Medicine
Vardenafil 5 mg tablet
Vardenafil 5 mg tablet is a generic prescription medicine for oral use, made by 6 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
Store at 20° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Vardenafil
- Brand
- Sold under the generic name
- Strength
- 5 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 100 tablets, 90 tablets and 13 more
- Manufacturers
- Zydus LifesciencesIndiaAlembic PharmaceuticalsIndiaMacleods PharmaceuticalsIndiaAvKARELannettTeva Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- G04BE09 Vardenafil
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 November 2018
- Identifiers
- RxCUI 349478, 349479, 349480 +1DailyMed set ID e593ab58-70a4-4095-8091-16a4b6d49e4d, a38de6e1-21ca-4ebe-a3c7-6f849cf8b675, 9b8da728-8f52-4c1f-9f0c-4bd9736e912f +5NDC 0093-7653, 33342-152, 46708-237 +5Application ANDA091347, ANDA204632, ANDA214031 +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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 tablet, film coated in 1 bottle | 46708-237-30 | Alembic PharmaceuticalsIndia | 5 August 2020 |
| 100 tablet, film coated in 1 bottle | 46708-237-31 | Alembic PharmaceuticalsIndia | 5 August 2020 |
| 30 tablet, film coated in 1 bottle | 62332-237-30 | Alembic PharmaceuticalsIndia | 5 August 2020 |
| 100 tablet, film coated in 1 bottle | 62332-237-31 | Alembic PharmaceuticalsIndia | 5 August 2020 |
| 100 tablet, film coated in 1 bottle | 70710-1069-1 | Zydus LifesciencesIndia | 1 November 2018 |
| 30 tablet, film coated in 1 bottle | 70710-1069-3 | Zydus LifesciencesIndia | 1 November 2018 |
| 90 tablet, film coated in 1 bottle | 70710-1069-9 | Zydus LifesciencesIndia | 1 November 2018 |
| 100 tablet, film coated in 1 bottle | 70771-1048-1 | Zydus LifesciencesIndia | 1 November 2018 |
| 30 tablet, film coated in 1 bottle | 70771-1048-3 | Zydus LifesciencesIndia | 1 November 2018 |
| 90 tablet, film coated in 1 bottle | 70771-1048-9 | Zydus LifesciencesIndia | 1 November 2018 |
| 30 tablet in 1 bottle | 33342-152-07 | Macleods PharmaceuticalsIndia | 24 October 2019 |
| 100 tablet in 1 bottle | 33342-152-11 | Macleods PharmaceuticalsIndia | 24 October 2019 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 33342-152-12 | Macleods PharmaceuticalsIndia | 24 October 2019 |
| 30 tablet in 1 bottle | 0527-2801-32 | Lannett | 1 November 2018 |
| 30 tablet, film coated in 1 bottle | 0093-7653-56 | Teva Pharmaceuticals | 3 January 2019 |
| 30 tablet in 1 bottle | 42291-826-30 | AvKARE | 28 July 2025 |
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
Other strengths and forms of Vardenafil
Clinical summary
Vardenafil is a phosphodiesterase 5 inhibitor indicated for the treatment of erectile dysfunction. It is available as tablets and orally disintegrating tablets. MedsAcross supplies Vardenafil 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 VardenafilFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Vardenafil Hydrochloride prescribing information (Lannett) · U.S. National Library of Medicine, DailyMed
- Levitra: European public assessment report (EPAR) · European Medicines Agency
Need Vardenafil 5 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.