
Ingredient (HICL) Ofloxacin
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 OFLOXACIN 0.3% EAR DROPS
FDB brand name Ofloxacin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 048292
  • GCN: 13880
  • GPI-14 (Medi-Span): 87100060002010
  • HICL (First Databank): 006035
  • AHFS class code: 08:12.18.00
  • RxCUI (RxNorm): 242446
Why two NDCs? The FDA registers this code as 24208-410-05 — 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 → 24208-0410-05. 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 Quinolone Antimicrobial class.

Pharmacologic class Quinolone Antimicrobial
Drug family (ATC) Fluoroquinolones, Fluoroquinolones, Antiinfectives
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

Label name OFLOXACIN 0.3% EAR DROPS Ingredient Ofloxacin
📖 What it is MedlinePlus · NLM

Ofloxacin otic is used to treat outer ear infections in adults and children, chronic (long-lasting) middle ear infections in adults and children with a perforated eardrum (a condition where the eardrum has a hole in it), and acute (suddenly occurring) middle ear infections in children with ear tubes. Ofloxacin 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 is an antibiotic for certain bacterial infections. Tablets treat things like pneumonia, skin infections, and some urethral and cervical infections. Eye drops treat bacterial con...
  • Follow the schedule on your label. Tablets are usually taken about every 12 hours. Keep antacids, iron, and zinc multivitamins at least two hours before or after. For ear drops, wa...
  • With the tablets, the most common are nausea, headache, trouble sleeping, dizziness, and diarrhea. Women may also notice vaginal itching. These are often mild, but tell me if they...
  • Stop the medicine and call if you have tendon pain or swelling, tingling or numbness, confusion, hallucinations, or a rash or swelling. Also call for severe diarrhea or sudden seve...
📖 Read our full Ofloxacin guide →
11
Nutrient depletion considerations

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

🧪 Full Ofloxacin 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 $1.110 $5.55 / 5 ml
Medicaid paysCMS SDUD · 12 mo $3.43 $17.15 / 5 ml
Medicare drug plans payPart D · Q2 2026 $2.37 $11.84 / 5 ml
NADAC price history (per mL) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $2.411 $1.072
▼ Down 50% over the last 24 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 Per unit Per pack Marketing startMarketing endStatus
24208-0410-05 You're viewing this Main listing 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER $1.11 / mL $5.55 2008-03-17 — Active
24208-0410-10 24208-410-10 1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER $0.9790 / mL $9.79 2008-03-17 — Active

