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Ofloxacin 3 mg/mL Solution — NDC 69238-1616-06 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Ofloxacin 3 mg/mL Solution — NDC 69238-1616-6 (Billing 69238-1616-06)

by Amneal Pharmaceuticals NY LLC · 1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER

This is a package of Ofloxacin 3 mg/mL Solution from Amneal Pharmaceuticals NY LLC, marketed since Aug 2019 and currently FDA-listed; retail pharmacies pay about $0.9790 per mL (NADAC). It is this product's only package size.

NDC 69238-1616-06
🏷️ FDA NDC (as labeled) 69238-1616-6 billing pads the package 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 →

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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 69238-1616-6 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
69238 labeler · 1616 product · 6 package
Package marketed since
Aug 30, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 6923816166 3
Medicaid fills, this package
52,007 prescriptions in the last four reported quarters
FDA record last changed
Oct 8, 2026
Past resolved recalls for this product (1)
Class II · Apr 13, 2022 · Terminated — cGMP deviations: Temperature abuse (Mckesson Medical-Surgical Inc. Corporate Office) · FDA recall D-1114-2022

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69238-1616-6
Product NDC 69238-1616
11-digit billing NDC 69238161606
NCPDP billing unit ML — per mL (volume)
RxCUI 242446
UNII A4P49JAZ9H
Application # ANDA211525
SPL Set ID ba37e2a0-1bf7-41ca-bddd-35fcb77f87de
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 2019-08-30
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 69238-1616-6 — 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 → 69238-1616-06. 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
📗 Our plain-language guide HelloPharmacist
  • It treats certain bacterial ear infections. These include outer ear infection, a long-lasting middle ear infection with a hole in the eardrum, and a sudden middle ear infection in...
  • Hold the bottle in your hand for a minute or two to warm it, since cold drops can make you dizzy. Lie with the sore ear up, add the drops, and stay there for five minutes. For midd...
  • Some people notice itching, mild irritation, earache, dizziness, or headache. A funny taste can happen, especially if there is a hole in the eardrum or ear tubes. These are usually...
  • Stop the drops and get help right away if you have trouble breathing, swelling of the face or throat, hives, widespread itching, or feel faint. These can be signs of a serious alle...
📖 Read our full Ofloxacin Otic guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 $2.48 $24.76 / 10 ml
Medicare drug plans payPart D · Q2 2026 $2.37 $23.67 / 10 ml
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 Marketing startMarketing endStatus
69238-1616-06 You're viewing this Main listing 1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER 2019-08-30 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
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/mLthis 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 Otic 3 mg/mL 60505-0363-01 Apotex 5 ml $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 85766-0226-05 Sportpharm 5 ml — AT FDA listed —
ofloxacin 3 mg/mL 85766-0227-10 Sportpharm 10 ml — AT FDA listed —
ofloxacin 3 mg/mL 70518-4147-00 REMEDYREPACK 10 ml — 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

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

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Ofloxacin Otic 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

LabelerAmneal Pharmaceuticals NY LLC
Application holderAMNEAL EU LTD
FDA applicationANDA211525 (ANDA)
Labeler code69238
First marketedAug 2019
Product typeHuman Prescription Drug
Portfolio372 products on file

More NDCs from Amneal Pharmaceuticals NY LLC labeler code 69238

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 ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 100 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 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.

⛔ 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.

Adverse Event Incidence Rate 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 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 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 Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 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 mcg/g to 602 mcg/g after otic administration of a 0.3% solution. Ofloxacin was present in high concentrations in otorrhea (389 mcg/g to 2,850 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.

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 110 words ▾

HOW SUPPLIED Ofloxacin Otic Solution is a clear pale yellow to yellow color solution and is supplied in 5 mL and 10 mL LDPE white opaque bottle with LDPE white opaque nozzle and HDPE white opaque cap. Each mL contains ofloxacin USP, 0.3% (3 mg/mL). It is available as follows: 5 mL in 5 mL Container: NDC 69238-1615-3 10 mL in 10 mL Container: NDC 69238-1616-6 Store at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°F) .

Protect from light. Keep out of reach of children. Manufactured by: Amneal Pharmaceuticals Pvt.

Ltd. Parenteral Unit Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 10-2020-02

📋 Description 148 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 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 molecular formula of ofloxacin is C 18 H 20 FN 3 O 4 and its molecular weight is 361.37. The structural formula is: Ofloxacin, USP is white to off-white or pale yellow crystalline powder. It is soluble in glacial acetic acid; sparingly soluble in chloroform and in 0.1N sodium hydroxide; sparingly soluble to slightly soluble in methylene chloride; slightly soluble in dimethylformamide and very slightly soluble in methyl alcohol and water.

