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Medicine

Finasteride 5 mg tablet

Finasteride · Oral
Available on requestPrescription onlyUS FDAGeneric name

Finasteride 5 mg tablet is a generic prescription medicine for oral use, made by 25 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 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59°…

Key facts

Active ingredient (INN)
Finasteride
Brand
Sold under the generic name
Strength
5 mg
Dosage form
Tablet
Route
Oral
Packs
100 tablets, 30 tablets, 90 tablets and 127 more
Manufacturers
Ascend LaboratoriesIndiaCamber PharmaceuticalsIndiaDr. Reddy's LaboratoriesIndiaAccord HealthcareIndiaAurobindo PharmaIndiaA-S Medication SolutionsExelan PharmaceuticalsRising Pharma HoldingsAtlantic Biologicals CorpsLegacy Pharmaceutical Packaging25 labelers on the register
Origin register
US FDA, United States
Storage
Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). Protect from light and keep container tightly closed.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
D11AX10 Finasteride
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
28 February 2007
Identifiers
RxCUI 310346DailyMed set ID bafe8674-b7ee-47b2-94c1-842164ca6fa1, 8c3b1f6b-0010-4432-8eda-4af3c3573063, 3272651f-b500-4d5d-9e29-22fcd8e24fcb +37NDC 76420-154, 0615-8562, 0904-6830 +37Application ANDA078341, ANDA076437, ANDA090061 +2

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 25 labelers. The register lists 130 packs for this generic presentation, and we confirm the exact pack on the quote.

PackCodeLabelerMarketed since
100 tablet, film coated in 1 bottle16729-090-01Accord HealthcareIndia24 August 2010
30 tablet, film coated in 1 bottle16729-090-10Accord HealthcareIndia28 May 2010
90 tablet, film coated in 1 bottle16729-090-15Accord HealthcareIndia8 June 2010
500 tablet, film coated in 1 bottle16729-090-16Accord HealthcareIndia15 November 2011
100 tablet, film coated in 1 bottle67877-288-01Ascend LaboratoriesIndia5 January 2017
500 tablet, film coated in 1 bottle67877-288-05Ascend LaboratoriesIndia5 January 2017
1000 tablet, film coated in 1 bottle67877-288-10Ascend LaboratoriesIndia5 January 2017
30 tablet, film coated in 1 bottle67877-288-30Ascend LaboratoriesIndia5 January 2017
1 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack67877-288-33Ascend LaboratoriesIndia30 November 2020
90 tablet, film coated in 1 bottle67877-288-90Ascend LaboratoriesIndia5 January 2017
100 tablet, film coated in 1 bottle65862-149-01Aurobindo PharmaIndia30 October 2007
500 tablet, film coated in 1 bottle65862-149-05Aurobindo PharmaIndia30 October 2007
30 tablet, film coated in 1 bottle65862-149-30Aurobindo PharmaIndia30 October 2007
90 tablet, film coated in 1 bottle65862-149-90Aurobindo PharmaIndia30 October 2007
100 tablet, film coated in 1 bottle31722-525-01Camber PharmaceuticalsIndia13 June 2015
500 tablet, film coated in 1 bottle31722-525-05Camber PharmaceuticalsIndia13 June 2015
1000 tablet, film coated in 1 bottle31722-525-10Camber PharmaceuticalsIndia13 June 2015
12 bottle in 1 case / 30 tablet, film coated in 1 bottle31722-525-30Camber PharmaceuticalsIndia13 June 2015
12 bottle in 1 case / 90 tablet, film coated in 1 bottle31722-525-90Camber PharmaceuticalsIndia13 June 2015
100 tablet in 1 bottle55111-172-01Dr. Reddy's LaboratoriesIndia28 February 2007
500 tablet in 1 bottle55111-172-05Dr. Reddy's LaboratoriesIndia28 February 2007
30 tablet in 1 bottle55111-172-30Dr. Reddy's LaboratoriesIndia28 February 2007
10 blister pack in 1 carton / 10 tablet in 1 blister pack55111-172-78Dr. Reddy's LaboratoriesIndia28 February 2007
90 tablet in 1 bottle55111-172-90Dr. Reddy's LaboratoriesIndia28 February 2007
1 tablet, film coated in 1 pouch17856-0090-1Atlantic Biologicals Corps11 January 2021
500 tablet, film coated in 1 bottle76282-412-05Exelan Pharmaceuticals22 May 2015
1000 tablet, film coated in 1 bottle76282-412-10Exelan Pharmaceuticals22 May 2015
30 tablet, film coated in 1 bottle76282-412-30Exelan Pharmaceuticals22 May 2015
90 tablet, film coated in 1 bottle76282-412-90Exelan Pharmaceuticals22 May 2015
30 tablet, film coated in 1 bottle68645-541-54Legacy Pharmaceutical Packaging13 June 2015
500 tablet, film coated in 1 bottle57237-062-05Rising Pharma Holdings30 October 2007
30 tablet, film coated in 1 bottle57237-062-30Rising Pharma Holdings30 October 2007
90 tablet, film coated in 1 bottle57237-062-90Rising Pharma Holdings30 October 2007
30 tablet, film coated in 1 bottle50090-1936-0A-S Medication Solutions20 July 2015
90 tablet, film coated in 1 bottle50090-1936-1A-S Medication Solutions20 July 2015
30 tablet, film coated in 1 bottle50090-4697-0A-S Medication Solutions7 November 2019
90 tablet, film coated in 1 bottle50090-4697-1A-S Medication Solutions7 November 2019
100 tablet, film coated in 1 bottle50090-4697-2A-S Medication Solutions7 November 2019
30 tablet, film coated in 1 bottle50090-6940-0A-S Medication Solutions15 December 2023
90 tablet, film coated in 1 bottle50090-6940-1A-S Medication Solutions15 December 2023

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 19 June 1992Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
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

Alternatives

Other makers and brands of Finasteride 5 mg tablet.

Compare 1

Other strengths and forms of Finasteride

Clinical summary

Finasteride is a 5-alpha reductase inhibitor. It is available as tablets for oral use. MedsAcross supplies Finasteride 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 Finasteride

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

Data sources

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