FDA Orange Book
Generic for Casodex
Casodex contains bicalutamide. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Casodex is bicalutamide. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Casodex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 50MG | Marketed (Rx) | AB | 6 | AB |
NDA 020498, held by ANI PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic bicalutamide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACCORD HEALTHCARE INC | 078917 | AB (A-rated, therapeutically equivalent) | July 6, 2009 | 50MG |
| ADAPTIS PHARMA PRIVATE LTD | 079089 | AB (A-rated, therapeutically equivalent) | July 6, 2009 | 50MG |
| SANDOZ INC | 078575 | AB (A-rated, therapeutically equivalent) | July 6, 2009 | 50MG |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 079110 | AB (A-rated, therapeutically equivalent) | July 6, 2009 | 50MG |
| WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | 078634 | AB (A-rated, therapeutically equivalent) | August 28, 2009 | 50MG |
| CHARTWELL RX SCIENCES LLC | 091011 | AB (A-rated, therapeutically equivalent) | June 10, 2015 | 50MG |
Casodex NDC codes
Questions
Is there a generic for Casodex?
Yes. The generic name for Casodex is bicalutamide. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Casodex?
The active ingredient in Casodex is bicalutamide, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.