Ofloxacin otic solution contains 0.3% (3 mg/mL) ofloxacin, USP with benzalkonium chloride (0.0025%), sodium chloride (0.9%), and water for injection. Hydrochloric acid and sodium hydroxide are added to adjust the pH between 6.0 and 7.0. 10

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General As with other anti-infective preparations, prolonged use may result in over-growth of non-susceptible 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 1,000 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. Th… [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.

🧬 Pharmacokinetics 196 words ▾

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 mcg/g to 602 mcg/g after otic administration of a 0.3% solution. Ofloxacin was present in high concentrations in otorrhea (389 mcg/g to 2,850 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.

📄 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 1,000 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.

📄 Patient Package Insert ~3 min read ▾

Patient Information Ofloxacin ( oh flox’ a sin ) Otic Solution (0.3%) IMPORTANT PATIENT INFORMATION AND INSTRUCTIONS. READ BEFORE USE. What is ofloxacin otic solution?

Ofloxacin otic solution is an antibiotic in a sterile solution used to treat ear infections caused by certain bacteria found in: patients (12 years and older) who have a middle ear infection and have a hole in the eardrum pediatric patients (between 1 and 12 years of age) who have a middle ear infection and have a tube in the eardrum patients (6 months and older) who have an infection in the ear canal. Middle ear infection A middle ear infection is a bacterial infection behind the eardrum. People with a hole or a tube in the eardrum may notice a discharge (fluid draining) from the ear canal.

Ear canal infection An ear canal infection (also known as “Swimmer’s Ear”) is a bacterial infection of the ear canal. The ear canal and the outer part of the ear may swell, turn red, and be painful. Also, a fluid discharge may appear in the ear canal.

Who should NOT use ofloxacin otic solution? Do not use this product if you are allergic to ofloxacin or to other quinolone antibiotics. Do not give this product to pediatric patients who: have an ear canal infection and are less than 6 months of age because no data were collected from this population have a middle ear infection and have a tube in the eardrum and are less than one year of age because no data were collected from this population have a middle ear infection and have a hole in the eardrum and are less than 12 years of age because no data were collected from this population How should ofloxacin otic solution be given?

1. Wash hands The person giving ofloxacin otic solution should wash his/her hands with soap and water. 2.

Clean ear & warm bottle Gently clean any discharge that can be removed easily from the outer ear. DO NOT INSERT ANY OBJECT OR SWAB INTO THE EAR CANAL. Hold the bottle of ofloxacin otic solution in the hand for one or two minutes to warm the solution.

3. Add drops For a Middle Ear Infection: The person receiving ofloxacin otic solution should lie on his/her side with the infected ear up. Patients (12 and older) should have 10 drops of ofloxacin otic solution put into the infected ear.

Pediatric patients under 12 should have 5 drops put into the infected ear. The tip of the bottle should not touch the fingers or the ear or any other surfaces. For an Ear Canal Infection (“Swimmer’s Ear”): The person receiving ofloxacin otic solution should lie on his/her side with the infected ear up.

Patients (13 and older) should have 10 drops of ofloxacin otic solution put into the infected ear. Pediatric patients under 13 should have 5 drops put into the infected ear. The tip of the bottle should not touch the fingers or the ear or any other surfaces.

BE SURE TO FOLLOW THE INSTRUCTIONS BELOW FOR THE PATIENT’S SPECIFIC EAR INFECTION. 4. Press ear or pull ear For a Middle Ear Infection: While the person receiving ofloxacin otic solution lies on his/her side, the person giving the drops should gently press the TRAGUS (see diagram) 4 times in a pumping motion.

This will allow the drops to pass through the hole or tube in the eardrum and into the middle ear. For an Ear Canal Infection (“Swimmer’s Ear”): While the person receiving the drops lies on his/her side, the person giving the drops should gently pull the outer ear upward and backward. This will allow the ear drops to flow down into the ear canal.

5. Stay on side The person who received the ear drops should remain on his/her side for at least 5 minutes. Repeat Steps 2 to 5 for the other ear if both ears are infected.

