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OCUFLOX ofloxacin 3 mg/mL Solution/ Drops — NDC 11980-0779-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

OCUFLOX ofloxacin 3 mg/mL Solution/ Drops — NDC 11980-779-05 (Billing 11980-0779-05)

by Allergan, Inc. · 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER

This is a package of OCUFLOX ofloxacin 3 mg/mL Solution/ Drops from Allergan, Inc., marketed since Aug 1993 and currently FDA-listed. It is this product's only package size.

NDC 11980-0779-05
🏷️ FDA NDC (as labeled) 11980-779-05 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 11980-779-05
Product NDC 11980-779
11-digit billing NDC 11980077905
NCPDP billing unit ML — per mL (volume)
RxCUI 207202, 312075
UNII A4P49JAZ9H
Application # NDA019921
SPL Set ID 7aab4449-3dda-4e2c-8e40-b3244a548bf5
Established class (EPC) Quinolone Antimicrobial
Chemical class Quinolones
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1993-08-01
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
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 Ocuflox
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 OCUFLOX 0.3% EYE DROPS
FDB brand name Ocuflox
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): 207202
Why two NDCs? The FDA registers this code as 11980-779-05 — 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 → 11980-0779-05. 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 OCUFLOX 0.3% EYE DROPS Ingredient Ofloxacin
📖 What it is MedlinePlus · NLM

Ophthalmic ofloxacin ophthalmic is used to treat bacterial infections of the eye, including conjunctivitis (pink eye) and ulcers of the cornea. Ofloxacin is in a class of medications called quinolone antibiotics. It works by killing bacterial cells that cause infection.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats bacterial eye infections, specifically bacterial conjunctivitis (pink eye) and bacterial corneal ulcers. It only works on infections caused by bacteria that are sensitive...
  • It depends on the infection. Conjunctivitis dosing is every few hours at first, then four times a day. Corneal ulcers need much more frequent dosing at the start, even during the n...
  • The most common is brief burning or discomfort in the eye. Stinging, redness, itching, blurry vision, watery or dry eyes, light sensitivity and eye pain can also happen. These are...
  • Stop the drops and get emergency help if you have trouble breathing, swelling of your face, lips or throat, hives, or feel faint. These can be signs of a serious allergic reaction....
📖 Read our full Ofloxacin Ophthalmic 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 $3.80 $19.01 / 5 ml
Medicare drug plans payPart D · Q2 2026 $24.41 $122.07 / 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
11980-0779-05 You're viewing this Main listing 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER 1993-08-01 — Active

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/mLthis 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/mL 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 the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
1993
On the market since
Aug 1993
📍
2026
Currently FDA-listed
33 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

💡 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

LabelerAllergan, Inc.
Application holderALLERGAN INC
FDA applicationNDA019921 (NDA)
Labeler code11980
First marketedAug 1993
Product typeHuman Prescription Drug
Portfolio188 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 77 words ▾

INDICATIONS AND USAGE OCUFLOX ® 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 118 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 through treatment completion Instill one to two drops, four times daily.

⛔ Contraindications 33 words ▾

CONTRAINDICATIONS OCUFLOX ® solution is contraindicated in patients with a history of hypersensitivity to ofloxacin, to other quinolones, or to any of the components in this medication ( s ee Warnings ) .

⚠️ Warnings 126 words ▾

WARNINGS NOT FOR INJECTION. OCUFLOX ® solution should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye. There are rare reports of anaphylactic reaction/shock and fatal hypersensitivity reactions in patients receiving systemic quinolones, some following the first dose, 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 55 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 received. Refer to Warnings for additional adverse reactions.

🔄 Drug Interactions 64 words ▾

Drug Interactions Specific drug interaction studies have not been conducted with OCUFLOX ® 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.

🤰 Pregnancy 103 words ▾

Pregnancy Teratogenic Effects 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.

🧒 Pediatric Use 64 words ▾

Pediatric Use Safety and effectiveness in infants below the age of one year have not been established. Quinolones, including ofloxacin, have been shown to cause arthropathy in immature animals after oral administration; however, topical ocular administration of ofloxacin to immature animals has not shown any arthropathy. There is no evidence that the ophthalmic dosage form of ofloxacin has any effect on weight bearing joints.

🧓 Geriatric Use 17 words ▾

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

🧬 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 OCUFLOX ® 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 OCUFLOX ® 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 ( see Indications and Usage ) . AEROBES, GRAM-POSITIVE: AEROBES, GRAM-NEGATIVE: Staphylococcus aureus Enterobacter cloacae Staphylococcus epidermidis Haemophilus influenzae Streptococcus pneumoniae Proteus mirabilis ANAEROBIC SPECIES: Pseudomonas aeruginosa Propionibacterium acnes Serratia marcescens* *Efficacy for this organism was studied in fewer than 10 infections The safety and effectiveness of OCUFLOX ® ophthalmic solution in treating ophthalmologic infections due to the following organisms have not been established in adequate and well-controlled clinical trials.

OCUFLOX ® 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, OCUFLOX ® 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 al…

📦 How Supplied / Storage and Handling 78 words ▾

HOW SUPPLIED OCUFLOX ® (ofloxacin ophthalmic solution) 0.3% is supplied sterile in opaque white LDPE plastic bottles and white dropper tips with tan high impact polystyrene (HIPS) caps as follows: 5mL in 10mL bottle - NDC 11980-779-05 Note: Store at 15°-25°C (59°-77°F) Rx only Revised : 0 6 /2024 Distributed by: AbbVie, Inc. North Chicago, IL 60064 © 2024 AbbVie. All rights reserved.

Ocuflox and its design are trademarks of Allergan, Inc., an AbbVie company. 20085528 Abbie logo

📋 Description 114 words ▾

DESCRIPTION OCUFLOX ® (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-7 H -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 purified water.

May also contain hydrochloric acid and/or sodium hydroxide to adjust pH. OCUFLOX ® 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. (±)-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.

💬 Information for Patients 49 words ▾

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.

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 – Q4 2025 · 4 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
11
Units reimbursed last 4 qtrs
12
Gross reimbursed last 4 qtrs
$45.63
Avg / prescription
$4.15
Avg / unit
$3.8025
Latest quarter Q4 2025
0Rx
Fee-for-service vs managed care ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 11 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 12 units · 0.0 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.00.0
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 California 0.0 /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 Ocuflox — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Ocuflox. 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
$3.5K
Claims incl. refills
37
Beneficiaries
32
Spend / beneficiary
$110.33
Spend / claim
$95.42
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

7,263 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.

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 ✓ Available
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) ✓ Available
“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 Allergan, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Allergan, Inc. 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.
← 11980-0228-05 · Allergan, 11988-0001-01 · Lubbock →
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.