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Ofloxacin 3 mg/mL Solution — NDC 63187-734-05 (Billing 63187-0734-05)

by Proficient Rx LP · 1 BOTTLE, PLASTIC in 1 CARTON / 5 mL in 1 BOTTLE, PLASTIC

This is a package of Ofloxacin 3 mg/mL Solution from Proficient Rx LP, marketed since Dec 2014 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 63187-0734-05
🏷️ FDA NDC (as labeled) 63187-734-05 billing pads the product segment with a zero
This package
Contains5 mL in 1 bottle, plastic Pack sizes2 compare ↓
Also priced by: Part D plans $1.98/unit — full pricing hub ↓
Main listing for product 63187-734 · Also comes in: 10 mL 63187-734-10
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 63187-734-05 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
63187 labeler · 734 product · 05 package
Package marketed since
Jul 1, 2016
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 6318773405 3
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63187-734-05
Product NDC 63187-734
11-digit billing NDC 63187073405
NCPDP billing unit ML — per mL (volume)
RxCUI 312075
UNII A4P49JAZ9H
Application # ANDA078559
SPL Set ID a2089612-de4b-4d78-b311-fa2524bd37f6
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 2014-12-15
Route OPHTHALMIC
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 86101047002020
GPI class Ofloxacin
GCN Seq No 019734
GCN 36600
HICL code 006035
Ingredient (HICL) Ofloxacin
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q6
Therapeutic class — intermediate (HIC2) Ophthalmic Preparations
HIC3 code Q6W
Therapeutic class — specific (HIC3) Ophthalmic Antibiotics
AHFS code 08:12.18.00
AHFS class Quinolone Antibiotics
FDB label name OFLOXACIN 0.3% EYE DROPS
FDB brand name Ofloxacin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 019734
  • GCN: 36600
  • GPI-14 (Medi-Span): 86101047002020
  • HICL (First Databank): 006035
  • AHFS class code: 08:12.18.00
  • RxCUI (RxNorm): 312075
Why two NDCs? The FDA registers this code as 63187-734-05 — 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 → 63187-0734-05. 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% EYE 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 Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $1.98 $9.88 / 5 ml
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
63187-0734-05 You're viewing this Main listing 1 BOTTLE, PLASTIC in 1 CARTON / 5 mL in 1 BOTTLE, PLASTIC 2016-07-01 — Active
63187-0734-10 63187-734-10 1 BOTTLE, PLASTIC in 1 CARTON / 10 mL in 1 BOTTLE, PLASTIC 2016-07-01 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle, plastic in 1 carton / 5 ml in 1 bottle, plastic.
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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ofloxacin 3 mg/mL 64980-0515-01 Rising 1 bottle $1.114 AT Availability likely —
Ofloxacin 3 mg/mL 65145-0142-01 Caplin 10 ml $1.114 AT Availability likely —
ofloxacin 3 mg/mL 70756-0650-30 Lifestar 1 bottle $1.114 AT Availability likely —
ofloxacin 3 mg/mL 00904-7434-05 Major 1 bottle $1.241 AT Availability likely —
Ofloxacin 3 mg/mL 24208-0434-05 Bausch 1 bottle $1.241 AT Availability likely —
Ofloxacin 3 mg/mL 60505-0560-00 Apotex 1 bottle $1.241 AT Availability likely —
Ofloxacin 3 mg/mL 65145-0141-01 Caplin 5 ml $1.241 AT Availability likely —
Ofloxacin 3 mg/mL 69315-0327-05 Leading 5 ml $1.241 AT Availability likely —
Ofloxacin 3 mg/mL 70069-0411-01 Somerset 1 bottle $1.241 AT Availability likely —
Ofloxacin 3 mg/mL 70512-0793-05 SOLA 1 bottle $1.241 AT Availability likely —
ofloxacin 3 mg/mL 70756-0607-30 Lifestar 1 bottle $1.241 AT Availability likely —
Ofloxacin 3 mg/mL 72485-0613-10 ARMAS 1 bottle $1.241 AT Availability likely —
ofloxacin 3 mg/mL 72603-0192-01 NorthStar 5 ml $1.241 AT Availability likely —
Ocuflox 3 mg/mL 11980-0779-05 Allergan, 1 bottle — AT FDA listed —
Ofloxacin 3 mg/mL 50090-1744-00 A-S 1 bottle — AT FDA listed —
Ofloxacin 3 mg/mL 50090-5186-00 A-S 1 bottle — AT FDA listed —
Ofloxacin 3 mg/mL 50090-5209-00 A-S 1 bottle — AT FDA listed —
Ofloxacin 3 mg/mL 50090-5425-00 A-S 1 bottle — AT FDA listed —
ofloxacin 3 mg/mL 50090-6794-00 A-S 1 bottle — AT FDA listed —
Ofloxacin 3 mg/mL 50090-7264-00 A-S 1 bottle — AT FDA listed —
ofloxacin 3 mg/mL 50090-7761-00 A-S 5 ml — AT FDA listed —
Ofloxacin ophthalmic 3 mg/mL 59390-0140-05 Altaire 5 ml — AT FDA listed —
Ofloxacin 3 mg/mL 60760-0917-05 St. 1 bottle — AT FDA listed —
Ofloxacin 3 mg/mL 60760-0970-05 ST. 1 bottle — AT FDA listed —
Ofloxacin 3 mg/mL 63187-0268-05 Proficient 1 bottle — AT FDA listed —
Ofloxacin 3 mg/mL 63187-0662-05 Proficient 1 bottle — AT FDA listed —
Ofloxacin 3 mg/mLthis 63187-0734-05 Proficient 1 bottle — AT FDA listed —
Ofloxacin 3 mg/mL 68071-1607-05 NuCare 5 ml — AT FDA listed —
Ofloxacin 3 mg/mL 68071-2254-05 NuCare 1 bottle — AT FDA listed —
Ofloxacin 3 mg/mL 68071-2265-01 NuCare 1 bottle — AT FDA listed —
ofloxacin 3 mg/mL 68071-3448-05 NuCare 1 bottle — AT FDA listed —
Ofloxacin 3 mg/mL 68071-3566-01 NuCare 1 bottle — AT FDA listed —
ofloxacin 3 mg/mL 68071-3919-05 NuCare 5 ml — AT FDA listed —
Ofloxacin 3 mg/mL 68788-7693-05 Preferred 1 bottle — AT FDA listed —
ofloxacin 3 mg/mL 68788-8449-05 Preferred 1 bottle — AT FDA listed —
Ofloxacin 3 mg/mL 68788-8761-05 Preferred 1 bottle — AT FDA listed —
ofloxacin 3 mg/mL 70518-3710-00 REMEDYREPACK 1 bottle — AT FDA listed —
Ofloxacin 3 mg/mL 71205-0420-05 Proficient 1 bottle — AT FDA listed —
Ofloxacin Ophth Soln 3 mg/mL 72189-0472-05 Direct_Rx 5 ml — AT FDA listed —
ofloxacin 3 mg/mL 82804-0101-05 Proficient 1 bottle — AT FDA listed —
Ofloxacin 3 mg/mL 70518-3573-00 REMEDYREPACK 1 bottle — AT Discontinued —
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