How often should ofloxacin otic solution be given? In patients with an Ear Canal Infection (“Swimmer’s Ear”), ofloxacin otic solution ear drops should be given once daily at about the same time each day (for example, 8 AM or 8 PM) in each infected ear unless the doctor has instructed otherwise. In patients with a Middle Ear Infection, ofloxacin otic s… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 33 words ▾

PRINCIPAL DISPLAY PANEL NDC 69238-1616-6 Ofloxacin Otic Solution, 0.3% (10 mL) Rx Only Amneal Pharmaceuticals LLC NDC 69238-1615-3 Ofloxacin Otic Solution, 0.3% (5 mL) Rx Only Amneal Pharmaceuticals LLC df 1 er 1

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
52K
Units reimbursed last 4 qtrs
520.3K
Gross reimbursed last 4 qtrs
$1.29M
Avg / prescription
$24.77
Avg / unit
$2.4758
Latest quarter Q1 2026
11.8KRx
Medicaid pays / mL
$2.4758
gross reimbursed
vs
NADAC / mL
$0.9790
acquisition cost
=
Spread
+$1.4968
+153% 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 ⓘ
46% FFS 54% MCO
Fee-for-service · 23,914 Rx Managed care · 28,093 Rx
State Medicaid map
Alaska: 210 units · 28.6 per 100k residents AK Maine: 2,620 units · 188 per 100k residents ME Washington: 5,790 units · 74.1 per 100k residents WA Idaho: 1,490 units · 75.9 per 100k residents ID Montana: 260 units · 23.0 per 100k residents MT North Dakota: 420 units · 53.6 per 100k residents ND Minnesota: 8,620 units · 150 per 100k residents MN Wisconsin: 12,125 units · 205 per 100k residents WI Michigan: 15,700 units · 156 per 100k residents MI New York: 22,263 units · 114 per 100k residents NY Vermont: 2,035 units · 315 per 100k residents VT New Hampshire: 620 units · 44.2 per 100k residents NH Oregon: 7,670 units · 181 per 100k residents OR Nevada: 4,380 units · 137 per 100k residents NV Wyoming: no data reported WY South Dakota: 840 units · 91.4 per 100k residents SD Iowa: 8,885 units · 277 per 100k residents IA Illinois: 19,215 units · 153 per 100k residents IL Indiana: 9,515 units · 139 per 100k residents IN Ohio: 14,940 units · 127 per 100k residents OH Pennsylvania: 11,140 units · 86.0 per 100k residents PA New Jersey: 1,434 units · 15.4 per 100k residents NJ Massachusetts: 4,738 units · 67.7 per 100k residents MA California: 122,263 units · 314 per 100k residents CA Utah: 1,730 units · 50.6 per 100k residents UT Colorado: 7,620 units · 130 per 100k residents CO Nebraska: 2,330 units · 118 per 100k residents NE Missouri: 16,180 units · 261 per 100k residents MO Kentucky: 20,220 units · 447 per 100k residents KY West Virginia: 5,150 units · 291 per 100k residents WV Virginia: 3,145 units · 36.1 per 100k residents VA Maryland: 5,515 units · 89.2 per 100k residents MD Connecticut: 4,340 units · 120 per 100k residents CT Rhode Island: 2,650 units · 242 per 100k residents RI Arizona: 10,155 units · 137 per 100k residents AZ New Mexico: 10,460 units · 495 per 100k residents NM Kansas: 1,500 units · 51.0 per 100k residents KS Arkansas: 1,760 units · 57.4 per 100k residents AR Tennessee: 17,950 units · 252 per 100k residents TN North Carolina: 11,335 units · 105 per 100k residents NC South Carolina: 3,610 units · 67.2 per 100k residents SC Delaware: 4,920 units · 477 per 100k residents DE Oklahoma: 10,715 units · 264 per 100k residents OK Louisiana: 16,720 units · 366 per 100k residents LA Mississippi: 10,051 units · 342 per 100k residents MS Alabama: 9,400 units · 184 per 100k residents AL Georgia: 5,425 units · 49.2 per 100k residents GA D.C.: 365 units · 53.8 per 100k residents DC Hawaii: 740 units · 51.6 per 100k residents HI Texas: 36,925 units · 121 per 100k residents TX Florida: 22,260 units · 98.5 per 100k residents FL
Units reimbursed · per 100k residents
15.4495
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 Mexico 495 /100k
2 Delaware 477 /100k
3 Kentucky 447 /100k
4 Louisiana 366 /100k
5 Mississippi 342 /100k
6 Vermont 315 /100k
7 California 314 /100k
8 West Virginia 291 /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 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.
← 69238-1615-03 · Amneal 69238-1621-01 · Amneal →
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.