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Prescription medicine · generic available

Ofloxacin

Brand names: Ocuflox

Drug class: Quinolone Antimicrobial

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

Some labelsBoxed warning
None listedFDA shortage list
2Recalls (FDA reports)
29Companies
1993First FDA approval on file

Quick answers

What is Ofloxacin used for?
The FDA-approved label (Ocuflox, Allergan, Inc., June 13, 2024) says: “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 …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Ofloxacin have a boxed warning?
The label we quote has no boxed warning, but 2 of 71 FDA labels for this medicine do. Check the label of your own product.
Is there a shortage of Ofloxacin?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Ofloxacin been recalled?
FDA enforcement reports list 2 recalls of products of this medicine; the newest started April 13, 2022 (Class II). A recall usually concerns specific lots, not every product.
Who makes Ofloxacin?
29 companies list prescription products of Ofloxacin in the FDA NDC Directory, including A-S Medication Solutions, NuCare Pharmaceuticals, Inc. and Proficient Rx LP.

What Ofloxacin is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

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 …

— FDA label: Ocuflox, Allergan, Inc., effective June 13, 2024. Read the full label on DailyMed →

The FDA has 71 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

2 of 71 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsSolution · Solution/ drops · Tablet, film coated
RouteOphthalmic · Auricular (otic) · Oral
Prescription products88 in the FDA NDC Directory
Brand namesOcuflox

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Ofloxacin, by strength and form
Strength and formGeneric or brandPharmacies pay
ofloxacin 3 mg/mL
solution		 Generic $0.9940–$1.23 per mL
20 packages, lowest to highest
ofloxacin 3 mg/mL
solution/ drops		 Generic $0.9940–$1.23 per mL
19 packages, lowest to highest

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA019921
OCUFLOX		 AllerganJuly 30, 1993 15, latest November 16, 2016
2016: Labeling · 2002: Manufacturing (CMC) · 2001: Manufacturing (CMC)

Generic approvals (17)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. April 13, 2022 · Class II · Terminated · D-1114-2022

    cGMP deviations: Temperature abuse

    Ofloxacin Otic Solution 0.3%, 5 mL bottle, Rx only, MFG: Amneal/Akyma Pharmaceuticals, NDC 69238-1615-3 — Mckesson Medical-Surgical Inc. Corporate Office

  2. July 2, 2019 · Class II · Completed · D-0436-2020

    Lack of Assurance of Sterility

    Ofloxacin Ophthalmic Solution, USP, 0.3%, 5 mL, Rx only, Altaire Pharmaceuticals, Inc., NDC 59390-140-05 — Altaire Pharmaceuticals, Inc.

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)198048, 198049, 198050, 207202, 242446, 312075
SPL set ID of the quoted label7aab4449-3dda-4e2c-8e40-b3244a548bf5
FDA labels (SPL)71
FDA applicationsNDA019921, 17 ANDA
Active ingredients (FDA)OFLOXACIN

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Ocuflox, Allergan, Inc., effective June 13, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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