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Brand-name prescription medicine

Oxaydo

Generic name: Oxycodone hydrochloride

FDA application holder: Zyla

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 Oxaydo?
Oxaydo is a brand name of Oxycodone hydrochloride, a prescription medicine. The FDA NDC Directory lists 2 Oxaydo products in 2 strengths and forms.
Who makes Oxaydo?
Zyla holds the FDA application for Oxaydo (NDA202080, approved June 17, 2011).
Is there a generic or store brand of Oxaydo?
Yes. The FDA NDC Directory lists 31 other products with the same active ingredients, strength and form as a Oxaydo product, 31 of them generic. Ask your pharmacist whether one is right for you.
Has Oxaydo been recalled?
FDA enforcement reports list 1 recall of Oxaydo products; the newest started October 20, 2023. A recall usually concerns specific lots, not every product.

What Oxaydo is

Each Oxaydo 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.

Oxycodone hydrochloride · prescription medicine

Strength and formProduct namesSame medicine, other namesLabel
oxycodone hydrochloride 5 mg
tablet (oral)
Oxaydo 31 products, 19 companies DailyMed
oxycodone hydrochloride 7.5 mg
tablet (oral)
Oxaydo None listed DailyMed

Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Oxycodone hydrochloride →

FDA approval

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
FDA applications of Oxaydo products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
NDA202080ZylaJune 17, 20112

Companies that list Oxaydo

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

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.

  1. October 20, 2023 · Class III · Ongoing · D-0094-2024

    Sub-potent Drug: Lower potency than labeled.

    Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only, Distributed by: Zyla Life Sciences US Inc., Wayne, PA 19087. NDC: 69344-213-11 — Zyla Life Sciences US Inc.

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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