Quick answers
- What is Gatifloxacin used for?
- The FDA-approved label (Zymaxid, Allergan, Inc., September 8, 2016) says: “ZYMAXID ® is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Aerobic gram-positive bacteria: Staphylococcus aureus Staphylococcus epidermidis Streptococcus mitis group * Streptococcus oralis * Streptococcus pneumoniae Aerobic gram-negative bacteria: Haemophilus influenzae *Efficacy for these organisms were studied in fewer than 10 infections. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Gatifloxacin have a boxed warning?
- No. None of the 4 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Gatifloxacin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Gatifloxacin been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started October 17, 2019 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Gatifloxacin?
- 4 companies list prescription products of Gatifloxacin in the FDA NDC Directory, including Caplin Steriles Limited, Leading Pharma, LLC and Allergan, Inc..
What Gatifloxacin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ZYMAXID ® is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Aerobic gram-positive bacteria: Staphylococcus aureus Staphylococcus epidermidis Streptococcus mitis group * Streptococcus oralis * Streptococcus pneumoniae Aerobic gram-negative bacteria: Haemophilus influenzae *Efficacy for these organisms were studied in fewer than 10 infections. …
— FDA label: Zymaxid, Allergan, Inc., effective September 8, 2016. Read the full label on DailyMed →
The FDA has 4 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.
0 of 4 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Solution · Solution/ drops |
|---|---|
| Route | Ophthalmic |
| Prescription products | 4 in the FDA NDC Directory |
| Brand names | Zymaxid |
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.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| gatifloxacin 5 mg/mL solution/ drops | Generic | $9.47 per mL |
| gatifloxacin anhydrous 5 mg/mL solution | Generic | $9.47 per mL |
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.
- Caplin Steriles Limited1 product
- Leading Pharma, LLC1 product
- Allergan, Inc.1 product
- Sandoz Inc1 product
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.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022548 ZYMAXID | Abbvie | May 18, 2010 | 2, latest September 8, 2016 2016: Labeling · 2014: Manufacturing (CMC) |
Generic approvals (2)
- ANDA204227Sandoz · July 11, 2016
- ANDA213542Caplin · November 3, 2021
Shortage status
The FDA drug shortage list does not show these products.
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.
-
October 17, 2019 · Class III · Terminated · D-0163-2020
Labeling: Incorrect or missing package insert.
Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, Product of India, ND — Sandoz 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) | 992395, 992399 |
|---|---|
| SPL set ID of the quoted label | 1160b16c-929a-4e85-9c0b-1d8c96a7678b |
| FDA labels (SPL) | 4 |
| FDA applications | NDA022548, 2 ANDA |
| Active ingredients (FDA) | GATIFLOXACIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Zymaxid, Allergan, Inc., effective September 8, 2016; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- 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 →