🏛️
2014
On the market since
Dec 2014
📍
2026
Currently FDA-listed
12 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.

  • 0.05 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.

4 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

LabelerProficient Rx LP
Application holderFDC LTD
FDA applicationANDA078559 (ANDA)
Labeler code63187
First marketedDec 2014
Product typeHuman Prescription Drug
Portfolio1,729 products on file

More NDCs from Proficient Rx LP labeler code 63187

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 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🧬 Pharmacokinetics 🔬 Clinical Studies 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 77 words ▾

INDICATIONS AND USAGE Ofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below: CONJUNCTIVITIS: Gram-positive bacteria: Gram-negative bacteria: Staphylococcus aureus Enterobacter cloacae Staphylococcus epidermidis Haemophilus influenzae Streptococcus pneumoniae Proteus mirabilis Pseudomonas aeruginosa CORNEAL ULCERS: Gram-positive bacteria: Gram-negative bacteria: Staphylococcus aureus Pseudomonas aeruginosa Staphylococcus epidermidis Serratia marcescens* Streptococcus pneumoniae Anaerobic species: Propionibacterium acnes * Efficacy for this organism was studied in fewer than 10 infections

⏱️ Dosage and Administration 117 words ▾

DOSAGE AND ADMINISTRATION The recommended dosage regimen for the treatment of bacterial conjunctivitis is: Days 1 and 2 Instill one to two drops every two to four hours in the affected eye(s). Days 3 through 7 Instill one to two drops four times daily. The recommended dosage regimen for the treatment of bacterial corneal ulcer is: Days 1 and 2 Instill one to two drops into the affected eye every 30 minutes, while awake.

