FDA Orange Book
Generic for Xeloda
Xeloda contains capecitabine. 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 Xeloda is capecitabine. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, BX.
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Xeloda products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 150MG | Discontinued | None | 11 | AB, BX |
| tablet, oral | 500MG | Discontinued | None | 11 | AB, BX |
NDA 020896, held by CHEPLAPHARM ARZNEIMITTEL GMBH. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic capecitabine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 091649 | AB (A-rated, therapeutically equivalent) | September 16, 2013 | 150MG, 500MG |
| RISING PHARMA HOLDING INC | 090943 | AB (A-rated, therapeutically equivalent) | August 8, 2014 | 150MG, 500MG |
| ACCORD HEALTHCARE INC | 202593 | AB (A-rated, therapeutically equivalent) | April 23, 2015 | 150MG, 500MG |
| SHILPA MEDICARE LTD | 207456 | AB (A-rated, therapeutically equivalent) | December 12, 2016 | 150MG, 500MG |
| ALKEM LABORATORIES LTD | 207652 | AB (A-rated, therapeutically equivalent) | November 24, 2017 | 150MG, 500MG |
| EUGIA PHARMA SPECIALITIES LTD | 210604 | AB (A-rated, therapeutically equivalent) | April 17, 2018 | 150MG, 500MG |
| MSN LABORATORIES PRIVATE LTD | 209365 | AB (A-rated, therapeutically equivalent) | July 2, 2018 | 150MG, 500MG |
| SOMERSET THERAPEUTICS LLC | 211724 | AB (A-rated, therapeutically equivalent) | April 27, 2020 | 150MG, 500MG |
| DR REDDYS LABORATORIES LTD | 204345 | AB (A-rated, therapeutically equivalent) | December 4, 2020 | 150MG, 500MG |
| TEYRO LABS PRIVATE LTD | 217237 | BX (B-rated, not considered equivalent) | October 23, 2023 | 150MG, 500MG |
| HETERO LABS LTD UNIT V | 210203 | AB (A-rated, therapeutically equivalent) | March 5, 2024 | 150MG, 500MG |
Xeloda NDC codes
Questions
Is there a generic for Xeloda?
Yes. The generic name for Xeloda is capecitabine. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, BX.
What is the generic name for Xeloda?
The active ingredient in Xeloda is capecitabine, 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.