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Medicine

Sildenafil 50 mg tablet

Sildenafil · Oral
Available on requestPrescription onlyUS FDAGeneric name

Sildenafil 50 mg tablet is a generic prescription medicine for oral use, made by 33 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 25°C (77°F), excursions permitted to 15–30°C (59–86°F).

Key facts

Active ingredient (INN)
Sildenafil
Brand
Sold under the generic name
Strength
50 mg
Dosage form
Tablet
Route
Oral
Packs
100 tablets, 500 tablets, 30 tablets and 130 more
Manufacturers
Jubilant Cadista PharmaceuticalsIndiaCamber PharmaceuticalsIndiaTorrent PharmaceuticalsIndiaAurobindo PharmaIndiaMacleods PharmaceuticalsIndiaUmedica LaboratoriesIndiaAjanta PharmaIndiaCadila PharmaceuticalsIndiaCiplaIndiaAdvagen Pharma33 labelers on the register
Origin register
US FDA, United States
Storage
Store at 25°C (77°F), excursions permitted to 15–30°C (59–86°F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
G04BE03 Sildenafil
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
1 December 2017
Identifiers
RxCUI 312950, 314228, 314229DailyMed set ID dc998a9c-0770-111b-e053-2a95a90a88a4, 99bc66a4-05d1-4372-a25a-1153d7af580e, 6d8dbaa6-d61a-46ae-a641-f664104f4714 +37NDC 82647-211, 70518-1844, 70954-408 +37Application ANDA208494, ANDA202659, ANDA216383 +13

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 33 labelers. The register lists 133 packs for this generic presentation, and we confirm the exact pack on the quote.

PackCodeLabelerMarketed since
100 tablet, film coated in 1 bottle31722-710-01Camber PharmaceuticalsIndia11 June 2018
500 tablet, film coated in 1 bottle31722-710-05Camber PharmaceuticalsIndia11 June 2018
30 tablet, film coated in 1 bottle31722-710-30Camber PharmaceuticalsIndia11 June 2018
100 tablet, film coated in 1 bottle31722-966-01Camber PharmaceuticalsIndia1 August 2019
30 tablet, film coated in 1 bottle31722-966-30Camber PharmaceuticalsIndia1 August 2019
30 tablet, film coated in 1 bottle27241-068-03Ajanta PharmaIndia12 October 2018
500 tablet, film coated in 1 bottle27241-068-05Ajanta PharmaIndia29 July 2024
100 tablet, film coated in 1 bottle27241-068-10Ajanta PharmaIndia12 October 2018
100 tablet, film coated in 1 bottle65862-690-01Aurobindo PharmaIndia11 June 2018
500 tablet, film coated in 1 bottle65862-690-05Aurobindo PharmaIndia10 July 2023
30 tablet, film coated in 1 bottle65862-690-30Aurobindo PharmaIndia11 June 2018
1000 tablet, film coated in 1 bottle65862-690-99Aurobindo PharmaIndia11 June 2018
30 tablet, film coated in 1 bottle71209-107-01Cadila PharmaceuticalsIndia1 December 2023
100 tablet, film coated in 1 bottle71209-107-05Cadila PharmaceuticalsIndia1 December 2023
1000 tablet, film coated in 1 bottle71209-107-11Cadila PharmaceuticalsIndia1 December 2023
30 tablet in 1 bottle69097-952-02CiplaIndia10 July 2020
100 tablet in 1 bottle69097-952-07CiplaIndia10 July 2020
100 tablet, film coated in 1 bottle, plastic59746-435-01Jubilant Cadista PharmaceuticalsIndia1 September 2026
100 tablet, film coated in 1 carton59746-435-03Jubilant Cadista PharmaceuticalsIndia1 September 2026
10 tablet, film coated in 1 blister pack59746-435-04Jubilant Cadista PharmaceuticalsIndia1 September 2026
500 tablet, film coated in 1 bottle, plastic59746-435-05Jubilant Cadista PharmaceuticalsIndia1 September 2026
30 tablet, film coated in 1 bottle, plastic59746-435-30Jubilant Cadista PharmaceuticalsIndia1 September 2026
90 tablet, film coated in 1 bottle, plastic59746-435-90Jubilant Cadista PharmaceuticalsIndia1 September 2026
30 tablet, film coated in 1 bottle33342-042-07Macleods PharmaceuticalsIndia19 April 2023
100 tablet, film coated in 1 bottle33342-042-11Macleods PharmaceuticalsIndia19 April 2023
1000 tablet, film coated in 1 bottle33342-042-44Macleods PharmaceuticalsIndia19 April 2023
1 blister pack in 1 carton / 60 tablet, film coated in 1 blister pack33342-042-98Macleods PharmaceuticalsIndia19 April 2023
100 tablet, film coated in 1 bottle13668-187-01Torrent PharmaceuticalsIndia11 June 2018
500 tablet, film coated in 1 bottle13668-187-05Torrent PharmaceuticalsIndia11 June 2018
1000 tablet, film coated in 1 bottle13668-187-10Torrent PharmaceuticalsIndia6 December 2024
1800 tablet, film coated in 1 bottle13668-187-18Torrent PharmaceuticalsIndia11 June 2018
30 tablet, film coated in 1 bottle13668-187-30Torrent PharmaceuticalsIndia11 June 2018
30 tablet, film coated in 1 bottle60290-002-01Umedica LaboratoriesIndia15 February 2026
100 tablet, film coated in 1 bottle60290-002-02Umedica LaboratoriesIndia15 February 2026
1000 tablet, film coated in 1 bottle60290-002-03Umedica LaboratoriesIndia15 February 2026
500 tablet, film coated in 1 bottle60290-002-04Umedica LaboratoriesIndia15 February 2026
1000 tablet, film coated in 1 bottle72888-016-00Advagen Pharma8 November 2021
100 tablet, film coated in 1 bottle72888-016-01Advagen Pharma17 June 2021
30 tablet, film coated in 1 bottle72888-016-30Advagen Pharma17 June 2021
100 tablet, film coated in 1 bottle60219-1752-1Amneal Pharmaceuticals NY28 June 2018

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 27 March 1998Drugs@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

Alternatives

Other makers and brands of Sildenafil 50 mg tablet.

Compare 1

Other strengths and forms of Sildenafil

Clinical summary

Sildenafil is a phosphodiesterase 5 inhibitor indicated for the treatment of erectile dysfunction. It is available as tablets, powder for oral suspension and oral films for intravenous use. MedsAcross supplies Sildenafil 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 Sildenafil

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

Data sources

Need Sildenafil 50 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.