Medicine
Bicalutamide 50 mg tablet
Bicalutamide 50 mg tablet is a generic prescription medicine for oral use, made by 8 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). ”
Key facts
- Active ingredient (INN)
- Bicalutamide
- Brand
- Sold under the generic name
- Strength
- 50 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 30 tablets, 1000 tablets and 15 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaAccord HealthcareIndiaPinnacle Life ScienceIndiaViona PharmaceuticalsIndiaProficient RxBryant Ranch PrepackANI PharmaceuticalsGolden State Medical Supply
- 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
- L02BB03 Bicalutamide
- HS code (indicative)
- 3004.39Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 4 October 1995
- Identifiers
- RxCUI 199123DailyMed set ID 7c295b64-ec39-42ec-9f02-da5b42e775e1, 5a7cbe80-f119-4b3d-949a-c7824ea91908, 10e21544-f181-4cf8-9824-df0f49d19511 +6NDC 16729-023, 72578-215, 82804-082 +6Application ANDA078917, ANDA079089, ANDA079110 +1
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 |
|---|---|---|---|
| 100 tablet in 1 bottle | 16729-023-01 | Accord HealthcareIndia | 6 July 2009 |
| 30 tablet in 1 bottle | 16729-023-10 | Accord HealthcareIndia | 6 July 2009 |
| 100 tablet in 1 bottle | 84508-001-01 | Pinnacle Life ScienceIndia | 7 June 2009 |
| 30 tablet in 1 bottle | 84508-001-30 | Pinnacle Life ScienceIndia | 7 June 2009 |
| 100 tablet, film coated in 1 bottle | 47335-485-08 | Sun Pharmaceutical IndustriesIndia | 15 December 2014 |
| 1000 tablet, film coated in 1 bottle | 47335-485-18 | Sun Pharmaceutical IndustriesIndia | 15 December 2014 |
| 30 tablet, film coated in 1 bottle | 47335-485-83 | Sun Pharmaceutical IndustriesIndia | 15 December 2014 |
| 100 tablet, film coated in 1 bottle | 47335-485-88 | Sun Pharmaceutical IndustriesIndia | 15 December 2014 |
| 100 tablet in 1 bottle | 72578-215-01 | Viona PharmaceuticalsIndia | 7 June 2009 |
| 30 tablet in 1 bottle | 72578-215-06 | Viona PharmaceuticalsIndia | 7 June 2009 |
| 30 tablet in 1 bottle | 62559-890-30 | ANI Pharmaceuticals | 26 October 2020 |
| 30 tablet in 1 bottle | 71205-577-30 | Proficient Rx | 9 June 2021 |
| 60 tablet in 1 bottle | 71205-577-60 | Proficient Rx | 9 June 2021 |
| 90 tablet in 1 bottle | 71205-577-90 | Proficient Rx | 9 June 2021 |
| 90 tablet, film coated in 1 bottle | 82804-082-90 | Proficient Rx | 13 March 2024 |
| 30 tablet in 1 bottle | 63629-8308-1 | Bryant Ranch Prepack | 8 June 2021 |
| 100 tablet in 1 bottle | 63629-8308-2 | Bryant Ranch Prepack | 16 March 2020 |
| 30 tablet in 1 bottle | 51407-010-30 | Golden State Medical Supply | 30 September 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 4 October 1995 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US 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 Bicalutamide 50 mg tablet.
Clinical summary
Bicalutamide is an androgen receptor inhibitor indicated in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate, among other approved uses. MedsAcross supplies Bicalutamide 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 BicalutamideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Bicalutamide prescribing information (ANI Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Bicalutamide 50 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.