Quick answers
- What is Capecitabine used for?
- The FDA-approved label (Xeloda, H2-Pharma, LLC, February 5, 2026) says: “XELODA (capecitabine) is a nucleoside metabolic inhibitor indicated for: Colorectal Cancer adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen. perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Capecitabine have a boxed warning?
- Yes. The FDA label for Xeloda has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Capecitabine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Capecitabine been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started December 21, 2015 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Capecitabine?
- 19 companies list prescription products of Capecitabine in the FDA NDC Directory, including Teyro Labs Private Limited, Accord Healthcare Inc. and Teva Pharmaceuticals USA, Inc..
What Capecitabine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
XELODA (capecitabine) is a nucleoside metabolic inhibitor indicated for: Colorectal Cancer adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen. perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy. …
— FDA label: Xeloda, H2-Pharma, LLC, effective February 5, 2026. Read the full label on DailyMed →
The FDA has 20 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
20 of 20 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 34 in the FDA NDC Directory |
| Brand names | Xeloda |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| capecitabine 150 mg tablet | Generic | $0.3615 per tablet |
| capecitabine 150 mg tablet, film coated | Generic | $0.3615 per tablet |
| capecitabine 500 mg tablet | Generic | $0.4538 per tablet |
| capecitabine 500 mg tablet, film coated | Generic | $0.4538 per tablet |
NADAC list of November 4, 2026; these prices took effect between June 17, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Teyro Labs Private Limited2 products
- Accord Healthcare Inc.2 products
- Teva Pharmaceuticals USA, Inc.2 products
- Camber Pharmaceuticals, Inc.2 products
- Cipla USA Inc.2 products
- Golden State Medical Supply, Inc.2 products
- Dr. Reddy's Laboratories Limited2 products
- Armas Pharmaceuticals Inc.2 products
- Ascend Laboratories, LLC2 products
- CivicaScript LLC2 products
- Sun Pharmaceutical Industries, Inc.2 products
- BluePoint Laboratories2 products
- Lifestar Pharma LLC2 products
- Novadoz Pharmaceuticals LLC2 products
- Aurobindo Pharma Limited2 products
- American Health Packaging1 product
- Quallent Pharmaceuticals Health LLC1 product
- H2-Pharma, LLC1 product
- NorthStar RxLLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020896 XELODA | Cheplapharm | April 30, 1998 | 32, latest October 3, 2025 2025: Labeling · 2022: Efficacy · 2022: Efficacy |
Generic approvals (11)
- ANDA091649Teva Pharms USA · September 16, 2013
- ANDA202593Accord Hlthcare · April 23, 2015
- ANDA207456Shilpa · December 12, 2016
- ANDA207652Alkem Labs Ltd · November 27, 2017
- ANDA210604Eugia Pharma · April 17, 2018
- ANDA209365Msn · July 2, 2018
- ANDA204668Sun Pharm · June 21, 2019
- ANDA211724Somerset Theraps LLC · April 27, 2020
- ANDA204345DR Reddys · December 4, 2020
- ANDA217237Teyro Labs · October 23, 2023
- ANDA210203Hetero Labs Ltd V · March 5, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
December 21, 2015 · Class II · Terminated · D-0732-2016
Failed Dissolution Specifications: low test results at the 18 month time-point
Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured in Czech Republic by: Teva Czech Industries sro, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, P — Teva North America
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 200327, 200328, 213292, 213293 |
|---|---|
| SPL set ID of the quoted label | e702d84d-7162-4751-bf37-d724cc7e45a5 |
| FDA labels (SPL) | 20 |
| FDA applications | NDA020896, 11 ANDA |
| Active ingredients (FDA) | CAPECITABINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Xeloda, H2-Pharma, LLC, effective February 5, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →