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Medicine

Silodosin 8 mg capsule

Silodosin · Oral
Available on requestPrescription onlyUS FDAGeneric name

Silodosin 8 mg capsule is a generic prescription medicine for oral use, made by 12 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

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Store at 20° to 25ºC (68° to 77ºF), excursions permitted between 15º to 30ºC…

Key facts

Active ingredient (INN)
Silodosin
Brand
Sold under the generic name
Strength
8 mg
Dosage form
Capsule
Route
Oral
Packs
30 capsules, 90 capsules, 1000 capsules and 31 more
Manufacturers
Alembic PharmaceuticalsIndiaCamber PharmaceuticalsIndiaMacleods PharmaceuticalsIndiaAjanta PharmaIndiaAurobindo PharmaIndiaLupinIndiaNovadoz PharmaceuticalsIndiaAmneal Pharmaceuticals NYBryant Ranch PrepackCreekwood Pharmaceuticals
Origin register
US FDA, United States
Storage
Store at 20° to 25ºC (68° to 77ºF), excursions permitted between 15º to 30ºC (59° to 86ºF). Protect from light and moisture.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
G04CA04 Silodosin
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
3 December 2018
Identifiers
RxCUI 809477, 826612DailyMed set ID ea3bbafb-d32a-d0d3-e053-2a95a90ac387, 455c98be-aa01-4393-915f-34d1859005c0, b9880aad-5fbe-470b-a7a0-d963ba4bc98b +12NDC 42291-778, 60219-1420, 31722-636 +12Application ANDA209745, ANDA204793, ANDA213230 +6

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.

PackCodeLabelerMarketed since
30 capsule in 1 bottle46708-406-30Alembic PharmaceuticalsIndia25 November 2019
90 capsule in 1 bottle46708-406-90Alembic PharmaceuticalsIndia25 November 2019
1000 capsule in 1 bottle46708-406-91Alembic PharmaceuticalsIndia25 November 2019
30 capsule in 1 bottle62332-406-30Alembic PharmaceuticalsIndia25 November 2019
90 capsule in 1 bottle62332-406-90Alembic PharmaceuticalsIndia25 November 2019
1000 capsule in 1 bottle62332-406-91Alembic PharmaceuticalsIndia25 November 2019
30 capsule in 1 bottle27241-145-01Ajanta PharmaIndia3 December 2018
90 capsule in 1 bottle27241-145-03Ajanta PharmaIndia3 December 2018
30 capsule in 1 bottle59651-096-30Aurobindo PharmaIndia10 December 2018
90 capsule in 1 bottle59651-096-90Aurobindo PharmaIndia10 December 2018
30 capsule in 1 bottle31722-636-30Camber PharmaceuticalsIndia14 February 2020
30 capsule in 1 bottle31722-636-31Camber PharmaceuticalsIndia14 February 2020
90 capsule in 1 bottle31722-636-90Camber PharmaceuticalsIndia14 February 2020
90 capsule in 1 bottle31722-636-91Camber PharmaceuticalsIndia14 February 2020
30 capsule in 1 bottle68180-741-06LupinIndia3 December 2018
90 capsule in 1 bottle68180-741-09LupinIndia3 December 2018
30 capsule in 1 bottle33342-385-07Macleods PharmaceuticalsIndia3 December 2018
90 capsule in 1 bottle33342-385-10Macleods PharmaceuticalsIndia3 December 2018
100 blister pack in 1 carton / 10 capsule in 1 blister pack33342-385-12Macleods PharmaceuticalsIndia3 December 2018
30 capsule in 1 bottle72205-010-30Novadoz PharmaceuticalsIndia3 December 2018
90 capsule in 1 bottle72205-010-90Novadoz PharmaceuticalsIndia3 December 2018
30 capsule in 1 bottle60219-1420-3Amneal Pharmaceuticals NY3 December 2018
90 capsule in 1 bottle60219-1420-9Amneal Pharmaceuticals NY3 December 2018
30 capsule in 1 bottle69238-1420-3Amneal Pharmaceuticals NY3 December 2018
90 capsule in 1 bottle69238-1420-9Amneal Pharmaceuticals NY3 December 2018
30 capsule in 1 bottle82619-114-01Creekwood Pharmaceuticals14 November 2024
90 capsule in 1 bottle82619-114-02Creekwood Pharmaceuticals14 November 2024
30 capsule in 1 bottle71335-3128-1Bryant Ranch Prepack29 April 2026
90 capsule in 1 bottle71335-3128-2Bryant Ranch Prepack29 April 2026
30 capsule in 1 bottle72162-2447-3Bryant Ranch Prepack14 November 2024
90 capsule in 1 bottle72162-2447-9Bryant Ranch Prepack14 November 2024
90 capsule in 1 bottle42291-778-90AvKARE4 October 2022
30 capsule in 1 bottle, plastic72789-090-30PD-Rx Pharmaceuticals23 June 2020
90 capsule in 1 bottle, plastic72789-090-90PD-Rx Pharmaceuticals23 June 2020

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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 8 October 2008Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS 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

Other strengths and forms of Silodosin

Clinical summary

Silodosin is an alpha-adrenergic blocker indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH), among other approved uses. It is available as capsules for oral use. MedsAcross supplies Silodosin 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 Silodosin

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Silodosin 8 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.