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Ofloxacin Otic 3 mg/mL Solution, 10 mL — NDC 60505-0363-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Ofloxacin Otic 3 mg/mL Solution, 10 mL — NDC 60505-0363-2 (Billing 60505-0363-02)

by Apotex Corp. · 10 mL in 1 BOTTLE, DROPPER

This is a package of 10 mL of Ofloxacin Otic 3 mg/mL Solution from Apotex Corp., marketed since May 2004 and currently FDA-listed; retail pharmacies pay about $0.9790 per mL (NADAC).

NDC 60505-0363-02
🏷️ FDA NDC (as labeled) 60505-0363-2 billing pads the package segment with a zero
This package
Contains10 mL Cost per mL$0.9790 NADAC Per package$9.79 / 10 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $3.15/unit — full pricing hub ↓
Product page 60505-0363-01 Also comes in: 5 ml 60505-0363-1
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 60505-0363-2 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
60505 labeler · 0363 product · 2 package
Package marketed since
May 14, 2004
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
10 mL per package
Barcode (UPC-A, from the NDC)
3 6050503632 5
Medicaid fills, this package
60,787 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) 60505-0363-2
Product NDC 60505-0363
11-digit billing NDC 60505036302
NCPDP billing unit ML — per mL (volume)
Application # ANDA076527
SPL Set ID 8db221b1-32f3-f6ca-e404-71f56a860d08
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 2004-05-14
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

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
  • HICL (First Databank): 006035
  • AHFS class code: 08:12.18.00
Why two NDCs? The FDA registers this code as 60505-0363-2 — a 5-4-1 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 package segment → 60505-0363-02. 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 OFLOXACIN 0.3% EAR DROPS Ingredient Ofloxacin
📗 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 $0.979 $9.79 / 10 ml
Medicaid paysCMS SDUD · 12 mo $3.15 $31.54 / 10 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $2.435 $0.947
▼ Down 53% 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
60505-0363-01 60505-0363-1 Main listing 5 mL in 1 BOTTLE, DROPPER $1.11 / mL $5.55 2004-05-14 — Active
60505-0363-02 You're viewing this 10 mL in 1 BOTTLE, DROPPER $0.9790 / mL $9.79 2004-05-14 — Active

You're viewing the largest of 2 pack sizes for this product.

This pack has the lowest per-mL cost of the 2 priced pack sizes ($0.9790 NADAC).

This pack accounts for about 38% of this product's recent Medicaid fills; most go to the 5 ml pack. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 10 mL — 10 ml in 1 bottle, dropper.
How does this package differ from NDC 60505-0363-01?
Both are Ofloxacin Otic 3 mg/mL Solution — the drug itself is identical. This page's package is the 10 mL one, while NDC 60505-0363-01 is the 5 ml package. Per-mL NADAC also differs: $0.9790 here vs $1.11 for the 5 ml pack.
What NDC number is used to bill for this package of Ofloxacin Otic 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 Otic 3 mg/mLthis 60505-0363-02 Apotex 10 ml $0.979 AT Availability likely —
Ofloxacin 3 mg/mL 64980-0432-01 Rising 1 bottle $0.979 AT Availability likely —
Ofloxacin 3 mg/mL 65145-0144-01 Caplin 1 bottle $0.979 AT Availability likely —
Ofloxacin 3 mg/mL 69238-1616-06 Amneal 1 bottle $0.979 AT Availability likely —
Ofloxacin 3 mg/mL 70069-0687-01 Somerset 1 bottle $0.979 AT Availability likely —
ofloxacin 3 mg/mL 70756-0610-30 Lifestar 10 ml $0.979 AT Availability likely —
Ofloxacin 3 mg/mL 24208-0410-05 Bausch 1 bottle $1.110 AT Availability likely +13%
Ofloxacin 3 mg/mL 65145-0143-01 Caplin 1 bottle $1.110 AT Availability likely +13%
Ofloxacin 3 mg/mL 69238-1615-03 Amneal 1 bottle $1.110 AT Availability likely +13%
Ofloxacin 3 mg/mL 69315-0320-05 Leading 5 ml $1.110 AT Availability likely +13%
Ofloxacin 3 mg/mL 70069-0686-01 Somerset 1 bottle $1.110 AT Availability likely +13%
ofloxacin 3 mg/mL 70756-0609-15 Lifestar 5 ml $1.110 AT Availability likely +13%
ofloxacin 3 mg/mL 72603-0186-01 NorthStar 5 ml $1.110 AT Availability likely +13%
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

🏛️
2004
On the market since
May 2004
📍
2026
Currently FDA-listed
22 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.

  • 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

LabelerApotex Corp.
Application holderAPOTEX INC
FDA applicationANDA076527 (ANDA)
Labeler code60505
First marketedMay 2004
Product typeHuman Prescription Drug
Portfolio313 products on file

More NDCs from Apotex Corp. labeler code 60505

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 101 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 one 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 that 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 that 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.

