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Medicine

Capecitabine 150 mg tablet

Capecitabine · Oral
Available on requestPrescription onlyUS FDAGeneric name

Capecitabine 150 mg tablet is a generic prescription medicine for oral use, made by 15 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

Available on request

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).

Key facts

Active ingredient (INN)
Capecitabine
Brand
Sold under the generic name
Strength
150 mg
Dosage form
Tablet
Route
Oral
Packs
60 tablets, 120 tablets, 30 tablets and 18 more
Manufacturers
Ascend LaboratoriesIndiaSun Pharmaceutical IndustriesIndiaAurobindo PharmaIndiaDr. Reddy's LaboratoriesIndiaAccord HealthcareIndiaCamber PharmaceuticalsIndiaCiplaIndiaLifestar PharmaIndiaNovadoz PharmaceuticalsIndiaTeyro LabsIndia
Origin register
US FDA, United States
Storage
Store at 20° to 25°C (68° to 77°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 5753679a-506c-4ac4-b8b2-b27c664d1d40, 643a31d6-0e30-4602-a9b4-355fe944bfea, 29885ada-b743-419c-8f15-edd4247c76ca +12NDC 0093-7473, 70756-815, 72205-006 +12Application ANDA091649, ANDA211724, ANDA209365 +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.

PackCodeLabelerMarketed since
60 tablet, film coated in 1 bottle, plastic16729-072-12Accord HealthcareIndia9 June 2015
120 tablet, film coated in 1 bottle67877-458-12Ascend LaboratoriesIndia25 November 2017
30 tablet, film coated in 1 bottle67877-458-30Ascend LaboratoriesIndia25 November 2017
60 tablet, film coated in 1 bottle67877-458-60Ascend LaboratoriesIndia1 May 2019
1 blister pack in 1 carton / 10 tablet in 1 blister pack59651-204-10Aurobindo PharmaIndia17 April 2018
60 tablet in 1 bottle59651-204-60Aurobindo PharmaIndia17 April 2018
60 tablet, film coated in 1 bottle31722-774-60Camber PharmaceuticalsIndia5 March 2024
60 tablet, film coated in 1 bottle69097-949-03CiplaIndia1 July 2023
500 tablet in 1 bottle55111-496-05Dr. Reddy's LaboratoriesIndia10 December 2020
60 tablet in 1 bottle55111-496-60Dr. Reddy's LaboratoriesIndia10 December 2020
60 tablet, film coated in 1 bottle, plastic70756-815-60Lifestar PharmaIndia1 September 2020
60 tablet, film coated in 1 bottle72205-006-60Novadoz PharmaceuticalsIndia21 July 2018
1000 tablet, film coated in 1 bottle62756-238-18Sun Pharmaceutical IndustriesIndia1 September 2019
60 tablet, film coated in 1 bottle62756-238-86Sun Pharmaceutical IndustriesIndia1 September 2019
100 tablet, film coated in 1 bottle62756-238-88Sun Pharmaceutical IndustriesIndia1 September 2019
60 tablet, film coated in 1 bottle, plastic82511-001-15Teyro LabsIndia1 September 2022
1 bottle in 1 carton / 60 tablet, film coated in 1 bottle72485-204-60Armas Pharmaceuticals1 March 2019
60 tablet, film coated in 1 bottle82249-207-60CivicaScript26 June 2025
60 tablet, film coated in 1 bottle0093-7473-06Teva Pharmaceuticals7 March 2014
60 tablet, film coated in 1 bottle68001-643-06BluePoint Laboratories18 April 2025
60 tablet, film coated in 1 bottle51407-639-60Golden State Medical Supply28 June 2022

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 30 April 1998Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

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

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 Capecitabine

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Capecitabine 150 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.