Quick answers
- What is Iluvien?
- Iluvien is a brand name of Fluocinolone acetonide, a prescription medicine. The FDA NDC Directory lists 1 Iluvien product in 1 strength and form.
- Who makes Iluvien?
- Alimera Sciences Inc holds the FDA application for Iluvien (NDA201923, approved September 26, 2014).
- Is there a generic or store brand of Iluvien?
- Other products of Fluocinolone acetonide are listed with the FDA, but none in exactly the same strength and form as a Iluvien product.
- Has Iluvien been recalled?
- No recall linked to Iluvien products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Iluvien is
Each Iluvien 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.
Fluocinolone acetonide · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| fluocinolone acetonide 0.19 mg implant (intravitreal) | Iluvien | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Fluocinolone acetonide →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA201923 | Alimera Sciences Inc | September 26, 2014 | 1 |
Companies that list Iluvien
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Iluvien products.
- ANI Pharmaceuticals, Inc.1 product
Recalls
No recall linked to Iluvien products (by their NDC code or label) appears in the FDA enforcement reports.
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.