Quick answers
- What is Bicalutamide used for?
- The FDA-approved label (Casodex, ANI Pharmaceuticals, Inc., February 27, 2026) says: “1. INDICATIONS AND USAGE CASODEX 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. CASODEX 150 mg daily is not approved for use alone or with other treatments […]. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Bicalutamide have a boxed warning?
- No. None of the 10 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Bicalutamide?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Bicalutamide been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Bicalutamide?
- 8 companies list prescription products of Bicalutamide in the FDA NDC Directory, including ANI Pharmaceuticals, Inc., Proficient Rx LP and Accord Healthcare Inc..
What Bicalutamide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
1. INDICATIONS AND USAGE CASODEX 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. CASODEX 150 mg daily is not approved for use alone or with other treatments […]. …
— FDA label: Casodex, ANI Pharmaceuticals, Inc., effective February 27, 2026. Read the full label on DailyMed →
The FDA has 10 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.
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 10 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 10 in the FDA NDC Directory |
| Brand names | Casodex |
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 |
|---|---|---|
| bicalutamide 50 mg tablet | Generic | $0.3944 per tablet |
| bicalutamide 50 mg tablet, film coated | Generic | $0.3944 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.
- ANI Pharmaceuticals, Inc.2 products
- Proficient Rx LP2 products
- Accord Healthcare Inc.1 product
- Sun Pharmaceutical Industries, Inc.1 product
- Viona Pharmaceuticals Inc1 product
- Pinnacle Life Science Private Limited1 product
- Bryant Ranch Prepack1 product
- Golden State Medical Supply, 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 |
|---|---|---|---|
| NDA020498 CASODEX | Ani Pharms | October 4, 1995 | 17, latest November 1, 2017 2017: Labeling · 2017: Labeling · 2015: Labeling |
Generic approvals (3)
- ANDA078917Accord Hlthcare · July 6, 2009
- ANDA079089Adaptis · July 6, 2009
- ANDA079110Sun Pharm · July 6, 2009
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
| RxCUI (RxNorm) | 108828, 199123 |
|---|---|
| SPL set ID of the quoted label | dfee4fe7-8478-4a3e-925d-00be3cd0ab67 |
| FDA labels (SPL) | 10 |
| FDA applications | NDA020498, 3 ANDA |
| Active ingredients (FDA) | BICALUTAMIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Casodex, ANI Pharmaceuticals, Inc., effective February 27, 2026; 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 →