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.

⛔ 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 Studies 002/003 (BID) and 016/017 (QD) were active-controlled and comparative. Study 020 (QD) was open and non-comparative. 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% 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 7% Earache 1% Pruritus 1% Paraesthesia 1% Rash 1% Dizziness 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%), 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 neurospsychiatric disturbances have been included in spontaneous post-marketing reports. A causal relationship with ofloxacin otic solution 0.3% is unknown.

🔄 Drug Interactions 14 words ▾

Drug Interactions Specific drug interaction studies have not been conducted with ofloxacin otic solution.

🤰 Pregnancy 185 words ▾

Pregnancy Teratogenic Effects Pregnancy Category C. Ofloxacin has been shown to have an embryocidal effect in rats at a dose of 810 mg/kg/day and in rabbits at 160 mg/kg/day. These dosages resulted in decreased fetal body weights and increased fetal mortality in rats and rabbits, respectively.

Minor fetal skeletal variations were reported in rats receiving doses of 810 mg/kg/day. Ofloxacin has not been shown to be teratogenic at doses as high as 810 mg/kg/day and 160 mg/kg/day when administered to pregnant rats and rabbits, respectively. Ofloxacin has not been shown to have any adverse effects on the developing embryo or fetus at doses relevant to the amount of ofloxacin that will be delivered ototopically at the recommended clinical doses.

Nonteratogenic Effects Additional studies in the rat demonstrated that doses up to 360 mg/kg/day during late gestation had no adverse effects on late fetal development, labor, delivery, lactation, neonatal viability, or growth of the newborn. There are, however, no adequate and well-controlled studies in pregnant women. Ofloxacin otic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 168 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 μg/g after otic administration of a 0.3% solution. Ofloxacin was present in high concentrations in otorrhea (389 - 2850 μg/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.

Aerobic and facultative gram-positive microorganisms: Staphylococcus aureus Streptococcus pneumoniae Aerobic and facultative gram-negative microorganisms: Escherichia coli Haemophilus influenzae Moraxella catarrhalis Proteus mirabilis Pseudomonas aeruginosa

📦 How Supplied / Storage and Handling 60 words ▾

HOW SUPPLIED Ofloxacin Otic Solution 0.3% is supplied in bottles containing 5 mL and 10 mL. The NDC codes are: 60505-0363-1 5 mL 60505-0363-2 10 mL Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature]. Protect from light. Manufactured by: Manufactured for: Apotex Inc. Apotex Corp. Toronto, Ontario Weston, FL Canada 33326 M9L 1T9 September 2018

📋 Description 104 words ▾

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

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: Ofloxacin Otic Solution contains 0.3% (3 mg/mL) ofloxacin with benzalkonium chloride (0.0025%), hydrochloric acid, sodium chloride, and water for injection. Additional hydrochloric acid and/or sodium hydroxide may be added to adjust the pH (6.5 ± 0.5).

💬 Information for Patients 62 words ▾

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.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General As with other anti-infective preparations, prolonged use may result in over-growth of nonsusceptible organisms, including fungi. If the infection is not improved after one week, cultures should be obtained to guide further treatment. If otorrhea persists after a full course of therapy, or if two or more episodes of otorrhea occur within six months, further evaluation is recommended to exclude an underlying condition such as cholesteatoma, foreign body, or a tumor.

The systemic administration of quinolones, including ofloxacin at doses much higher than given or absorbed by the otic route, has led to lesions or erosions of the cartilage in weight-bearing joints and other signs of arthropathy in immature animals of various species. Young growing guinea pigs dosed in the middle ear with 0.3% ofloxacin otic solution showed no systemic effects, lesions or erosions of the cartilage in weight-bearing joints, or other signs of arthropathy. No drug-related structural or functional changes of the cochlea and no lesions in the ossicles were noted in the guinea pig following otic administration of 0.3% ofloxacin for one month.

No signs of local irritation were found when 0.3% ofloxacin was applied topically in the rabbit eye. Ofloxacin was also shown to lack dermal sensitizing potential in the guinea pig maximization study. 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 solution, 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 solution, 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 ).

Drug Interactions Specific drug interaction studies have not been conducted with ofloxacin otic solution. 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 twice per day.

Pregnancy Teratogenic Effects Pregnancy Category C. Ofloxacin has been shown to have an embryocidal effect in rats at a dose of 810 mg/kg/day and in rabbits at 160 mg/kg/day. The… [Excerpted — this section continues on DailyMed.]

🍼 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 123 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 twice per day.

