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Brand-name prescription medicine

Zytiga

Generic name: Abiraterone acetate

FDA application holder: Janssen Biotech

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 Zytiga?
Zytiga is a brand name of Abiraterone acetate, a prescription medicine. The FDA NDC Directory lists 2 Zytiga products in 2 strengths and forms.
Who makes Zytiga?
Janssen Biotech holds the FDA application for Zytiga (NDA202379, approved April 28, 2011).
Is there a generic or store brand of Zytiga?
Yes. The FDA NDC Directory lists 30 other products with the same active ingredients, strength and form as a Zytiga product, 30 of them generic. Ask your pharmacist whether one is right for you.
Has Zytiga been recalled?
No recall linked to Zytiga products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Zytiga is

Each Zytiga 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.

Abiraterone acetate · prescription medicine

Strength and formProduct namesSame medicine, other namesLabel
abiraterone acetate 250 mg
tablet (oral)
Zytiga 22 products, 19 companies DailyMed
abiraterone acetate 500 mg
tablet, film coated (oral)
Zytiga 8 products, 8 companies DailyMed

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

FDA approval

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
FDA applications of Zytiga products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
NDA202379Janssen BiotechApril 28, 20112

Companies that list Zytiga

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

Recalls

No recall linked to Zytiga 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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