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Medicine

Sildenafil 10 mg/mL powder for oral suspension

Sildenafil · Oral
Available on requestPrescription onlyUS FDAGeneric name

Sildenafil 10 mg/mL powder for oral suspension is a generic prescription medicine for oral use, made by 11 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

Do not freeze. Store below 30°C (86°F) in the original package in order to…

Key facts

Active ingredient (INN)
Sildenafil
Brand
Sold under the generic name
Strength
10 mg/mL
Dosage form
Powder for oral suspension
Route
Oral
Packs
1 bottle, 1 pouch and 12 more
Manufacturers
Zydus LifesciencesIndiaAjanta PharmaIndiaAscend LaboratoriesIndiaAurobindo PharmaIndiaCamber PharmaceuticalsIndiaLupinIndiaNovadoz PharmaceuticalsIndiaAmneal Pharmaceuticals NYActavis PharmaANI Pharmaceuticals
Origin register
US FDA, United States
Storage
Do not freeze. Store below 30°C (86°F) in the original package in order to protect from moisture. Recommended storage for reconstituted oral suspension: Store below 30°C (86°F) or in refrigerator at 2°C to 8°C (36°F to 46°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
31 May 2019
Identifiers
RxCUI 1307427DailyMed set ID 0e6428c0-e0e9-4fc0-8615-6a9678d2286c, 8526e8f2-4bb4-430b-9e38-68ee68caa5a4, a0fa4162-e1b7-4293-ab7d-c5b375779060 +10NDC 0591-4050, 69543-419, 67877-648 +10Application ANDA211534, ANDA213814, ANDA212440 +8

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
1 bottle, glass in 1 carton / 112 mL in 1 bottle, glass70710-1716-4Zydus LifesciencesIndia27 October 2022
1 bottle, plastic in 1 carton / 112 mL in 1 bottle, plastic70710-1716-5Zydus LifesciencesIndia27 October 2022
1 bottle, glass in 1 carton / 112 mL in 1 bottle, glass70771-1668-4Zydus LifesciencesIndia27 October 2022
1 bottle, plastic in 1 carton / 112 mL in 1 bottle, plastic70771-1668-5Zydus LifesciencesIndia27 October 2022
1 pouch in 1 carton / 1 bottle in 1 pouch / 112 mL in 1 bottle27241-175-29Ajanta PharmaIndia27 November 2019
1 bottle, glass in 1 carton / 112 mL in 1 bottle, glass67877-648-11Ascend LaboratoriesIndia29 November 2019
1 bottle in 1 carton / 112 mL in 1 bottle59651-420-11Aurobindo PharmaIndia23 December 2022
1 bottle, glass in 1 carton / 112 mL in 1 bottle, glass31722-136-31Camber PharmaceuticalsIndia11 May 2021
1 bottle in 1 carton / 112 mL in 1 bottle68180-283-01LupinIndia28 September 2022
1 bottle in 1 carton / 112 mL in 1 bottle72205-059-76Novadoz PharmaceuticalsIndia14 February 2022
1 bottle, glass in 1 carton / 112 mL in 1 bottle, glass60219-2651-1Amneal Pharmaceuticals NY2 March 2024
1 bottle, glass in 1 carton / 112 mL in 1 bottle, glass69238-1574-1Amneal Pharmaceuticals NY6 December 2019
1 bottle in 1 carton / 112 mL in 1 bottle0591-4050-94Actavis Pharma17 August 2020
1 bottle in 1 carton / 112 mL in 1 bottle70954-168-10ANI Pharmaceuticals31 May 2019
1 bottle in 1 carton / 112 mL in 1 bottle69543-419-72Virtus Pharmaceuticals2 August 2021

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 10 mg/mL powder for oral suspension.

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 10 mg/mL powder for oral suspension 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.