Prescription medicine
Loteprednol and tobramycin Brand names: Zylet
Loteprednol and tobramycin (Zylet) is a prescription medicine with an FDA approval on record since 2004. FDA's NDC Directory lists it from 2 generic labelers, and pharmacies paid $39.26 per mL (Tobramycin-loteprednol 0.3%-0.5% eye drop) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the loteprednol and tobramycin FDA label on DailyMed (effective April 30, 2022, Bausch & Lomb Incorporated); the NDA 50804 record on Drugs@FDA; every loteprednol and tobramycin label on DailyMed.
Highlights of the record
FDA label of April 30, 2022; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageZYLET ® (loteprednol etabonate and tobramycin ophthalmic suspension), 0.5%/0.3% is a topical anti-infective and corticosteroid combination for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.
Forms and strengths
- 5 mg/ml / 3 mg/ml
Suspension/ drops; solution/ drops.
On the market
- Earliest approval on file
- December 14, 2004 Zylet, Bausch And Lomb; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first December 10, 2025; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 2 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $39.26 per mL Tobramycin-loteprednol 0.3%-0.5% eye drop
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 400 through July 30, 2026
What is loteprednol and tobramycin used for?
From the label: indications and usageZYLET ® (loteprednol etabonate and tobramycin ophthalmic suspension), 0.5%/0.3% is a topical anti-infective and corticosteroid combination for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. […]
FDA pharmacologic class: Aminoglycoside Antibacterial and Corticosteroid.
Source: FDA drug label (Zylet), Bausch & Lomb Incorporated, effective April 30, 2022 (SPL set 3dd9b060-5355-404d-bdf1-09ee8b52a9f5), via openFDA; the full label on DailyMed
Is there a generic for loteprednol and tobramycin (Zylet)?
The FDA approved the first generic loteprednol and tobramycin on December 10, 2025. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists loteprednol and tobramycin from 2 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.
- 2004 earliest approval on file
- 2025 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for loteprednol and tobramycin (Zylet)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $39.26 per mL (Tobramycin-loteprednol 0.3%-0.5% eye drop). 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.
- Tobramycin-loteprednol 0.3%-0.5% eye drop (generic)
- Zylet eye drops (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Tobramycin-loteprednol 0.3%-0.5% eye drop | Generic | $39.26 per mL | n/a | n/a |
| Zylet eye drops | Brand | $64.41 per mL | n/a | -0.3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the loteprednol and tobramycin label say about other medicines?
The loteprednol and tobramycin label names 2 other medicines in its interaction, contraindication or warning sections. 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 |
|---|---|---|
| Benzalkonium | warnings and precautions | As with all ophthalmic preparations containing benzalkonium chloride, patients should be advised not to wear soft contact lenses when using ZYLET. |
| Fluorescein | warnings and precautions | The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of a magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. |
Source: FDA drug label (Zylet), Bausch & Lomb Incorporated, effective April 30, 2022 (SPL set 3dd9b060-5355-404d-bdf1-09ee8b52a9f5), via openFDA; the full label on DailyMed
What do FAERS reports show for loteprednol and tobramycin?
The FDA Adverse Event Reporting System holds 400 reports that list loteprednol and tobramycin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 9 are coded as a death and 40 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other aminoglycoside antibacterials
- the pharmacologic class, with prices and generics
- Loteprednol and tobramycin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other