FDA Orange Book
Generic for Zyprexa
Zyprexa 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 is olanzapine. 19 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
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Zyprexa products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intramuscular | 10MG/VIAL | Marketed (Rx) | AP | 8 | AP |
| tablet, oral | 10MG | Marketed (Rx) | AB | 12 | AB |
| tablet, oral | 15MG | Marketed (Rx) | AB | 12 | AB |
| tablet, oral | 2.5MG | Marketed (Rx) | AB | 12 | AB |
| tablet, oral | 20MG | Marketed (Rx) | AB | 12 | AB |
| tablet, oral | 5MG | Marketed (Rx) | AB | 12 | AB |
| tablet, oral | 7.5MG | Marketed (Rx) | AB | 12 | AB |
NDA 021253, 020592, 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 |
|---|---|---|---|---|
| SANDOZ INC | 201588 | AP (A-rated, therapeutically equivalent) | October 24, 2011 | 10MG/VIAL |
| AMERICAN REGENT INC | 201741 | AP (A-rated, therapeutically equivalent) | March 20, 2012 | 10MG/VIAL |
| APOTEX INC | 090798 | AB (A-rated, therapeutically equivalent) | April 23, 2012 | 10MG, 15MG, 2.5MG, 20MG, 5MG, 7.5MG |
| AUROBINDO PHARMA LTD | 202050 | AB (A-rated, therapeutically equivalent) | April 23, 2012 | 10MG, 15MG, 2.5MG, 20MG, 5MG, 7.5MG |
| DR REDDYS LABORATORIES LTD | 076255 | AB (A-rated, therapeutically equivalent) | April 23, 2012 | 10MG, 2.5MG, 5MG, 7.5MG |
| ORBION PHARMACEUTICALS PRIVATE LTD | 202287 | AB (A-rated, therapeutically equivalent) | April 23, 2012 | 10MG, 15MG, 2.5MG, 20MG, 5MG, 7.5MG |
| TORRENT PHARMACEUTICALS LTD | 091434 | AB (A-rated, therapeutically equivalent) | April 23, 2012 | 10MG, 15MG, 2.5MG, 20MG, 5MG, 7.5MG |
| DR REDDYS LABORATORIES LTD | 076133 | AB (A-rated, therapeutically equivalent) | April 23, 2012 | 15MG, 20MG |
| MACLEODS PHARMACEUTICALS LTD | 202862 | AB (A-rated, therapeutically equivalent) | August 15, 2014 | 10MG, 15MG, 2.5MG, 20MG, 5MG, 7.5MG |
| ALKEM LABORATORIES LTD | 202295 | AB (A-rated, therapeutically equivalent) | October 20, 2015 | 10MG, 15MG, 2.5MG, 20MG, 5MG, 7.5MG |
| QILU PHARMACEUTICAL CO LTD | 204319 | AB (A-rated, therapeutically equivalent) | January 27, 2016 | 10MG, 15MG, 2.5MG, 20MG, 5MG, 7.5MG |
| CHARTWELL MOLECULAR HOLDINGS LLC | 203333 | AB (A-rated, therapeutically equivalent) | March 15, 2016 | 10MG, 15MG, 2.5MG, 20MG, 5MG, 7.5MG |
| ZYDUS PHARMACEUTICALS USA INC | 090459 | AB (A-rated, therapeutically equivalent) | July 16, 2018 | 10MG, 15MG, 2.5MG, 20MG, 5MG, 7.5MG |
| SUNSHINE LAKE PHARMA CO LTD | 206238 | AB (A-rated, therapeutically equivalent) | November 19, 2018 | 10MG, 15MG, 2.5MG, 20MG, 5MG, 7.5MG |
| EUGIA PHARMA SPECIALITIES LTD | 210968 | AP (A-rated, therapeutically equivalent) | October 22, 2020 | 10MG/VIAL |
| CADILA PHARMACEUTICALS LTD | 210022 | AB (A-rated, therapeutically equivalent) | February 24, 2023 | 10MG, 15MG, 2.5MG, 20MG, 5MG, 7.5MG |
| ASPIRO PHARMA LTD | 217466 | AP (A-rated, therapeutically equivalent) | March 22, 2023 | 10MG/VIAL |
| QILU PHARMACEUTICAL CO LTD | 218116 | AP (A-rated, therapeutically equivalent) | May 16, 2025 | 10MG/VIAL |
| UBI PHARMA INC | 211072 | AP (A-rated, therapeutically equivalent) | June 11, 2025 | 10MG/VIAL |
| OMNIVIUM PHARMACEUTICALS LLC | 219048 | AP (A-rated, therapeutically equivalent) | January 23, 2026 | 10MG/VIAL |
| ADAPTIS PHARMA PRIVATE LTD | 220323 | AP (A-rated, therapeutically equivalent) | March 5, 2026 | 10MG/VIAL |
Zyprexa NDC codes
Questions
Is there a generic for Zyprexa?
Yes. The generic name for Zyprexa is olanzapine. 19 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
What is the generic name for Zyprexa?
The active ingredient in Zyprexa 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.
More on Zyprexa and Olanzapine
- What is Olanzapine used for?FDA label uses
- Is Olanzapine a controlled substance?Federal schedule
- Generic for Zyprexa RelprevvFDA Orange Book
- Generic for Zyprexa ZydisFDA Orange Book
- Atypical Antipsychotics listFDA drug class
- NDC 61269-630Zyprexa NDC record
- NDC 61269-631Zyprexa NDC record
- NDC 61269-632Zyprexa NDC record