Medicine
Dutasteride and Tamsulosin 0.5 mg/0.4 mg capsule
Dutasteride and Tamsulosin 0.5 mg/0.4 mg capsule is a generic prescription medicine for oral use, made by 2 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)
- Dutasteride and Tamsulosin
- Brand
- Sold under the generic name
- Strength
- 0.5 mg/0.4 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 30 capsules, 90 capsules and 3 more
- Manufacturers
- Zydus LifesciencesIndiaAurobindo PharmaIndia
- 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
- G04CA52 Dutasteride and Tamsulosin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 4 June 2018
- Identifiers
- RxCUI 996097DailyMed set ID 2ad47033-76f3-447d-8a44-21479e9164c0, 4b89b07e-9d19-47a2-bd53-bc5eef9deed1, d6557691-7910-4006-9268-410583e437d1NDC 59651-063, 70771-1356, 68382-640Application ANDA213300, ANDA207769
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 |
|---|---|---|---|
| 30 capsule in 1 bottle | 68382-640-06 | Zydus LifesciencesIndia | 4 June 2018 |
| 90 capsule in 1 bottle | 68382-640-16 | Zydus LifesciencesIndia | 4 June 2018 |
| 30 capsule in 1 bottle | 70771-1356-3 | Zydus LifesciencesIndia | 4 June 2018 |
| 90 capsule in 1 bottle | 70771-1356-9 | Zydus LifesciencesIndia | 4 June 2018 |
| 30 capsule in 1 bottle | 59651-063-30 | Aurobindo PharmaIndia | 18 July 2024 |
| 90 capsule in 1 bottle | 59651-063-90 | Aurobindo PharmaIndia | 18 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 14 June 2010 | 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 Dutasteride and Tamsulosin 0.5 mg/0.4 mg capsule.
Clinical summary
Dutasteride and Tamsulosin is a fixed-dose combination of a 5-alpha reductase inhibitor and an alpha-adrenergic blocker indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. MedsAcross supplies Dutasteride and Tamsulosin 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 Dutasteride and TamsulosinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Jalyn prescribing information (Waylis Therapeutics) · U.S. National Library of Medicine, DailyMed
Need Dutasteride and Tamsulosin 0.5 mg/0.4 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.