Per mL, this pack runs about 13% above the cheapest pack (NDC 24208-0410-10, $0.9790 vs $1.11 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 78% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle, dropper in 1 carton / 5 ml in 1 bottle, dropper.
What NDC number is used to bill for this package of Ofloxacin 3 mg/mL Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ofloxacin 3 mg/mL 64980-0432-01 Rising 1 bottle $0.979 AT Availability likely save 12%
Ofloxacin 3 mg/mL 65145-0144-01 Caplin 1 bottle $0.979 AT Availability likely save 12%
Ofloxacin 3 mg/mL 69238-1616-06 Amneal 1 bottle $0.979 AT Availability likely save 12%
Ofloxacin 3 mg/mL 70069-0687-01 Somerset 1 bottle $0.979 AT Availability likely save 12%
ofloxacin 3 mg/mL 70756-0610-30 Lifestar 10 ml $0.979 AT Availability likely save 12%
Ofloxacin 3 mg/mLthis 24208-0410-05 Bausch 1 bottle $1.110 AT Availability likely —
Ofloxacin Otic 3 mg/mL 60505-0363-01 Apotex 5 ml $1.110 AT Availability likely —
Ofloxacin 3 mg/mL 65145-0143-01 Caplin 1 bottle $1.110 AT Availability likely —
Ofloxacin 3 mg/mL 69238-1615-03 Amneal 1 bottle $1.110 AT Availability likely —
Ofloxacin 3 mg/mL 69315-0320-05 Leading 5 ml $1.110 AT Availability likely —
Ofloxacin 3 mg/mL 70069-0686-01 Somerset 1 bottle $1.110 AT Availability likely —
ofloxacin 3 mg/mL 70756-0609-15 Lifestar 5 ml $1.110 AT Availability likely —
ofloxacin 3 mg/mL 72603-0186-01 NorthStar 5 ml $1.110 AT Availability likely —
Ofloxacin Otic 3 mg/mL 50090-1090-00 A-S 5 ml — AT FDA listed —
Ofloxacin 3 mg/mL 50090-5670-00 A-S 1 bottle — AT FDA listed —
ofloxacin 3 mg/mL 50090-7207-00 A-S 5 ml — AT FDA listed —
Ofloxacin Otic 3 mg/mL 63187-0184-05 Proficient 5 ml — AT FDA listed —
Ofloxacin 3 mg/mL 63187-0472-05 Proficient 1 bottle — AT FDA listed —
Ofloxacin Otic 3 mg/mL 63629-8716-01 Bryant 5 ml — AT FDA listed —
Ofloxacin 3 mg/mL 67296-1925-01 Redpharm 1 bottle — AT FDA listed —
Ofloxacin 3 mg/mL 67296-2159-05 Redpharm 5 ml — AT FDA listed —
Ofloxacin 3 mg/mL 67296-2179-05 Redpharm 1 bottle — AT FDA listed —
Ofloxacin Otic 3 mg/mL 68071-1588-05 NuCare 5 ml — AT FDA listed —
Ofloxacin Otic 3 mg/mL 68071-1630-03 NuCare 10 ml — AT FDA listed —
ofloxacin 3 mg/mL 68071-3604-03 NuCare 10 ml — AT FDA listed —
Ofloxacin 3 mg/mL 68788-4086-01 Preferred 1 bottle — AT FDA listed —
ofloxacin 3 mg/mL 68788-8551-01 Preferred 10 ml — AT Discontinued —
ofloxacin 3 mg/mL 70518-3984-00 REMEDYREPACK 5 ml — AT FDA listed —
Ofloxacin Otic 3 mg/mL 70518-4226-00 REMEDYREPACK 5 ml — AT FDA listed —
Ofloxacin Otic 3 mg/mL 71335-2822-01 Bryant 5 ml — AT FDA listed —
Ofloxacin Otic 3 mg/mL 72162-1709-02 Bryant 5 ml — AT FDA listed —
Ofloxacin Otic 3 mg/mL 72189-0108-05 DIRECT 5 ml — AT FDA listed —
Olfoxacin Otic Soln 3 mg/mL 72189-0490-05 Direct_Rx 5 ml — AT FDA listed —
ofloxacin 3 mg/mL 76420-0748-05 Asclemed 5 ml — AT FDA listed —
ofloxacin 3 mg/mL 76420-0749-10 Asclemed 10 ml — AT FDA listed —
ofloxacin 3 mg/mL 82804-0061-05 Proficient 5 ml — AT FDA listed —
Ofloxacin 3 mg/mL 70518-4752-00 REMEDYREPACK 1 bottle — AT 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

🏛️
2008
On the market since
Mar 2008
📍
2026
Currently FDA-listed
18 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 Ofloxacin 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.

  • 0.2 mg / 1 mL 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.
  • 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.
  • 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.
  • 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

LabelerBausch & Lomb Incorporated
Application holderBAUSCH AND LOMB INC
FDA applicationANDA076128 (ANDA)
Labeler code24208
First marketedMar 2008
Product typeHuman Prescription Drug
Portfolio92 products on file

More NDCs from Bausch & Lomb Incorporated labeler code 24208

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 ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🧒 Pediatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 105 words ▾

INDICATIONS AND USAGE Ofloxacin otic solution, 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: Otitis Externa in adults and pediatric patients, 6 months and older, due to Escherichia coli , Pseudomonas aeruginosa and Staphylococcus aureus . Chronic Suppurative Otitis Media in patients 12 years and older with perforated tympanic membranes due to Proteus mirabilis , Pseudomonas aeruginosa and Staphylococcus aureus .

