Quick answers
- What is TobraDex?
- TobraDex is a brand name of Tobramycin and dexamethasone, a prescription medicine. The FDA NDC Directory lists 1 TobraDex product in 1 strength and form.
- Who makes TobraDex?
- Novartis holds the FDA application for TobraDex (NDA050616, approved September 28, 1988).
- Is there a generic or store brand of TobraDex?
- Other products of Tobramycin and dexamethasone are listed with the FDA, but none in exactly the same strength and form as a TobraDex product.
- What do pharmacies pay for TobraDex?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 1 TobraDex 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 TobraDex been recalled?
- FDA enforcement reports list 1 recall of TobraDex products; the newest started April 13, 2022. A recall usually concerns specific lots, not every product.
What TobraDex is
Each TobraDex 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.
Tobramycin and dexamethasone · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| dexamethasone 0.1% · tobramycin 0.3% ointment (ophthalmic) | TobraDex | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Tobramycin and dexamethasone →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA050616 | Novartis | September 28, 1988 | 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 |
|---|---|---|
| dexamethasone 0.1% · tobramycin 0.3% ointment | Brand: TobraDex | $89.68 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 TobraDex
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of TobraDex products.
- Novartis Pharmaceuticals Corporation1 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.
-
April 13, 2022 · Class II · Terminated · D-0995-2022
cGMP deviations: Temperature abuse
TobraDex (tobramycin and dexamethasone), Ophthalmic Ointment, 3.5 gm, Rx only, Manufacturer: Novartis, NDC 0078-0876-01 — 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.