Awaken at approximately four and six hours after retiring and instill one to two drops. Days 3 through 7 to 9 Instill one to two drops hourly, while awake. Days 7 to 9 throughtreatment completion Instill one to two drops, four times daily.

⛔ Contraindications 27 words ▾

CONTRAINDICATIONS Ofloxacin Ophthalmic Solution is contraindicated in patients with a history of hypersensitivity to ofloxacin, to other quinolones, or to any of the components in this medication.

⚠️ Warnings 125 words ▾

WARNINGS NOT FOR INJECTION. Ofloxacin ophthalmic solution should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye. 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. A rare occurrence of Stevens-Johnson syndrome, which progressed to toxic epidermal necrolysis, has been reported in a patient who was receiving topical ophthalmic ofloxacin. If an allergic reaction to ofloxacin occurs, discontinue 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 65 words ▾

ADVERSE REACTIONS Ophthalmic Use: The most frequently reported drug-related adverse reaction was transient ocular burning or discomfort. Other reported reactions include stinging, redness, itching, chemical conjunctivitis/keratitis, ocular/periocular/facial edema, foreign body sensation, photophobia, blurred vision, tearing, dryness, and eye pain. Rare reports of dizziness and nausea have been reported.

To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharmaceuticals, Inc. at 866-562-4597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Pharmacokinetics: Serum, urine and tear concentrations of ofloxacin were measured in 30 healthy women at various time points during a ten-day course of treatment with ofloxacin ophthalmic solution. The mean serum ofloxacin concentration ranged from 0.4 ng/mL to 1.9 ng/mL. Maximum ofloxacin concentration increased from 1.1 ng/mL on day one to 1.9 ng/mL on day 11 after QID dosing for 10 1/2 days.

Maximum serum ofloxacin concentrations after ten days of topical ophthalmic dosing were more than 1000 times lower than those reported after standard oral doses of ofloxacin. Tear ofloxacin concentrations ranged from 5.7 to 31 mcg/g during the 40 minute period following the last dose on day 11. Mean tear concentration measured four hours after topical ophthalmic dosing was 9.2 mcg/g.

Corneal tissue concentrations of 4.4 mcg/mL were observed four hours after beginning topical ocular application of two drops of ofloxacin ophthalmic solution every 30 minutes. Ofloxacin was excreted in the urine primarily unmodified. Microbiology: Ofloxacin has in vitro activity against a broad range of gram-positive and gram-negative aerobic and anaerobic bacteria.

Ofloxacin is bactericidal at concentrations equal to or slightly greater than inhibitory concentrations. Ofloxacin is thought to exert a bactericidal effect on susceptible bacterial cells by inhibiting DNA gyrase, an essential bacterial enzyme which is a critical catalyst in the duplication, transcription, and repair of bacterial DNA. 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 strains of the following organisms both in vitro and clinically, in conjunctival and/or corneal ulcer infections as described in the INDICATIONS AND USAGE section. AEROBES, GRAM-POSITIVE: AEROBES, GRAM-NEGATIVE: Staphylococcus aureus Enterobacter cloacae Staphylococcus epidermidis Haemophilus influenza Streptococcus pneumoniae Proteus mirabilis ANAEROBIC SPECIES: Pseudomonas aeruginosa Propionibacterium acnes Serratia marcescens* *Efficasy for this organism was studied in fewer than 10 infection The safety and effectiveness of ofloxacin ophthalmic solution in treating ophthalmologic infections due to the following organisms have not been established in adequate and well-controlled clinical trials.

Ofloxacin ophthalmic solution has been shown to be active in vitro against most strains of these organisms but the clinical significance in ophthalmologic infections is unknown. AEROBES, GRAM-POSITIVE: Enterococcus faecalis Staphylococcus hominus Listeria monocytogenes Staphylococcus simulans Staphylococcus capitis Streptococcus pyogenes AEROBES, GRAM-NEGATIVE: Acinetobacter calcoaceticus var. anitratus Klebsiella pneumoniae Acinetobacter calcoaceticus var. lwoffii Moraxella (Branhamella) catarrhalis Citrobacter diversus Moraxella lacunata Citrobacter freundii Morganella morganii Enterobacter aerogenes Neisseria gonorrhoeae Enterobacter agglomerans Pseudomonas acidovorans Escherichia coli Pseudomonas fluorescens Haemophilus parainfluenzae Shigella sonnei Klebsiella oxytoca OTHER: Chlamydia trachomatis Clinical Studies: Conjunctivitis: In a randomized, double-masked, multicenter clinical trial, ofloxacin ophthalmic solution was superior to its vehicle after 2 days of treatment in patients with conjunctivitis and positive conjunctival cultures.

