Prescription medicine
Gatifloxacin Brand names: Zymaxid; first approved as Zymar
Gatifloxacin (Zymaxid) is a prescription medicine with an FDA approval on record since 2003. FDA's NDC Directory lists it from 3 generic labelers, and pharmacies paid $8.85 per mL (Gatifloxacin 0.5% eye drops) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the gatifloxacin FDA label on DailyMed (effective September 8, 2016, Allergan, Inc.); the NDA 21493 record on Drugs@FDA; every gatifloxacin label on DailyMed.
Highlights of the record
FDA label of September 8, 2016; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageZYMAXID ® 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.
Forms and strengths
- 5 mg/ml
Solution/ drops; solution.
On the market
- Earliest approval on file
- March 28, 2003 Zymar, Allergan; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first August 19, 2011; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 3 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $8.85 per mL Gatifloxacin 0.5% eye drops
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2013 0 Class I among all firms' recalls; latest December 22, 2021; 1 more by firms not listed as its makers
- FAERS reports
- 1,776 through July 30, 2026
What is gatifloxacin used for?
From the label: indications and usageZYMAXID ® 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 pharmacologic class: Quinolone Antimicrobial.
Source: FDA drug label (ZYMAXID), NDA022548 (Abbvie), as published by Allergan, Inc., effective September 8, 2016 (SPL set 1160b16c-929a-4e85-9c0b-1d8c96a7678b), via openFDA; the full label on DailyMed
Is there a generic for gatifloxacin (Zymaxid)?
The FDA approved the first generic gatifloxacin on August 19, 2011. 6 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists gatifloxacin from 3 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2003 earliest approval on file
- 2011 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for gatifloxacin (Zymaxid)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $8.85 per mL (Gatifloxacin 0.5% eye drops), down 23% from $11.52 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Gatifloxacin 0.5% eye drops (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Gatifloxacin 0.5% eye drops | Generic | $8.85 per mL | n/a | -23% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has gatifloxacin been recalled?
The FDA's Enforcement Report lists 4 recalls naming gatifloxacin since 2013: 0 Class I (the most serious), 1 Class II, 3 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of gatifloxacin and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 22, 2021 | Class III | Lupin Pharmaceuticals Inc. | Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration. |
| October 20, 2021 | Class III | Lupin Pharmaceuticals Inc. | Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration. |
| October 17, 2019 | Class III | Sandoz Inc | Labeling: Incorrect or missing package insert. |
| October 19, 2013 | Class II | Specialty Medicine Compounding Pharmacy not a listed maker | Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the gatifloxacin label say about other medicines?
The gatifloxacin label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 13 other medicines name gatifloxacin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Fluorescein | warnings and precautions | Whenever clinical judgment dictates, examine the patient with the aid of magnification, such as slit lamp biomicroscopy and where appropriate, fluorescein staining. |
Other labels that name gatifloxacin
Source: FDA drug label (ZYMAXID), NDA022548 (Abbvie), as published by Allergan, Inc., effective September 8, 2016 (SPL set 1160b16c-929a-4e85-9c0b-1d8c96a7678b), via openFDA; the full label on DailyMed
What do FAERS reports show for gatifloxacin?
The FDA Adverse Event Reporting System holds 1,776 reports that list gatifloxacin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 105 are coded as a death and 687 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other quinolone antimicrobials
- the pharmacologic class, with prices and generics
- Gatifloxacin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other