Quick answers
- What is Abiraterone acetate used for?
- The FDA-approved label (Zytiga, Janssen Biotech, Inc., March 28, 2025) says: “ZYTIGA is indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC) Metastatic high-risk castration-sensitive prostate cancer (CSPC) ZYTIGA is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Abiraterone acetate have a boxed warning?
- No. None of the 28 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Abiraterone acetate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Abiraterone acetate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Abiraterone acetate?
- 24 companies list prescription products of Abiraterone acetate in the FDA NDC Directory, including NorthStar Rx LLC, Novadoz Pharmaceuticals LLC and Dr.Reddys Laboratories Inc.
What Abiraterone acetate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ZYTIGA is indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC) Metastatic high-risk castration-sensitive prostate cancer (CSPC) ZYTIGA is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). …
— FDA label: Zytiga, Janssen Biotech, Inc., effective March 28, 2025. Read the full label on DailyMed →
The FDA has 28 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 28 FDA labels for this medicine have a boxed warning.
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| abiraterone acetate 250 mg tablet | Generic | $0.7882 per tablet |
| abiraterone acetate 250 mg tablet, film coated | Generic | $0.7882 per tablet |
| abiraterone acetate 500 mg tablet | Generic | $2.51 per tablet |
| abiraterone acetate 500 mg tablet, film coated | Generic | $2.51 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- NorthStar Rx LLC3 products
- Novadoz Pharmaceuticals LLC3 products
- Dr.Reddys Laboratories Inc3 products
- Novugen Pharma (USA) LLC2 products
- Glenmark Pharmaceuticals Inc., USA2 products
- Amneal Pharmaceuticals NY LLC2 products
- Mylan Pharmaceuticals Inc.2 products
- AvKARE2 products
- Apotex Corp.2 products
- Quallent Pharmaceuticals Health LLC2 products
- Golden State Medical Supply, Inc.2 products
- Amneal Pharmaceuticals LLC2 products
- BluePoint Laboratories2 products
- CivicaScript LLC2 products
- Janssen Biotech, Inc.2 products
- Florida Pharmaceutical Products, LLC2 products
- American Health Packaging1 product
- Rising Pharma Holdings, Inc.1 product
- PD-Rx Pharmaceuticals, Inc.1 product
- Hikma Pharmaceuticals USA Inc.1 product
- AvPAK1 product
- Bryant Ranch Prepack1 product
- Major Pharmaceuticals1 product
- Sun Pharmaceutical Industries, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA202379 ZYTIGA | Janssen Biotech | April 28, 2011 | 25, latest August 23, 2021 2021: Labeling · 2020: Labeling · 2020: Labeling |
| NDA210308 YONSA | Sun Pharm | May 22, 2018 | 4, latest May 13, 2026 2026: Labeling · 2022: Labeling · 2022: Labeling |
Generic approvals (11)
- ANDA208339Hikma · October 31, 2018
- ANDA208446Mylan · October 31, 2018
- ANDA208453Apotex · October 31, 2018
- ANDA208327Amneal Pharms · January 7, 2019
- ANDA208371Rising · February 25, 2019
- ANDA210686Msn · July 10, 2019
- ANDA212462Qilu · September 27, 2019
- ANDA209227Glenmark Speclt · October 16, 2019
- ANDA208416DR Reddys · May 18, 2020
- ANDA215947Novugen · January 5, 2022
- ANDA215086Regcon Holdings · March 23, 2023
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Zytiga, Janssen Biotech, Inc., effective March 28, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- 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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →