Medicine
Nubeqa 300 mg tablet
Nubeqa 300 mg tablet is a prescription medicine containing Darolutamide for oral use, marketed by Bayer HealthCare Pharmaceuticals, 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 between 15°C and…
Key facts
- Active ingredient (INN)
- Darolutamide
- Brand
- Nubeqa
- Strength
- 300 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1 bottle
- Marketing authorisation holder
- Bayer HealthCare Pharmaceuticals
- Manufacturer
- Bayer HealthCare Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L02BB Hormonal cancer treatments, subgroup L02B, subgroup L02BB
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 31 July 2019
- Identifiers
- RxCUI 2180330, 2180336DailyMed set ID 1a7cb212-56e4-4b9d-a73d-bfee7fe4735eNDC 50419-395Application NDA212099
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 |
|---|---|---|---|
| 1 bottle in 1 carton / 120 tablet, film coated in 1 bottle | 50419-395-01 | Bayer HealthCare Pharmaceuticals | 31 July 2019 |
| 1 bottle in 1 carton / 120 tablet, film coated in 1 bottle | 50419-395-72 | Bayer HealthCare Pharmaceuticals | 3 March 2021 |
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
Clinical summary
Darolutamide is a prescription medicine indicated for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC). It is available as tablets for oral use. MedsAcross supplies Darolutamide 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 DarolutamideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- NUBEQA prescribing information (Bayer HealthCare Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Nubeqa: European public assessment report (EPAR) · European Medicines Agency
Need Nubeqa 300 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.