📄 Package Label / Principal Display Panel 62 words ▾

PRINCIPAL DISPLAY PANEL - 0.3% Bottle Label Representative sample of labeling (see HOW SUPPLIED section for complete listing): APOTEX CORP. NDC 60505-0363-1 Ofloxacin Otic Solution 0.3% Rx 5 mL Bottle Label

PRINCIPAL DISPLAY PANEL - 0.3% Carton Label Representative sample of labeling (see HOW SUPPLIED section for complete listing): APOTEX CORP. NDC 60505-0363-1 Ofloxacin Otic Solution 0.3% Rx 5 mL Carton Label

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
60.8K
Units reimbursed last 4 qtrs
620.8K
Gross reimbursed last 4 qtrs
$1.96M
Avg / prescription
$32.22
Avg / unit
$3.1542
Latest quarter Q1 2026
6.4KRx
Medicaid pays / mL
$3.1542
gross reimbursed
vs
NADAC / mL
$0.9790
acquisition cost
=
Spread
+$2.1752
+222% 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 ⓘ
34% FFS 66% MCO
Fee-for-service · 20,555 Rx Managed care · 40,232 Rx
State Medicaid map
Alaska: no data reported AK Maine: 380 units · 27.2 per 100k residents ME Washington: 4,400 units · 56.3 per 100k residents WA Idaho: 140 units · 7.1 per 100k residents ID Montana: 231 units · 20.4 per 100k residents MT North Dakota: 640 units · 81.7 per 100k residents ND Minnesota: 2,675 units · 46.6 per 100k residents MN Wisconsin: 2,690 units · 45.5 per 100k residents WI Michigan: 11,080 units · 110 per 100k residents MI New York: 53,450 units · 273 per 100k residents NY Vermont: 120 units · 18.5 per 100k residents VT New Hampshire: no data reported NH Oregon: 1,735 units · 41.0 per 100k residents OR Nevada: 7,705 units · 241 per 100k residents NV Wyoming: no data reported WY South Dakota: 355 units · 38.6 per 100k residents SD Iowa: 4,535 units · 141 per 100k residents IA Illinois: 7,375 units · 58.8 per 100k residents IL Indiana: 28,730 units · 419 per 100k residents IN Ohio: 24,360 units · 207 per 100k residents OH Pennsylvania: 75,114 units · 580 per 100k residents PA New Jersey: 9,163 units · 98.6 per 100k residents NJ Massachusetts: 1,711 units · 24.4 per 100k residents MA California: 118,491 units · 304 per 100k residents CA Utah: 180 units · 5.3 per 100k residents UT Colorado: 940 units · 16.0 per 100k residents CO Nebraska: 860 units · 43.5 per 100k residents NE Missouri: 8,150 units · 132 per 100k residents MO Kentucky: 8,400 units · 186 per 100k residents KY West Virginia: 5,500 units · 311 per 100k residents WV Virginia: 2,930 units · 33.6 per 100k residents VA Maryland: 16,594 units · 269 per 100k residents MD Connecticut: 1,230 units · 34.0 per 100k residents CT Rhode Island: no data reported RI Arizona: 13,485 units · 181 per 100k residents AZ New Mexico: 150 units · 7.1 per 100k residents NM Kansas: 410 units · 13.9 per 100k residents KS Arkansas: 430 units · 14.0 per 100k residents AR Tennessee: 1,640 units · 23.0 per 100k residents TN North Carolina: 990 units · 9.1 per 100k residents NC South Carolina: 700 units · 13.0 per 100k residents SC Delaware: 2,600 units · 252 per 100k residents DE Oklahoma: 5,820 units · 144 per 100k residents OK Louisiana: 7,990 units · 175 per 100k residents LA Mississippi: 5,342 units · 182 per 100k residents MS Alabama: 6,825 units · 134 per 100k residents AL Georgia: 4,725 units · 42.8 per 100k residents GA D.C.: 450 units · 66.3 per 100k residents DC Hawaii: 9,060 units · 631 per 100k residents HI Texas: 47,520 units · 156 per 100k residents TX Florida: 112,845 units · 499 per 100k residents FL
Units reimbursed · per 100k residents
5.3631
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 Hawaii 631 /100k
2 Pennsylvania 580 /100k
3 Florida 499 /100k
4 Indiana 419 /100k
5 West Virginia 311 /100k
6 California 304 /100k
7 New York 273 /100k
8 Maryland 269 /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.
5 ml60505-0363-01 100,941 Rx · $1,941,145
10 ml this page60505-0363-02 60,787 Rx · $1,958,263
Drug total (last 4 qtrs): 161,728 Rx · 1,168,872 units · $3,899,409 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 (matched by generic name) — 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. CMS lists 2 products for this generic; we show the highest-spend one. 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.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Ofloxacin — the ingredient across all brands.

Top reported reactions

Eye Pain348
Headache289
Pain280
Fatigue272
Nausea260
Arthralgia256
Diarrhoea250

Reporter sex

0 reports

Serious outcomes

Death608
Disabling375
Life-threatening356
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 680 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
← 60505-0258-01 · Apotex 60505-0404-05 · Apotex →
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.