FDA Orange Book
Generic for Zyprexa Zydis
Zyprexa Zydis contains olanzapine. 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 Zyprexa Zydis is olanzapine. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Zyprexa Zydis products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, orally disintegrating, oral | 10MG | Marketed (Rx) | AB | 12 | AB |
| tablet, orally disintegrating, oral | 15MG | Marketed (Rx) | AB | 12 | AB |
| tablet, orally disintegrating, oral | 20MG | Marketed (Rx) | AB | 12 | AB |
| tablet, orally disintegrating, oral | 5MG | Marketed (Rx) | AB | 12 | AB |
NDA 021086, held by CHEPLAPHARM REGISTRATION GMBH. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic olanzapine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| APOTEX INC | 091265 | AB (A-rated, therapeutically equivalent) | October 24, 2011 | 10MG, 15MG, 20MG, 5MG |
| DR REDDYS LABORATORIES LTD | 076534 | AB (A-rated, therapeutically equivalent) | October 24, 2011 | 10MG, 15MG, 20MG, 5MG |
| STRIDES PHARMA INTERNATIONAL AG | 078109 | AB (A-rated, therapeutically equivalent) | October 24, 2011 | 10MG, 15MG, 20MG, 5MG |
| TORRENT PHARMACEUTICALS LTD | 091415 | AB (A-rated, therapeutically equivalent) | October 25, 2011 | 10MG, 15MG, 20MG, 5MG |
| BARR LABORATORIES INC | 077243 | AB (A-rated, therapeutically equivalent) | January 30, 2012 | 10MG, 15MG, 20MG, 5MG |
| JUBILANT GENERICS LTD | 200221 | AB (A-rated, therapeutically equivalent) | September 12, 2012 | 10MG, 15MG, 20MG, 5MG |
| AUROBINDO PHARMA LTD | 203708 | AB (A-rated, therapeutically equivalent) | May 15, 2014 | 10MG, 15MG, 20MG, 5MG |
| MACLEODS PHARMACEUTICALS LTD | 203044 | AB (A-rated, therapeutically equivalent) | February 20, 2015 | 10MG, 15MG, 20MG, 5MG |
| ORBION PHARMACEUTICALS PRIVATE LTD | 202937 | AB (A-rated, therapeutically equivalent) | March 2, 2015 | 10MG, 15MG, 20MG, 5MG |
| CHARTWELL MOLECULAR HOLDINGS LLC | 203456 | AB (A-rated, therapeutically equivalent) | March 16, 2016 | 10MG, 15MG, 20MG, 5MG |
| HEC PHARM USA INC | 208146 | AB (A-rated, therapeutically equivalent) | July 2, 2018 | 10MG, 15MG, 20MG, 5MG |
| HISUN PHARMACEUTICAL (HANGZHOU) CO LTD | 206892 | AB (A-rated, therapeutically equivalent) | December 31, 2020 | 10MG, 15MG, 20MG, 5MG |
Zyprexa Zydis NDC codes
Questions
Is there a generic for Zyprexa Zydis?
Yes. The generic name for Zyprexa Zydis is olanzapine. 12 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 Zyprexa Zydis?
The active ingredient in Zyprexa Zydis is olanzapine, 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.