Medicine
Abiraterone 500 mg tablet
Abiraterone 500 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
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
- 500 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 6 blister pack, 60 tablets, 500 tablets and 14 more
- Manufacturers
- Dr. Reddy's LaboratoriesIndiaNovadoz PharmaceuticalsIndiaGlenmark PharmaceuticalsIndiaAmneal PharmaceuticalsAmneal Pharmaceuticals NYApotexAvKAREBluePoint LaboratoriesBryant Ranch PrepackFlorida Pharmaceutical Products
- 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
- 7 January 2019
- Identifiers
- RxCUI 1918042, 1100075DailyMed set ID 68121a71-5024-4f9e-bd9c-2d412f6a6355, f308b463-27e4-422a-95a2-ecbbf95eee20, c1200e4e-c4f7-9067-e053-2a95a90af509 +12NDC 71921-177, 82293-002, 42291-073 +12Application ANDA215086, ANDA215947, ANDA208327 +5
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 |
|---|---|---|---|
| 6 blister pack in 1 carton / 10 tablet in 1 blister pack | 43598-468-38 | Dr. Reddy's LaboratoriesIndia | 11 September 2023 |
| 60 tablet in 1 bottle | 43598-468-60 | Dr. Reddy's LaboratoriesIndia | 11 September 2023 |
| 60 tablet in 1 bottle | 68462-882-60 | Glenmark PharmaceuticalsIndia | 19 May 2022 |
| 500 tablet, film coated in 1 bottle | 72205-285-05 | Novadoz PharmaceuticalsIndia | 24 May 2024 |
| 60 tablet, film coated in 1 bottle | 72205-285-60 | Novadoz PharmaceuticalsIndia | 24 May 2024 |
| 60 tablet in 1 bottle | 60219-1754-6 | Amneal Pharmaceuticals | 28 April 2023 |
| 60 tablet in 1 bottle | 69238-1754-6 | Amneal Pharmaceuticals NY | 7 January 2019 |
| 60 tablet, film coated in 1 bottle | 60505-4764-6 | Apotex | 16 July 2021 |
| 60 tablet, film coated in 1 bottle | 71921-177-06 | Florida Pharmaceutical Products | 10 April 2023 |
| 60 tablet, film coated in 1 bottle, plastic | 0378-6921-91 | Mylan Pharmaceuticals | 14 December 2020 |
| 60 tablet, film coated in 1 bottle, plastic | 82293-002-10 | Novugen Pharma | 5 January 2022 |
| 60 tablet in 1 bottle | 42291-073-60 | AvKARE | 29 April 2021 |
| 60 tablet in 1 bottle | 68001-673-06 | BluePoint Laboratories | 16 October 2025 |
| 60 tablet, film coated in 1 bottle, plastic | 72162-2151-6 | Bryant Ranch Prepack | 7 December 2023 |
| 60 tablet, film coated in 1 bottle, plastic | 51407-989-60 | Golden State Medical Supply | 17 June 2026 |
| 60 tablet in 1 bottle | 72603-111-01 | Northstar RX | 19 May 2022 |
| 60 tablet, film coated in 1 bottle | 82009-140-60 | Quallent Pharmaceuticals Health | 16 July 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.
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 500 mg tablet.
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 AbirateroneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Zytiga prescribing information (Janssen Biotech) · U.S. National Library of Medicine, DailyMed
- Zytiga: European public assessment report (EPAR) · European Medicines Agency
- Abiraterone Accord: European public assessment report (EPAR) · European Medicines Agency
Need Abiraterone 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.