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Medicine

Colchicine 0.6 mg tablet

Colchicine · Oral
Available on requestPrescription onlyUS FDAGeneric name

Colchicine 0.6 mg tablet is a generic prescription medicine for oral use, made by 23 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). Protect from light.

Key facts

Active ingredient (INN)
Colchicine
Brand
Sold under the generic name
Strength
0.6 mg
Dosage form
Tablet
Route
Oral
Packs
100 tablets, 500 tablets, 1000 tablets and 86 more
Manufacturers
Ascend LaboratoriesIndiaMacleods PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaGranules IndiaIndiaAurobindo PharmaIndiaCamber PharmaceuticalsIndiaBryant Ranch PrepackAmneal PharmaceuticalsChartwell RXPar Health23 labelers on the register
Origin register
US FDA, United States
Storage
Store at 20° to 25°C (68° to 77°F). Protect from light.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
M04AC01 Colchicine
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
30 September 2016
Identifiers
RxCUI 197541DailyMed set ID 7daef7e2-888d-4116-81a9-2c02b9ef97ef, a4284783-fea6-4af2-9a8d-79c929176c05, ac12e420-9f29-018e-e053-2a95a90ab612 +30NDC 65162-710, 67877-589, 51407-082 +30Application ANDA204711, ANDA211250, ANDA210425 +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

A sample of 40 packs from 23 labelers. The register lists 89 packs for this generic presentation, and we confirm the exact pack on the quote.

PackCodeLabelerMarketed since
100 tablet in 1 bottle67877-589-01Ascend LaboratoriesIndia10 February 2019
500 tablet in 1 bottle67877-589-05Ascend LaboratoriesIndia10 February 2019
1000 tablet in 1 bottle67877-589-10Ascend LaboratoriesIndia10 February 2019
30 tablet in 1 bottle67877-589-30Ascend LaboratoriesIndia10 February 2019
1 blister pack in 1 carton / 10 tablet in 1 blister pack67877-589-33Ascend LaboratoriesIndia10 February 2019
60 tablet in 1 bottle67877-589-60Ascend LaboratoriesIndia10 February 2019
3 blister pack in 1 carton / 10 tablet in 1 blister pack67877-589-84Ascend LaboratoriesIndia10 February 2019
250 tablet in 1 bottle67877-589-86Ascend LaboratoriesIndia10 February 2019
100 tablet in 1 bottle59651-455-01Aurobindo PharmaIndia22 March 2022
30 tablet in 1 bottle59651-455-30Aurobindo PharmaIndia22 March 2022
100 tablet, film coated in 1 bottle31722-899-01Camber PharmaceuticalsIndia13 August 2021
30 tablet, film coated in 1 bottle31722-899-30Camber PharmaceuticalsIndia13 August 2021
100 tablet in 1 bottle43598-372-01Dr. Reddy's LaboratoriesIndia11 June 2020
1000 tablet in 1 bottle43598-372-10Dr. Reddy's LaboratoriesIndia4 September 2020
30 tablet in 1 bottle43598-372-30Dr. Reddy's LaboratoriesIndia11 June 2020
100 tablet, film coated in 1 bottle70010-002-01Granules IndiaIndia13 May 2020
30 tablet, film coated in 1 bottle70010-002-03Granules IndiaIndia13 May 2020
1000 tablet, film coated in 1 bottle70010-002-10Granules IndiaIndia13 May 2023
30 tablet in 1 bottle33342-341-07Macleods PharmaceuticalsIndia23 August 2018
100 tablet in 1 bottle33342-341-11Macleods PharmaceuticalsIndia23 August 2018
500 tablet in 1 bottle33342-341-15Macleods PharmaceuticalsIndia23 August 2018
11 blister pack in 1 carton / 10 tablet in 1 blister pack33342-341-42Macleods PharmaceuticalsIndia23 August 2018
30 tablet in 1 bottle65162-710-03Amneal Pharmaceuticals30 September 2016
90 tablet in 1 bottle65162-710-09Amneal Pharmaceuticals30 September 2016
1000 tablet in 1 bottle65162-710-11Amneal Pharmaceuticals30 September 2016
30 tablet, film coated in 1 bottle62135-789-30Chartwell RX27 October 2023
90 tablet, film coated in 1 bottle62135-789-90Chartwell RX27 October 2023
100 tablet, film coated in 1 bottle, plastic0378-1086-01Mylan Pharmaceuticals25 November 2019
100 tablet, film coated in 1 bottle49884-171-01Par Health27 September 2022
30 tablet, film coated in 1 bottle49884-171-11Par Health27 September 2022
100 tablet, film coated in 1 bottle, plastic63629-2166-1Bryant Ranch Prepack1 July 2018
30 tablet, film coated in 1 bottle, plastic63629-2167-1Bryant Ranch Prepack1 July 2018
30 tablet in 1 bottle63629-8362-1Bryant Ranch Prepack16 November 2020
20 tablet in 1 bottle63629-8362-2Bryant Ranch Prepack1 September 2022
3 tablet in 1 bottle63629-8362-3Bryant Ranch Prepack1 September 2022
12 tablet in 1 bottle63629-8362-4Bryant Ranch Prepack1 September 2022
6 tablet in 1 bottle63629-8362-5Bryant Ranch Prepack1 September 2022
9 tablet in 1 bottle63629-8362-6Bryant Ranch Prepack1 September 2022
15 tablet in 1 bottle63629-8362-7Bryant Ranch Prepack1 September 2022
10 tablet in 1 bottle63629-8362-8Bryant Ranch Prepack1 September 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 29 July 2009Drugs@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

Alternatives

Other makers and brands of Colchicine 0.6 mg tablet.

Compare 1

Other strengths and forms of Colchicine

Clinical summary

Colchicine is an alkaloid indicated for prophylaxis of gout flares in adults, among other approved uses. It is available as tablets, capsules and oral solution. MedsAcross supplies Colchicine 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 Colchicine

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

Data sources

Need Colchicine 0.6 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.