FDA Orange Book
Generic for Clozaril
Clozaril contains clozapine. 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 Clozaril is clozapine. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Clozaril products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Marketed (Rx) | AB | 5 | AB |
| tablet, oral | 200MG | Discontinued | None | 3 | AB |
| tablet, oral | 25MG | Marketed (Rx) | AB | 4 | AB |
| tablet, oral | 50MG | Discontinued | None | 4 | AB |
NDA 019758, held by HERITAGE LIFE SCIENCES BARBADOS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic clozapine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA | 074949 | AB (A-rated, therapeutically equivalent) | November 26, 1997 | 100MG, 25MG, 50MG |
| MYLAN PHARMACEUTICALS INC | 075417 | AB (A-rated, therapeutically equivalent) | May 27, 1999 | 100MG, 200MG, 25MG, 50MG |
| IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA | 076809 | AB (A-rated, therapeutically equivalent) | December 16, 2005 | 100MG, 200MG, 50MG |
| ACCORD HEALTHCARE INC | 202873 | AB (A-rated, therapeutically equivalent) | November 25, 2015 | 100MG, 25MG |
| AUROBINDO PHARMA LTD | 206433 | AB (A-rated, therapeutically equivalent) | November 29, 2016 | 100MG, 200MG, 25MG, 50MG |
Clozaril NDC codes
Questions
Is there a generic for Clozaril?
Yes. The generic name for Clozaril is clozapine. 4 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 Clozaril?
The active ingredient in Clozaril is clozapine, 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.