FDA Orange Book
Generic for Temodar
Temodar contains temozolomide. 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 Temodar is temozolomide. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 6 of the 7 Temodar products the Orange Book lists.
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Temodar products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 100MG | Discontinued | None | 10 | AB |
| capsule, oral | 140MG | Discontinued | None | 10 | AB |
| capsule, oral | 180MG | Discontinued | None | 10 | AB |
| capsule, oral | 20MG | Discontinued | None | 9 | AB |
| capsule, oral | 250MG | Discontinued | None | 10 | AB |
| capsule, oral | 5MG | Discontinued | None | 9 | AB |
| powder, intravenous | 100MG/VIAL | Marketed (Rx) | None | 0 | None |
NDA 021029, 022277, held by MERCK SHARP AND DOHME CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic temozolomide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SUN PHARMACEUTICAL INDUSTRIES LTD | 201742 | AB (A-rated, therapeutically equivalent) | February 12, 2014 | 100MG, 140MG, 180MG, 20MG, 250MG, 5MG |
| AMNEAL PHARMACEUTICALS | 203691 | AB (A-rated, therapeutically equivalent) | May 8, 2015 | 100MG, 140MG, 180MG, 20MG, 250MG, 5MG |
| EIRGEN PHARMA LTD | 203898 | AB (A-rated, therapeutically equivalent) | February 10, 2016 | 100MG, 140MG, 180MG, 250MG |
| CHARTWELL LIFE MOLECULES LLC | 206413 | AB (A-rated, therapeutically equivalent) | April 12, 2016 | 100MG, 140MG, 180MG, 20MG, 250MG, 5MG |
| RISING PHARMA HOLDINGS INC | 206309 | AB (A-rated, therapeutically equivalent) | April 27, 2016 | 100MG, 140MG, 180MG, 20MG, 250MG, 5MG |
| CHEMI SPA | 204639 | AB (A-rated, therapeutically equivalent) | November 23, 2016 | 100MG, 140MG, 180MG, 20MG, 250MG, 5MG |
| ACCORD HEALTHCARE INC | 201528 | AB (A-rated, therapeutically equivalent) | February 27, 2017 | 100MG, 140MG, 180MG, 20MG, 250MG, 5MG |
| DEVA HOLDING AS | 207658 | AB (A-rated, therapeutically equivalent) | April 26, 2017 | 100MG, 140MG, 180MG, 20MG, 250MG, 5MG |
| ZYDUS PHARMACEUTICALS USA INC | 206750 | AB (A-rated, therapeutically equivalent) | July 31, 2017 | 100MG, 140MG, 180MG, 20MG, 250MG, 5MG |
| HETERO LABS LTD UNIT V | 210030 | AB (A-rated, therapeutically equivalent) | August 23, 2024 | 100MG, 140MG, 180MG, 20MG, 250MG, 5MG |
Temodar NDC codes
Questions
Is there a generic for Temodar?
Yes. The generic name for Temodar is temozolomide. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 6 of the 7 Temodar products the Orange Book lists.
What is the generic name for Temodar?
The active ingredient in Temodar is temozolomide, 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.