FDA Orange Book · active-ingredient family
Capecitabine
Capecitabine: 1 brand, 14 generics; first approved Apr 30, 1998; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 14 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
14
Listed patents
0
Presentations
30
Brand (NDA) products
Originator applications
- XELODARLDCHEPLAPHARMNDA 02089619982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued —
Generic (ANDA) products (14)
Abbreviated applications
- CAPECITABINEHETERO LABS LTD VANDA 21020320242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - CAPECITABINETEYRO LABSANDA 21723720232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Rx BX 500MG TABLET ORAL Rx BX - CAPECITABINEDR REDDYSANDA 20434520202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - CAPECITABINERELIANCE LIFEANDA 21172420202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - CAPECITABINESUN PHARMANDA 20466820192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — - CAPECITABINEMSNANDA 20936520182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - CAPECITABINEEUGIA PHARMAANDA 21060420182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - CAPECITABINEALKEM LABS LTDANDA 20765220172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - CAPECITABINEAMNEAL PHARMSANDA 20474120172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — - CAPECITABINESHILPAANDA 20745620162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - CAPECITABINEHIKMAANDA 20048320162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Discontinued — 500MG TABLET ORAL Discontinued — - CAPECITABINEACCORD HLTHCAREANDA 20259320152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - CAPECITABINERISINGANDA 09094320142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB - CAPECITABINETEVA PHARMS USAANDA 09164920132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Rx AB 500MG TABLET ORAL Rx AB
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
28 yr 8 mo ago
Most recent approval
2 yr 6 mo ago
Approvals span 1998–2024 across 15 FDA applications.
Brand (NDA) 17%
Generic (ANDA) 1493%
Capecitabine: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