Acute Otitis Media in pediatric patients one year and older with tympanostomy tubes due to Haemophilus influenzae , Moraxella catarrhalis , Pseudomonas aeruginosa , Staphylococcus aureus and Streptococcus pneumoniae .

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION Otitis Externa: The recommended dosage regimen for the treatment of otitis externa is: For pediatric patients (from 6 months to 13 years old): Five drops (0.25 mL, 0.75 mg ofloxacin) instilled into the affected ear once daily for seven days. For patients 13 years and older: Ten drops (0.5 mL, 1.5 mg ofloxacin) instilled into the affected ear once daily for seven days. The solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness which may result from the instillation of a cold solution.

The patient should lie with the affected ear upward, and then the drops should be instilled. This position should be maintained for five minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear.

Acute Otitis Media in pediatric patients with tympanostomy tubes: The recommended dosage regimen for the treatment of acute otitis media in pediatric patients (from 1 to 12 years old) with tympanostomy tubes is: Five drops (0.25 mL, 0.75 mg ofloxacin) instilled into the affected ear twice daily for ten days. The solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness which may result from the instillation of a cold solution. The patient should lie with the affected ear upward, and then the drops should be instilled.

The tragus should then be pumped 4 times by pushing inward to facilitate penetration of the drops into the middle ear. This position should be maintained for five minutes. Repeat, if necessary, for the opposite ear.

Chronic Suppurative Otitis Media with perforated tympanic membranes: The recommended dosage regimen for the treatment of chronic suppurative otitis media with perforated tympanic membranes in patients 12 years and older is: Ten drops (0.5 mL, 1.5 mg ofloxacin) instilled into the affected ear twice daily for fourteen days. The solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness which may result from the instillation of a cold solution. The patient should lie with the affected ear upward, before instilling the drops.

The tragus should then be pumped 4 times by pushing inward to facilitate penetration into the middle ear. This position should be maintained for five minutes. Repeat, if necessary, for the opposite ear.

⛔ Contraindications 28 words ▾

CONTRAINDICATIONS Ofloxacin otic solution, 0.3% is contraindicated in patients with a history of hypersensitivity to ofloxacin, to other quinolones, or to any of the components in this medication.

⚠️ Warnings 85 words ▾

WARNINGS NOT FOR OPHTHALMIC USE. NOT FOR INJECTION. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones, including ofloxacin.

Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. If an allergic reaction to ofloxacin is suspected, stop the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment.

Oxygen and airway management, including intubation, should be administered as clinically indicated.

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS Subjects with Otitis Externa In the phase III clinical trials performed in support of once-daily dosing, 799 subjects with otitis externa and intact tympanic membranes were treated with ofloxacin otic solution. The studies, which served as the basis for approval, were 020 (pediatric, adolescents and adults), 016 (adolescents and adults) and 017 (pediatric). The following treatment-related adverse events occurred in two or more of the subjects: Incidence Rate Adverse Event Studies 002/003* BID (N=229) Studies 016/017* QD (N=310) Study 020* QD (N=489) Application Site Reaction 3% 16.8% 0.6% Pruritus 4% 1.2% 1.0% Earache 1% 0.6% 0.8% Dizziness 1% 0.0% 0.6% Headache 0% 0.3% 0.2% Vertigo 1% 0.0% 0.0% * Studies 002/003 (BID) and 016/017 (QD) were active-controlled and comparative.

Study 020 (QD) was open and non-comparative. An unexpected increased incidence of application site reaction was seen in studies 016/017 and was similar for both ofloxacin and the active control drug (neomycin-polymyxin B sulfate-hydrocortisone). This finding is believed to be the result of specific questioning of the subjects regarding the incidence of application site reactions.

