Quick answers
- What is Lotemax?
- Lotemax is a brand name of Loteprednol etabonate, a prescription medicine. The FDA NDC Directory lists 3 Lotemax products in 3 strengths and forms.
- Who makes Lotemax?
- Bausch and Lomb holds the FDA application for Lotemax (NDA020583, approved March 9, 1998).
- Is there a generic or store brand of Lotemax?
- Yes. The FDA NDC Directory lists 11 other products with the same active ingredients, strength and form as a Lotemax product, 11 of them generic. Ask your pharmacist whether one is right for you.
- What do pharmacies pay for Lotemax?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 2 Lotemax strengths and forms (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
- Has Lotemax been recalled?
- FDA enforcement reports list 1 recall of Lotemax products; the newest started June 17, 2019. A recall usually concerns specific lots, not every product.
What Lotemax is
Each Lotemax product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Loteprednol etabonate · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| loteprednol etabonate 0.5% gel (ophthalmic) | Lotemax | 4 products, 4 companies | DailyMed |
| loteprednol etabonate 0.5% ointment (ophthalmic) | Lotemax | None listed | DailyMed |
| loteprednol etabonate 5 mg/mL suspension/ drops (ophthalmic) | Lotemax | 7 products, 7 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Loteprednol etabonate →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
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 |
|---|---|---|
| loteprednol etabonate 0.5% gel | Brand: Lotemax | $49.66 per gram Generic of the same strength and form: $18.83 per gram |
| loteprednol etabonate 0.5% ointment | Brand: Lotemax | $99.74 per gram |
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 Lotemax
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Lotemax products.
- Bausch & Lomb Incorporated3 products
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
June 17, 2019 · Class III · Terminated · D-1396-2019
Failed Stability Specifications: Out of specification for viscosity.
Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch & Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, NDC 24208-503-07. — Bausch & Lomb
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.