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Medicine

Abiraterone 250 mg tablet

Abiraterone · Oral
Available on requestPrescription onlyUS FDAGeneric name

Abiraterone 250 mg tablet is a generic prescription medicine for oral use, made by 20 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°C to 25°C (68°F to 77°F), excursions permitted in the range from…

Key facts

Active ingredient (INN)
Abiraterone
Brand
Sold under the generic name
Strength
250 mg
Dosage form
Tablet
Route
Oral
Packs
120 tablets, 3 blister pack, 500 tablets and 22 more
Manufacturers
Dr. Reddy's LaboratoriesIndiaNovadoz PharmaceuticalsIndiaGlenmark PharmaceuticalsIndiaNorthStar RxAmerican Health PackagingAmneal PharmaceuticalsAmneal Pharmaceuticals NYApotexAvKAREAvPAK
Origin register
US FDA, United States
Storage
Store at 20°C to 25°C (68°F to 77°F), excursions permitted in the range from 15°C to 30°C (59°F to 86°F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
L02BX03 Abiraterone
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
21 November 2018
Identifiers
RxCUI 1100075, 1918042DailyMed set ID 6f5b628b-69da-4a04-a4d5-623b18d1fd5d, 2ac063f0-4177-c90f-27c3-e70e29689255, 7f82d549-6654-1efd-e053-2991aa0aa28d +19NDC 82009-139, 60505-4327, 42291-024 +20Application ANDA210686, ANDA208453, ANDA208327 +7

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
120 tablet in 1 bottle43598-358-04Dr. Reddy's LaboratoriesIndia19 May 2020
3 blister pack in 1 carton / 10 tablet in 1 blister pack43598-358-31Dr. Reddy's LaboratoriesIndia20 December 2021
120 tablet in 1 bottle75907-224-04Dr. Reddy's LaboratoriesIndia17 March 2025
120 tablet in 1 bottle72205-030-92Novadoz PharmaceuticalsIndia10 July 2019
500 tablet, film coated in 1 bottle72205-284-05Novadoz PharmaceuticalsIndia24 May 2024
120 tablet, film coated in 1 bottle72205-284-92Novadoz PharmaceuticalsIndia24 May 2024
120 tablet in 1 bottle68462-135-08Glenmark PharmaceuticalsIndia16 October 2019
120 tablet in 1 bottle60219-1165-7Amneal Pharmaceuticals28 April 2023
120 tablet in 1 bottle69238-1165-7Amneal Pharmaceuticals NY7 January 2019
120 tablet in 1 bottle60505-4327-1Apotex23 November 2018
120 tablet in 1 bottle, plastic82249-010-12CivicaScript27 June 2022
120 tablet in 1 bottle71921-178-20Florida Pharmaceutical Products15 August 2022
120 tablet in 1 bottle0143-9597-21Hikma Pharmaceuticals23 November 2018
120 tablet in 1 bottle, plastic0378-6920-78Mylan Pharmaceuticals21 November 2018
120 tablet, film coated in 1 bottle, plastic82293-001-10Novugen Pharma5 January 2022
120 tablet in 1 bottle64980-418-12Rising Pharma Holdings25 February 2019
120 tablet in 1 bottle16714-963-01NorthStar Rx19 May 2020
120 tablet in 1 bottle72603-110-01Northstar RX7 March 2022
30 blister pack in 1 carton / 1 tablet in 1 blister pack60687-790-21American Health Packaging31 July 2024
120 tablet in 1 bottle42291-024-12AvKARE14 January 2019
20 blister pack in 1 box / 1 tablet in 1 blister pack50268-032-12AvPAK4 May 2026
120 tablet in 1 bottle68001-489-07BluePoint Laboratories26 February 2021
30 blister pack in 1 carton / 1 tablet in 1 blister pack0904-6948-04Major Pharmaceuticals23 November 2018
120 tablet in 1 bottle, plastic72789-213-98PD-Rx Pharmaceuticals11 October 2021
120 tablet in 1 bottle82009-139-12Quallent Pharmaceuticals Health15 June 2024

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 28 April 2011Drugs@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 Abiraterone 250 mg tablet.

Compare all 2

Other strengths and forms of Abiraterone

Clinical summary

Abiraterone is a cytochrome P450 17A1 inhibitor. It is available as tablets for oral use. MedsAcross supplies Abiraterone 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 Abiraterone

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

Data sources

Need Abiraterone 250 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.