FDA Orange Book
Generic for Fazaclo ODT
Fazaclo ODT 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 Fazaclo ODT is clozapine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 5 of the 6 Fazaclo ODT products the Orange Book lists.
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Fazaclo ODT products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, orally disintegrating, oral | 100MG | Discontinued | None | 3 | AB |
| tablet, orally disintegrating, oral | 12.5MG | Discontinued | None | 2 | AB |
| tablet, orally disintegrating, oral | 150MG | Discontinued | None | 3 | AB |
| tablet, orally disintegrating, oral | 200MG | Discontinued | None | 3 | AB |
| tablet, orally disintegrating, oral | 25MG | Discontinued | None | 3 | AB |
| tablet, orally disintegrating, oral | 50MG | Discontinued | None | 0 | None |
NDA 021590, held by JAZZ PHARMACEUTICALS IRELAND LTD. 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 |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 201824 | AB (A-rated, therapeutically equivalent) | September 15, 2015 | 100MG, 150MG, 200MG, 25MG |
| BARR LABORATORIES INC | 090308 | AB (A-rated, therapeutically equivalent) | November 25, 2015 | 100MG, 12.5MG, 150MG, 200MG, 25MG |
| AUROBINDO PHARMA LTD | 212923 | AB (A-rated, therapeutically equivalent) | December 12, 2024 | 100MG, 12.5MG, 150MG, 200MG, 25MG |
Questions
Is there a generic for Fazaclo ODT?
Yes. The generic name for Fazaclo ODT is clozapine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 5 of the 6 Fazaclo ODT products the Orange Book lists.
What is the generic name for Fazaclo ODT?
The active ingredient in Fazaclo ODT 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.