Active ingredient
Bicalutamide
10 finished FDA listings contain Bicalutamide as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- BICALUTAMIDE
- Dosage forms
- Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 8
- Strengths listed
- 50 mg/1
- Brand names in FDA listings
- Casodex
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 83008
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 020498 | ANI PHARMS | 1995-10-04 | 3 |
| ANDA 078917 | ACCORD HLTHCARE | 2009-07-06 | 3 |
| ANDA 079089 | ADAPTIS | 2009-07-06 | 2 |
| ANDA 079110 | SUN PHARM | 2009-07-06 | 2 |
Official labeling on DailyMed
- BICALUTAMIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] · version 3 · 2026-05-11
- BICALUTAMIDE TABLET [ANI PHARMACEUTICALS, INC.] · version 3 · 2026-03-09
- CASODEX (BICALUTAMIDE) TABLET [ANI PHARMACEUTICALS, INC.] · version 6 · 2026-03-05
- BICALUTAMIDE TABLET [VIONA PHARMACEUTICALS INC.] · version 1 · 2025-08-22
- BICALUTAMIDE TABLET [PINNACLE LIFE SCIENCE PRIVATE LIMITED] · version 1 · 2025-08-22
- BICALUTAMIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 8 · 2025-01-30
- BICALUTAMIDE TABLET [BRYANT RANCH PREPACK] · version 3 · 2024-05-13
- BICALUTAMIDE TABLET, FILM COATED [PROFICIENT RX LP] · version 1 · 2024-03-18
- BICALUTAMIDE TABLET [ACCORD HEALTHCARE INC.] · version 8 · 2024-01-17
- BICALUTAMIDE TABLET [PROFICIENT RX LP] · version 2 · 2022-11-14
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.