Medicine
Dutasteride 0.5 mg capsule
Dutasteride 0.5 mg capsule is a generic prescription medicine for oral use, made by 13 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 25°C (77°F), excursions permitted to 15º to 30ºC (59º to 86ºF).
Key facts
- Active ingredient (INN)
- Dutasteride
- Brand
- Sold under the generic name
- Strength
- 0.5 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 30 capsules, 90 capsules, 4 bags and 39 more
- Manufacturers
- Marksans PharmaIndiaAurobindo PharmaIndiaCamber PharmaceuticalsIndiaStrides PharmaIndiaBryant Ranch PrepackA-S Medication SolutionsProficient RxNuCare Pharmaceuticals,IncAmneal PharmaceuticalsEpic Pharma13 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15º to 30ºC (59º to 86ºF).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- G04CB02 Dutasteride
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 2 November 2015
- Identifiers
- RxCUI 351172DailyMed set ID 2ad309b1-4497-8b9b-e063-6394a90aa9b4, b32611f3-50ec-45bb-a671-ea10cec7829d, 74f29982-2317-4d31-a324-fe99bd134c31 +19NDC 68071-3757, 59651-021, 63629-1222 +19Application ANDA209909, ANDA202660, ANDA206574 +4
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
A sample of 40 packs from 13 labelers. The register lists 42 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 capsule, liquid filled in 1 bottle | 59651-021-30 | Aurobindo PharmaIndia | 20 January 2023 |
| 90 capsule, liquid filled in 1 bottle | 59651-021-90 | Aurobindo PharmaIndia | 20 January 2023 |
| 30 capsule, liquid filled in 1 bottle | 31722-131-30 | Camber PharmaceuticalsIndia | 7 November 2016 |
| 90 capsule, liquid filled in 1 bottle | 31722-131-90 | Camber PharmaceuticalsIndia | 7 November 2016 |
| 30 capsule, liquid filled in 1 bottle | 25000-011-03 | Marksans PharmaIndia | 27 April 2017 |
| 90 capsule, liquid filled in 1 bottle | 25000-011-07 | Marksans PharmaIndia | 27 April 2017 |
| 4 bag in 1 box / 2500 capsule, liquid filled in 1 bag | 25000-011-27 | Marksans PharmaIndia | 27 April 2017 |
| 30 capsule, liquid filled in 1 bottle, plastic | 64380-763-04 | Strides PharmaIndia | 9 December 2016 |
| 90 capsule, liquid filled in 1 bottle, plastic | 64380-763-05 | Strides PharmaIndia | 10 December 2016 |
| 30 capsule in 1 bottle | 65162-750-03 | Amneal Pharmaceuticals | 2 November 2015 |
| 90 capsule in 1 bottle | 65162-750-09 | Amneal Pharmaceuticals | 2 November 2015 |
| 90 capsule in 1 bottle | 84091-100-90 | Banyan Pharma | 31 December 2025 |
| 90 capsule, liquid filled in 1 bottle | 42806-549-09 | Epic Pharma | 28 November 2017 |
| 30 capsule, liquid filled in 1 bottle | 42806-549-30 | Epic Pharma | 28 November 2017 |
| 30 capsule, liquid filled in 1 bottle | 72865-140-30 | XLCare Pharmaceuticals | 9 March 2020 |
| 90 capsule, liquid filled in 1 bottle | 72865-140-90 | XLCare Pharmaceuticals | 9 March 2020 |
| 90 capsule, liquid filled in 1 bottle | 63629-1222-1 | Bryant Ranch Prepack | 7 November 2016 |
| 30 capsule, liquid filled in 1 bottle | 63629-1223-1 | Bryant Ranch Prepack | 7 November 2016 |
| 30 capsule, liquid filled in 1 bottle | 63629-8207-1 | Bryant Ranch Prepack | 1 August 2019 |
| 90 capsule, liquid filled in 1 bottle | 63629-8207-2 | Bryant Ranch Prepack | 22 July 2020 |
| 180 capsule, liquid filled in 1 bottle | 63629-8207-3 | Bryant Ranch Prepack | 11 April 2022 |
| 60 capsule, liquid filled in 1 bottle | 63629-8207-4 | Bryant Ranch Prepack | 11 April 2022 |
| 30 capsule, liquid filled in 1 bottle | 72162-1296-3 | Bryant Ranch Prepack | 30 August 2023 |
| 90 capsule, liquid filled in 1 bottle | 72162-1296-9 | Bryant Ranch Prepack | 30 August 2023 |
| 60 capsule, liquid filled in 1 bottle | 68071-3732-6 | NuCare Pharmaceuticals | 2 December 2024 |
| 60 capsule, liquid filled in 1 bottle | 68071-3757-6 | NuCare Pharmaceuticals | 3 January 2025 |
| 90 capsule, liquid filled in 1 bottle | 68071-3857-9 | NuCare Pharmaceuticals | 2 June 2025 |
| 90 capsule, liquid filled in 1 bottle | 68071-4821-9 | NuCare Pharmaceuticals,Inc | 26 March 2019 |
| 30 capsule, liquid filled in 1 bottle | 50090-4010-0 | A-S Medication Solutions | 28 December 2018 |
| 90 capsule, liquid filled in 1 bottle | 50090-4010-1 | A-S Medication Solutions | 1 July 2019 |
| 30 capsule, liquid filled in 1 bottle | 50090-7305-0 | A-S Medication Solutions | 14 October 2024 |
| 90 capsule, liquid filled in 1 bottle | 50090-7305-1 | A-S Medication Solutions | 14 October 2024 |
| 30 capsule, liquid filled in 1 bottle | 50090-7852-0 | A-S Medication Solutions | 8 January 2026 |
| 90 capsule, liquid filled in 1 bottle | 50090-7852-1 | A-S Medication Solutions | 8 January 2026 |
| 30 capsule in 1 bottle | 71205-039-30 | Proficient Rx | 1 May 2018 |
| 60 capsule in 1 bottle | 71205-039-60 | Proficient Rx | 1 May 2018 |
| 90 capsule in 1 bottle | 71205-039-90 | Proficient Rx | 1 May 2018 |
| 30 capsule, liquid filled in 1 bottle | 71205-278-30 | Proficient Rx | 1 May 2019 |
| 60 capsule, liquid filled in 1 bottle | 71205-278-60 | Proficient Rx | 1 May 2019 |
| 90 capsule, liquid filled in 1 bottle | 71205-278-90 | Proficient Rx | 1 May 2019 |
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 20 November 2001 | 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
Dutasteride is a 5-alpha reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, among other approved uses. It is available as capsules for oral use. MedsAcross supplies Dutasteride 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 DutasterideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Dutasteride prescribing information (Strides Pharma) · U.S. National Library of Medicine, DailyMed
Need Dutasteride 0.5 mg capsule 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.