In once daily dosing studies, there were also single reports of nausea, seborrhea, transient loss of hearing, tinnitus, otitis externa, otitis media, tremor, hypertension and fungal infection. In twice daily dosing studies, the following treatment-related adverse events were each reported in a single subject: dermatitis, eczema, erythematous rash, follicular rash, hypoaesthesia, tinnitus, dyspepsia, hot flushes, flushing and otorrhagia. Subjects with Acute Otitis Media with Tympanostomy Tubes (AOM TT) and Subjects with Chronic Suppurative Otitis Media (CSOM) with Perforated Tympanic Membranes: In phase III clinical trials which formed the basis for approval, the following treatment-related adverse events occurred in 1% or more of the 656 subjects with non-intact tympanic membranes in AOM TT or CSOM treated twice daily with ofloxacin otic solution: Adverse Event Incidence (N=656) Taste Perversion Earache Pruritus Paraesthesia Rash Dizziness 7% 1% 1% 1% 1% 1% Other treatment-related adverse reactions reported in subjects with non-intact tympanic membranes included: diarrhea (0.6%), nausea (0.3%), vomiting (0.3%), dry mouth (0.5%), headache (0.3%), vertigo (0.5%), otorrhagia (0.6%), tinnitus (0.3%), and fever (0.3%).

The following treatment-related adverse events were each reported in a single subject: application site reaction, otitis externa, urticaria, abdominal pain, dysaesthesia, hyperkinesia, halitosis, inflammation, pain, insomnia, coughing, pharyngitis, rhinitis, sinusitis, and tachycardia. Post-Marketing Adverse Events Cases of uncommon transient neuropsychiatric disturbances have been included in spontaneous post-marketing reports. A causal relationship with ofloxacin otic solution, 0.3% is unknown.

To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 15 words ▾

Drug Interactions: Specific drug interaction studies have not been conducted with ofloxacin otic solution, 0.3%.

🧒 Pediatric Use 171 words ▾

Pediatric Use: Safety and efficacy have been demonstrated in pediatric patients of the following ages for the listed indications: ■ six months and older: otitis externa with intact tympanic membranes ■ one year and older: acute otitis media with tympanostomy tubes ■ twelve years and older: chronic suppurative otitis media with perforated tympanic membranes Safety and efficacy in pediatric patients below these ages have not been established. Although no data are available on patients less than age 6 months, there are no known safety concerns or differences in the disease process in this population that will preclude use of this product.

No changes in hearing function occurred in 30 pediatric subjects treated with ofloxacin otic and tested for audiometric parameters. Although quinolones, including ofloxacin, have been shown to cause arthropathy in immature animals after systemic administration, young growing guinea pigs dosed in the middle ear with 0.3% ofloxacin otic solution for one month showed no systemic effects, quinolone-induced lesions, erosions of the cartilage in weight-bearing joints, or other signs of arthropathy.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY Pharmacokinetics: Drug concentrations in serum (in subjects with tympanostomy tubes and perforated tympanic membranes), in otorrhea, and in mucosa of the middle ear (in subjects with perforated tympanic membranes) were determined following otic administration of ofloxacin solution. In two single-dose studies, mean ofloxacin serum concentrations were low in adult patients with tympanostomy tubes, with and without otorrhea, after otic administration of a 0.3% solution (4.1 ng/mL (n=3) and 5.4 ng/mL (n=5), respectively).

In adults with perforated tympanic membranes, the maximum serum drug level of ofloxacin detected was 10 ng/mL after administration of a 0.3% solution. Ofloxacin was detectable in the middle ear mucosa of some adult subjects with perforated tympanic membranes (11 of 16 subjects). The variability of ofloxacin concentration in middle ear mucosa was high.

The concentrations ranged from 1.2 to 602 mcg/g after otic administration of a 0.3% solution. Ofloxacin was present in high concentrations in otorrhea (389 - 2850 mcg/g, n=13) 30 minutes after otic administration of a 0.3% solution in subjects with chronic suppurative otitis media and perforated tympanic membranes. However, the measurement of ofloxacin in the otorrhea does not necessarily reflect the exposure of the middle ear to ofloxacin.

