Medicine
Nilutamide 150 mg tablet
Nilutamide 150 mg tablet is a generic prescription medicine for oral use, 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 25°C (77°F), excursions permitted between 15 to 30°C (59 to 86°F)…
Key facts
- Active ingredient (INN)
- Nilutamide
- Brand
- Sold under the generic name
- Strength
- 150 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 3 blister pack
- Manufacturer
- ANI Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted between 15 to 30°C (59 to 86°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L02BB02 Nilutamide
- HS code (indicative)
- 3004.39Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 18 July 2016
- Identifiers
- RxCUI 311982DailyMed set ID d5740b8f-fbb3-4023-9133-9e359a9ab980NDC 62559-173Application ANDA207631
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 3 blister pack in 1 carton / 10 tablet in 1 blister pack | 62559-173-31 | ANI Pharmaceuticals | 18 July 2016 |
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 19 September 1996 | 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
Clinical summary
Nilutamide is an androgen receptor inhibitor indicated in combination with surgical castration for the treatment of metastatic prostate cancer (Stage D 2 ). It is available as tablets for oral use. MedsAcross supplies Nilutamide 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 NilutamideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Nilutamide prescribing information (ANI Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Nilutamide 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.