Medicine
Sildenafil 10 mg/mL powder for oral suspension
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
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.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle, glass in 1 carton / 112 mL in 1 bottle, glass | 70710-1716-4 | Zydus LifesciencesIndia | 27 October 2022 |
| 1 bottle, plastic in 1 carton / 112 mL in 1 bottle, plastic | 70710-1716-5 | Zydus LifesciencesIndia | 27 October 2022 |
| 1 bottle, glass in 1 carton / 112 mL in 1 bottle, glass | 70771-1668-4 | Zydus LifesciencesIndia | 27 October 2022 |
| 1 bottle, plastic in 1 carton / 112 mL in 1 bottle, plastic | 70771-1668-5 | Zydus LifesciencesIndia | 27 October 2022 |
| 1 pouch in 1 carton / 1 bottle in 1 pouch / 112 mL in 1 bottle | 27241-175-29 | Ajanta PharmaIndia | 27 November 2019 |
| 1 bottle, glass in 1 carton / 112 mL in 1 bottle, glass | 67877-648-11 | Ascend LaboratoriesIndia | 29 November 2019 |
| 1 bottle in 1 carton / 112 mL in 1 bottle | 59651-420-11 | Aurobindo PharmaIndia | 23 December 2022 |
| 1 bottle, glass in 1 carton / 112 mL in 1 bottle, glass | 31722-136-31 | Camber PharmaceuticalsIndia | 11 May 2021 |
| 1 bottle in 1 carton / 112 mL in 1 bottle | 68180-283-01 | LupinIndia | 28 September 2022 |
| 1 bottle in 1 carton / 112 mL in 1 bottle | 72205-059-76 | Novadoz PharmaceuticalsIndia | 14 February 2022 |
| 1 bottle, glass in 1 carton / 112 mL in 1 bottle, glass | 60219-2651-1 | Amneal Pharmaceuticals NY | 2 March 2024 |
| 1 bottle, glass in 1 carton / 112 mL in 1 bottle, glass | 69238-1574-1 | Amneal Pharmaceuticals NY | 6 December 2019 |
| 1 bottle in 1 carton / 112 mL in 1 bottle | 0591-4050-94 | Actavis Pharma | 17 August 2020 |
| 1 bottle in 1 carton / 112 mL in 1 bottle | 70954-168-10 | ANI Pharmaceuticals | 31 May 2019 |
| 1 bottle in 1 carton / 112 mL in 1 bottle | 69543-419-72 | Virtus Pharmaceuticals | 2 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.
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.
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 SildenafilFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Sildenafil Citrate prescribing information (Mylan Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Revatio: European public assessment report (EPAR) · European Medicines Agency
- Viagra: European public assessment report (EPAR) · European Medicines Agency
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.