Quick answers
- What is Ozurdex?
- Ozurdex is a brand name of Dexamethasone, a prescription medicine. The FDA NDC Directory lists 1 Ozurdex product in 1 strength and form.
- Who makes Ozurdex?
- Abbvie holds the FDA application for Ozurdex (NDA022315, approved June 17, 2009).
- Is there a generic or store brand of Ozurdex?
- Other products of Dexamethasone are listed with the FDA, but none in exactly the same strength and form as a Ozurdex product.
- Has Ozurdex been recalled?
- FDA enforcement reports list 1 recall of Ozurdex products; the newest started December 20, 2018. A recall usually concerns specific lots, not every product.
What Ozurdex is
Each Ozurdex 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.
Dexamethasone · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| dexamethasone 0.7 mg implant (intravitreal) | Ozurdex | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Dexamethasone →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA022315 | Abbvie | June 17, 2009 | 1 |
Companies that list Ozurdex
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Ozurdex products.
- Allergan, 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.
-
December 20, 2018 · Class II · Completed · D-0387-2019
GMP Deviations: A silicone particulate was noted in Ozurdex.
OZURDEX (dexamethasone intravitreal implant) 0.7 mg), 1 single-use plastic applicator contained within carton, Rx only, Allergan Inc Irvine, CA 92612, NDC 0023-3348-07 — Allergan, PLC.
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.