Clinical outcomes for the trial demonstrated a clinical improvement rate of 86% (54/63) for the ofloxacin treated group versus 72% (48/67) for the placebo treated group after 2 days of therapy. Microbiological outcomes for the same clinical trial demonstrated an eradication rate for causative pathogens of 65% (41/63) for the ofloxacin treated group versus 25% (17/67) for the vehicle treated group after 2 days of therapy. Please note that microbi… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling ~2 min read ▾

HOW SUPPLIED Ofloxacin Ophthalmic Solution 0.3% is supplied sterile in a translucent LDPE bottle with insert cap assembly comprising of tan colored HDPE screw cap over a LDPE nozzle with tamper evident LDPE dust cover sealing the bottle cap. 5 mL in 5 mL bottle NDC 63187-734-05 10 mL in 10 mL bottle NDC 63187-734-10 Note: Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature]. Rx Only W10WLL01AESRP Manufactured for: Rising Pharmaceuticals, Inc Allendale, NJ 07401 MADE IN INDIA Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 Revision 12/14 INSTRUCTIONS FOR USE Please follow these instructions carefully when using Ofloxacin Ophthalmic Solution.

Use Ofloxacin ophthalmic solution as prescribed by your doctor. 1. If you use other topically applied ophthalmic medications, they should be administered at least 10 minutes before or after the use of Ofloxacin ophthalmic solution.

2. Wash hands before each use. 3.

Before using the medication for the first time, be sure the dust cover seal is unbroken. 4. Refer (I-VI) Image Image Image Image Image Image 5.

OPHTHALMIC MEDICATIONS, IF HANDLED IMPROPERLY, CAN BECOME CONTAMINATED BY COMMON BACTERIA KNOWN TO CAUSE EYE INFECTIONS. SERIOUS DAMAGE TO THE EYE AND SUBSEQUENT LOSS OF VISION MAY RESULT FROM USING CONTAMINATED OPHTHALMIC MEDICATIONS. IF YOU THINK YOUR MEDICATION MAY BE CONTAMINATED, OR IF YOU DEVELOP AN EYE INFECTION, CONTACT YOUR DOCTOR IMMEDIATELY CONCERNING CONTINUED USE OF THIS BOTTLE.

6. Repeat (V) and (VI) with the other eye if instructed to do by your doctor. 7.

The insert tip is designed to provide a premeasured drop; therefore, do NOT enlarge the hole of the insert tip. 8. After you have used all doses, there will be some Ofloxacin Ophthalmic Solution left in the bottle.

You should not be concerned since an extra amount of Ofloxacin Ophthalmic Solution has been added and you will get the full amount of Ofloxacin Ophthalmic Solution that your doctor prescribed. Do not attempt to remove excess medicine from the bottle. WARNING: KEEP OUT OF REACH OF CHILDREN.

IF YOU HAVE ANY QUESTIONS ABOUT THE USE OF OFLOXACIN OPHTHALMIC SOLUTION, PLEASE CONSULT YOUR DOCTOR. Image 1 Image 2 Image 3 Image 4 Image 5 Image 6

📋 Description 110 words ▾

DESCRIPTION Ofloxacin ophthalmic solution 0.3% is a sterile ophthalmic solution. It is a fluorinated carboxyquinolone anti-infective for topical ophthalmic use. Chemical Name: (±)-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.

Contains: Active: ofloxacin 0.3% (3 mg/mL) Preservative: benzalkonium chloride (0.005%) Inactives: sodium chloride and water for injection. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH. Ofloxacin ophthalmic solution is unbuffered and formulated with a pH of 6.4 (range 6.0 to 6.8).

It has an osmolality of 300 mOsm/kg. Ofloxacin is a fluorinated 4-quinolone which differs from other fluorinated 4-quinolones in that there is a six member (pyridobenzoxazine) ring from positions 1 to 8 of the basic ring structure. Image Structure

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General: As with other anti-infectives, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs discontinue use and institute alternative therapy. Whenever clinical judgement dictates, the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.

Ofloxacin should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity reaction. The systemic administration of quinolones, including ofloxacin, has led to lesions or erosions of the cartilage in weight-bearing joints and other signs of arthropathy in immature animals of various species. Ofloxacin, administered systemically at 10 mg/kg/day in young dogs (equivalent to 110 times the maximum recommended daily adult ophthalmic dose) has been associated with these types of effects.

Information for Patients: Avoid contaminating the applicator tip with material from the eye, fingers or other source. 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.

Drug Interactions: Specific drug interaction studies have not been conducted with ofloxacin ophthalmic solution. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, and enhance the effects of the oral anticoagulant warfarin and its derivatives, and has been associated with transient elevations in serum creatinine in patients receiving cyclosporine concomitantly. 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, in vitro and in vivo cytogenic assay, sister chromatid exchange assay (Chinese hamster and human cell lines), unscheduled DNA synthesis (UDS) assay using human fibroblasts, the dominant lethal assay, or mouse micronucleus assay. Ofloxacin was positive in the UDS test using rat hepatocyte, and in the mouse lymphoma assay. In fertility studies in rats, ofloxacin did not affect male or female fertility or morphological or reproductive performance at oral dosing up to 360 mg/kg/day (equivalent to 4000 times the maximum recommended daily ophthalmic dose).

Pregnancy: Teratogenic Effects: Pregnancy Category C: Ofloxacin has been shown to have an embryocidal effect in rats and in rabbits when given in doses of 810 mg/kg/day (equivalent to 9000 times the maximum recommended daily ophthalmic dose) and 160 mg/kg/day (equivalent to 1800 times the maximum recommended daily ophthalmic dose). These dosages resulted in decreased fetal body weight 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. Nonteratogenic Effects: Additional studies in rats with doses up to 360 mg/kg/day during late gestation showed no adverse effect 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 ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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 ophthalmic administration.

Because of the potential for serious adverse reactions from ofloxacin in nursing infants, a decision sho… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics 156 words ▾

Pharmacokinetics: Serum, urine and tear concentrations of ofloxacin were measured in 30 healthy women at various time points during a ten-day course of treatment with ofloxacin ophthalmic solution. The mean serum ofloxacin concentration ranged from 0.4 ng/mL to 1.9 ng/mL. Maximum ofloxacin concentration increased from 1.1 ng/mL on day one to 1.9 ng/mL on day 11 after QID dosing for 10 1/2 days.

Maximum serum ofloxacin concentrations after ten days of topical ophthalmic dosing were more than 1000 times lower than those reported after standard oral doses of ofloxacin. Tear ofloxacin concentrations ranged from 5.7 to 31 mcg/g during the 40 minute period following the last dose on day 11. Mean tear concentration measured four hours after topical ophthalmic dosing was 9.2 mcg/g.

Corneal tissue concentrations of 4.4 mcg/mL were observed four hours after beginning topical ocular application of two drops of ofloxacin ophthalmic solution every 30 minutes. Ofloxacin was excreted in the urine primarily unmodified.

🔬 Clinical Studies 192 words ▾

Clinical Studies: Conjunctivitis: In a randomized, double-masked, multicenter clinical trial, ofloxacin ophthalmic solution was superior to its vehicle after 2 days of treatment in patients with conjunctivitis and positive conjunctival cultures. Clinical outcomes for the trial demonstrated a clinical improvement rate of 86% (54/63) for the ofloxacin treated group versus 72% (48/67) for the placebo treated group after 2 days of therapy. Microbiological outcomes for the same clinical trial demonstrated an eradication rate for causative pathogens of 65% (41/63) for the ofloxacin treated group versus 25% (17/67) for the vehicle treated group after 2 days of therapy.

Please note that microbiologic eradication does not always correlate with clinical outcome in anti-infective trials. Corneal Ulcers: In a randomized, double-masked, multi-center clinical trial of 140 subjects with positive cultures, ofloxacin ophthalmic solution treated subjects had an overall clinical success rate (complete reepithelialization and no progression of the infiltrate for two consecutive visits) of 82% (61/74) compared to 80% (53/66) for the fortified antibiotic group, consisting of 1.5% tobramycin and 10% cefazolin solutions.

The median time to clinical success was 11 days for the ofloxacin treated group and 10 days for the fortified treatment group.

📄 Package Label / Principal Display Panel 51 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Ofloxacin Ophthalmic Solution 0.3% 5 mL Container NDC 63187-734-05 Ofloxacin Ophthalmic Solution USP Rx Only 0.3% 5 mL Active: Ofloxacin USP 0.3% Preservative: Benzalkonium Chloride (0.005%) Usual Dosage: See package insert. FOR TOPICAL OPHTHALMIC USE ONLY Retain in carton until contents are used. Protect from light. 63187-734-05

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

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.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Proficient Rx LP. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 bottle (63187-0734-10). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Proficient Rx LP is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
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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.