Quick answers
- What is Zaditor?
- Zaditor is a brand name of Ketotifen, an over-the-counter medicine. The FDA NDC Directory lists 1 Zaditor product in 1 strength and form.
- Who makes Zaditor?
- Alcon Pharms Ltd holds the FDA application for Zaditor (ANDA077200, approved September 2, 2008).
- Is there a generic or store brand of Zaditor?
- Yes. The FDA NDC Directory lists 7 other products with the same active ingredients, strength and form as a Zaditor product, 2 of them generic or store brands. Ask your pharmacist whether one is right for you.
- What do pharmacies pay for Zaditor?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 1 Zaditor strength and form (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 Zaditor been recalled?
- FDA enforcement reports list 1 recall of Zaditor products; the newest started June 29, 2022. A recall usually concerns specific lots, not every product.
What Zaditor is
Each Zaditor 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.
Ketotifen · over-the-counter medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| ketotifen fumarate 0.25 mg/mL solution (ophthalmic) | Zaditor | 7 products, 7 companies | DailyMed |
Its page quotes the Drug Facts label and lists every brand and store brand: Ketotifen →
FDA approval
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| ANDA077200 | Alcon Pharms Ltd | September 2, 2008 | 1 |
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 |
|---|---|---|
| ketotifen fumarate 0.25 mg/mL solution | Brand: Zaditor | $1.87–$2.23 per mL 2 packages, lowest to highest Generic of the same strength and form: $1.29 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 Zaditor
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Zaditor products.
- Alcon Laboratories, Inc.1 product
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 29, 2022 · Class II · Terminated · D-1317-2022
CGMP Deviations: products were stored outside the drug label specifications.
Systane Zaditor, ketotifen fumarate ophthalmic solution 0.035%, Antihistamine eye drops, Eye Itch Relief, up to 12 Hours, Sterile, 30 day supply, 5mL (0.17 FL OZ) bottle per box, Alcon, NDC 0065-4011-05. — Mckesson Medical-Surgical Inc. Corporate Office
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.