Active ingredient
Capecitabine
36 finished FDA listings contain Capecitabine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- CAPECITABINE
- Dosage forms
- Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 19
- Strengths listed
- 150 mg/1 · 500 mg/1
- Brand names in FDA listings
- Capecitabine 150mg, Capecitabine 500mg, Xeloda
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 194000
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 020896 | CHEPLAPHARM | 1998-04-30 | 1 |
| ANDA 091649 | TEVA PHARMS USA | 2013-09-16 | 5 |
| ANDA 202593 | ACCORD HLTHCARE | 2015-04-23 | 4 |
| ANDA 207456 | SHILPA | 2016-12-12 | 2 |
| ANDA 207652 | ALKEM LABS LTD | 2017-11-27 | 4 |
| ANDA 210604 | EUGIA PHARMA | 2018-04-17 | 2 |
| ANDA 209365 | MSN | 2018-07-02 | 4 |
| ANDA 204668 | SUN PHARM | 2019-06-21 | 2 |
| ANDA 211724 | RELIANCE LIFE | 2020-04-27 | 2 |
| ANDA 204345 | DR REDDYS | 2020-12-04 | 3 |
| ANDA 217237 | TEYRO LABS | 2023-10-23 | 2 |
| ANDA 210203 | HETERO LABS LTD V | 2024-03-05 | 5 |
Official labeling on DailyMed
- CAPECITABINE (CAPECITABINE) TABLET, FILM COATED [NORTHSTAR RXLLC] · version 2 · 2026-07-23
- CAPECITABINE TABLET [AUROBINDO PHARMA LIMITED] · version 7 · 2026-07-22
- CAPECITABINE TABLET [QUALLENT PHARMACEUTICALS HEALTH LLC] · version 3 · 2026-06-23
- CAPECITABINE TABLET, FILM COATED [ASCEND LABORATORIES, LLC] · version 18 · 2026-06-18
- CAPECITABINE (CAPECITABINE) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] · version 3 · 2026-05-13
- CAPECITABINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] · version 5 · 2026-05-11
- CAPECITABINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] · version 14 · 2026-03-05
- CAPECITABINE TABLET [DR. REDDY'S LABORATORIES LIMITED] · version 15 · 2026-03-03
- CAPECITABINE TABLET, FILM COATED [BLUEPOINT LABORATORIES] · version 3 · 2026-02-06
- XELODA (CAPECITABINE) TABLET, FILM COATED [H2-PHARMA, LLC] · version 32 · 2026-02-06
- CAPECITABINE (CAPECITABINE) TABLET, FILM COATED [LIFESTAR PHARMA LLC] · version 8 · 2025-11-17
- CAPECITABINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] · version 9 · 2025-08-22
Showing the 12 most recent of 21 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.