Medicine
Capecitabine 500 mg tablet
Capecitabine 500 mg tablet is a generic prescription medicine for oral use, made by 18 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Capecitabine
- Brand
- Sold under the generic name
- Strength
- 500 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 120 tablets, 30 tablets, 60 tablets and 22 more
- Manufacturers
- Ascend LaboratoriesIndiaSun Pharmaceutical IndustriesIndiaAurobindo PharmaIndiaCamber PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaAccord HealthcareIndiaCiplaIndiaLifestar PharmaIndiaNovadoz PharmaceuticalsIndiaTeyro LabsIndia
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01BC06 Capecitabine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 16 September 2013
- Identifiers
- RxCUI 200327, 200328DailyMed set ID 4ec2cfc1-e8ca-4109-8b90-1aab07cbab21, f050d16c-ab76-489d-b92c-8c155b4e3f7c, e3b1a2b5-f1ce-45ea-afd8-68aac53665fa +15NDC 82249-210, 72485-205, 62756-239 +15Application ANDA207652, ANDA207456, ANDA204668 +8
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 120 tablet, film coated in 1 bottle, plastic | 16729-073-29 | Accord HealthcareIndia | 20 May 2015 |
| 120 tablet, film coated in 1 bottle | 67877-459-12 | Ascend LaboratoriesIndia | 1 May 2019 |
| 30 tablet, film coated in 1 bottle | 67877-459-30 | Ascend LaboratoriesIndia | 25 November 2017 |
| 60 tablet, film coated in 1 bottle | 67877-459-60 | Ascend LaboratoriesIndia | 25 November 2017 |
| 120 tablet in 1 bottle | 59651-205-08 | Aurobindo PharmaIndia | 17 April 2018 |
| 1 blister pack in 1 carton / 10 tablet in 1 blister pack | 59651-205-10 | Aurobindo PharmaIndia | 17 April 2018 |
| 120 tablet, film coated in 1 bottle | 31722-775-12 | Camber PharmaceuticalsIndia | 5 March 2024 |
| 60 tablet, film coated in 1 bottle | 31722-775-60 | Camber PharmaceuticalsIndia | 19 April 2024 |
| 120 tablet, film coated in 1 bottle | 69097-948-08 | CiplaIndia | 1 July 2023 |
| 120 tablet in 1 bottle | 55111-497-04 | Dr. Reddy's LaboratoriesIndia | 10 December 2020 |
| 500 tablet in 1 bottle | 55111-497-05 | Dr. Reddy's LaboratoriesIndia | 10 December 2020 |
| 120 tablet, film coated in 1 bottle, plastic | 70756-816-22 | Lifestar PharmaIndia | 1 September 2020 |
| 120 tablet, film coated in 1 bottle | 72205-007-92 | Novadoz PharmaceuticalsIndia | 21 July 2018 |
| 1000 tablet, film coated in 1 bottle | 62756-239-18 | Sun Pharmaceutical IndustriesIndia | 1 September 2019 |
| 120 tablet, film coated in 1 bottle | 62756-239-20 | Sun Pharmaceutical IndustriesIndia | 1 September 2019 |
| 30 tablet, film coated in 1 bottle | 62756-239-83 | Sun Pharmaceutical IndustriesIndia | 1 September 2019 |
| 120 tablet, film coated in 1 bottle, plastic | 82511-002-50 | Teyro LabsIndia | 16 February 2022 |
| 1 bottle in 1 carton / 120 tablet, film coated in 1 bottle | 72485-205-12 | Armas Pharmaceuticals | 1 March 2019 |
| 120 tablet, film coated in 1 bottle | 82249-210-12 | CivicaScript | 26 June 2025 |
| 120 tablet, film coated in 1 bottle | 0093-7474-89 | Teva Pharmaceuticals | 7 March 2014 |
| 20 blister pack in 1 box, unit-dose / 1 tablet, film coated in 1 blister pack | 60687-149-94 | American Health Packaging | 7 March 2016 |
| 120 tablet, film coated in 1 bottle | 68001-644-07 | BluePoint Laboratories | 22 April 2025 |
| 120 tablet, film coated in 1 bottle | 51407-640-12 | Golden State Medical Supply | 28 June 2022 |
| 120 tablet, film coated in 1 bottle | 72603-303-01 | NorthStar RxLLC | 1 December 2024 |
| 120 tablet in 1 bottle | 82009-112-12 | Quallent Pharmaceuticals Health | 21 July 2023 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Capecitabine 500 mg tablet.
Other strengths and forms of Capecitabine
Clinical summary
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, among other approved uses. MedsAcross supplies Capecitabine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about CapecitabineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- XELODA prescribing information (H2-Pharma) · U.S. National Library of Medicine, DailyMed
- Xeloda: European public assessment report (EPAR) · European Medicines Agency
- Capecitabine Accord: European public assessment report (EPAR) · European Medicines Agency
Need Capecitabine 500 mg tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.