Microbiology: Ofloxacin has in vitro activity against a wide range of gram-negative and gram-positive microorganisms. Ofloxacin exerts its antibacterial activity by inhibiting DNA gyrase, a bacterial topoisomerase. DNA gyrase is an essential enzyme which controls DNA topology and assists in DNA replication, repair, deactivation, and transcription.

Cross-resistance has been observed between ofloxacin and other fluoroquinolones. There is generally no cross-resistance between ofloxacin and other classes of antibacterial agents such as beta-lactams or aminoglycosides. Ofloxacin has been shown to be active against most isolates of the following microorganisms, both in vitro and clinically in otic infections as described in the INDICATIONS AND USAGE section.

Aerobes, gram-positive: Staphylococcus aureus Streptococcus pneumoniae Aerobes, gram-negative: Escherichia coli Haemophilus influenzae Moraxella catarrhalis Proteus mirabilis Pseudomonas aeruginosa

📦 How Supplied / Storage and Handling 24 words ▾

HOW SUPPLIED Ofloxacin otic solution, 0.3% is supplied in plastic dropper bottles in the following sizes: NDC 24208-410-05 5 mL NDC 24208-410-10 10 mL

📋 Description 102 words ▾

DESCRIPTION Ofloxacin otic solution, 0.3% is a sterile aqueous anti-infective (antibacterial) solution for otic use. Chemically, ofloxacin has three condensed 6-membered rings made up of a fluorinated carboxyquinolone with a benzoxazine ring. The chemical name of ofloxacin is: (±)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo- 7H -pyrido [1,2,3- de ]-1,4-benzoxazine-6-carboxylic acid.

The empirical formula of ofloxacin is C 18 H 20 FN 3 O 4 and its molecular weight is 361.38. The structural formula is: Each mL contains: Active: ofloxacin 0.3% (3 mg/mL); Inactives: sodium chloride (0.9%), and purified water. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH 6.5±0.5.

Preservative: benzalkonium chloride (0.0025%). chem

💬 Information for Patients ~1 min read ▾

Information for Patients: Avoid contaminating the applicator tip with material from the fingers or other sources. This precaution is necessary if the sterility of the drops is to be preserved. Systemic quinolones, including ofloxacin, have been associated with hypersensitivity reactions, even following a single dose.

Discontinue use immediately and contact your physician at the first sign of a rash or allergic reaction. Otitis Externa: Prior to administration of ofloxacin otic, the solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness which may result from the instillation of a cold solution. The patient should lie with the affected ear upward, and then the drops should be instilled.

This position should be maintained for five minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear (see DOSAGE AND ADMINISTRATION ). Acute Otitis Media and Chronic Suppurative Otitis Media: Prior to administration of ofloxacin otic, the solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness which may result from the instillation of a cold solution.

The patient should lie with the affected ear upward, and then the drops should be instilled. The tragus should then be pumped 4 times by pushing inward to facilitate penetration of the drops into the middle ear. This position should be maintained for five minutes.

Repeat, if necessary, for the opposite ear (see DOSAGE AND ADMINISTRATION ).

🍼 Nursing Mothers 79 words ▾

Nursing Mothers: In nursing women, a single 200 mg oral dose resulted in concentrations of ofloxacin in milk which were similar to those found in plasma. It is not known whether ofloxacin is excreted in human milk following topical otic administration. Because of the potential for serious adverse reactions from ofloxacin 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.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 124 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies to determine the carcinogenic potential of ofloxacin have not been conducted. Ofloxacin was not mutagenic in the Ames test, the sister chromatid exchange assay (Chinese hamster and human cell lines), the unscheduled DNA synthesis (UDS) assay using human fibroblasts, the dominant lethal assay, or the mouse micronucleus assay. Ofloxacin was positive in the rat hepatocyte UDS assay, and in the mouse lymphoma assay.

In rats, ofloxacin did not affect male or female reproductive performance at oral doses up to 360 mg/kg/day. This would be over 1000 times the maximum recommended clinical dose, based upon body surface area, assuming total absorption of ofloxacin from the ear of a patient treated with ofloxacin otic solution, 0.3% twice per day.

📄 Package Label / Principal Display Panel 37 words ▾

Principal Display Panel – Ofloxacin Otic Solution 0.3% (Sterile) - 10 mL Carton NDC 24208-410-10 Ofloxacin Otic Solution 0.3% (Sterile) (ear icon) FOR USE IN EARS ONLY Rx only 10 mL BAUSCH + LOMB 9541202 AB41009 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.
📅 Q1 2025 – Q1 2026 · 5 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
6.2K
Units reimbursed last 4 qtrs
35.7K
Gross reimbursed last 4 qtrs
$122.6K
Avg / prescription
$19.62
Avg / unit
$3.4293
Latest quarter Q1 2026
1.4KRx
Medicaid pays / mL
$3.4293
gross reimbursed
vs
NADAC / mL
$1.1098
acquisition cost
=
Spread
+$2.3195
+209% vs cost
What Medicaid paid per mL (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 ⓘ
52% FFS 48% MCO
Fee-for-service · 3,277 Rx Managed care · 2,971 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 375 units · 4.8 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: 110 units · 14.0 per 100k residents ND Minnesota: 224 units · 3.9 per 100k residents MN Wisconsin: 435 units · 7.4 per 100k residents WI Michigan: 855 units · 8.5 per 100k residents MI New York: 14,245 units · 72.8 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 805 units · 19.0 per 100k residents OR Nevada: 60 units · 1.9 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 385 units · 12.0 per 100k residents IA Illinois: 235 units · 1.9 per 100k residents IL Indiana: 355 units · 5.2 per 100k residents IN Ohio: 305 units · 2.6 per 100k residents OH Pennsylvania: 692 units · 5.3 per 100k residents PA New Jersey: 925 units · 10.0 per 100k residents NJ Massachusetts: no data reported MA California: 2,531 units · 6.5 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 480 units · 7.7 per 100k residents MO Kentucky: 1,709 units · 37.8 per 100k residents KY West Virginia: 145 units · 8.2 per 100k residents WV Virginia: 459 units · 5.3 per 100k residents VA Maryland: 1,195 units · 19.3 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 195 units · 2.6 per 100k residents AZ New Mexico: no data reported NM Kansas: 150 units · 5.1 per 100k residents KS Arkansas: no data reported AR Tennessee: 273 units · 3.8 per 100k residents TN North Carolina: 235 units · 2.2 per 100k residents NC South Carolina: 155 units · 2.9 per 100k residents SC Delaware: no data reported DE Oklahoma: 110 units · 2.7 per 100k residents OK Louisiana: 940 units · 20.6 per 100k residents LA Mississippi: 1,175 units · 40.0 per 100k residents MS Alabama: 280 units · 5.5 per 100k residents AL Georgia: 1,970 units · 17.9 per 100k residents GA D.C.: 160 units · 23.6 per 100k residents DC Hawaii: 80 units · 5.6 per 100k residents HI Texas: 1,724 units · 5.7 per 100k residents TX Florida: 1,770 units · 7.8 per 100k residents FL
Units reimbursed · per 100k residents
1.972.8
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 New York 72.8 /100k
2 Mississippi 40.0 /100k
3 Kentucky 37.8 /100k
4 D.C. 23.6 /100k
5 Louisiana 20.6 /100k
6 Maryland 19.3 /100k
7 Oregon 19.0 /100k
8 Georgia 17.9 /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.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 bottle this page24208-0410-05 6,248 Rx · $122,563
1 bottle24208-0410-10 1,774 Rx · $47,889
Drug total (last 4 qtrs): 8,022 Rx · 53,178 units · $170,452 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Ofloxacin — the program that covers self-administered drugs. 15 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 Ofloxacin. 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
$5.52M
Claims incl. refills
354K
Beneficiaries
303.5K
Spend / beneficiary
$18.18
Spend / claim
$15.58
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.
← 24208-0399-15 · Bausch 24208-0411-05 · Bausch →
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.