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Brand-name prescription medicine

Dextenza

Generic name: Dexamethasone

FDA application holder: Ocular Therapeutix

Official data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the NDC Directory, Drugs@FDA, the official labels and recall reports; pharmacy costs come from the Centers for Medicare & Medicaid Services (CMS). Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or switch any medicine, including a switch between a brand and a generic.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Quick answers

What is Dextenza?
Dextenza is a brand name of Dexamethasone, a prescription medicine. The FDA NDC Directory lists 1 Dextenza product in 1 strength and form.
Who makes Dextenza?
Ocular Therapeutix holds the FDA application for Dextenza (NDA208742, approved November 30, 2018).
Is there a generic or store brand of Dextenza?
Other products of Dexamethasone are listed with the FDA, but none in exactly the same strength and form as a Dextenza product.
Has Dextenza been recalled?
No recall linked to Dextenza products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Dextenza is

Each Dextenza 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 formProduct namesSame medicine, other namesLabel
dexamethasone 0.4 mg
insert (intracanalicular, ophthalmic)
Dextenza 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.
FDA applications of Dextenza products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
NDA208742Ocular TherapeutixNovember 30, 20181

Companies that list Dextenza

The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Dextenza products.

Recalls

No recall linked to Dextenza products (by their NDC code or label) appears in the FDA enforcement reports.

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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.

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