Medicine
Valcyte 450 mg tablet
Valcyte 450 mg tablet is a prescription medicine containing Valganciclovir for oral use, marketed by H2-Pharma, 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. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store constituted solution under refrigeration at 2°C to 8°C (36°F to 46°F)…
Key facts
- Active ingredient (INN)
- Valganciclovir
- Brand
- Valcyte
- Strength
- 450 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1 bottle
- Marketing authorisation holder
- H2-Pharma
- Manufacturer
- H2-Pharma
- Origin register
- US FDA, United States
- Storage
- Store constituted solution under refrigeration at 2°C to 8°C (36°F to 46°F) for no longer than 49 days. Do not freeze. Store VALCYTE tablets at 20°C to 25°C (68°F to 77°F), excursions are permitted to 15°C to 30°C (59°F to 86°F). Store dry powder at 20°C to 25°C (68°F to 77°F), excursions are permitted to 15°C to 30°C (59°F to 86°F).
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J05AB14 Valganciclovir
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 29 March 2001
- Identifiers
- RxCUI 284587, 313566, 863559 +1DailyMed set ID 4c517a39-2ded-4c5a-8d56-276853414b31NDC 61269-480Application NDA021304
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle, plastic in 1 carton / 60 tablet, film coated in 1 bottle, plastic | 61269-480-60 | H2-Pharma | 29 March 2001 |
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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 29 March 2001 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US 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 Valganciclovir 450 mg tablet.
Other strengths and forms of Valganciclovir
Clinical summary
Valganciclovir is a cytomegalovirus nucleoside analog DNA polymerase inhibitor indicated for adult Patients, among other approved uses. It is available as powder for oral solution and tablets. MedsAcross supplies Valganciclovir 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 ValganciclovirFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Valcyte prescribing information (H2-Pharma) · U.S. National Library of Medicine, DailyMed
Need Valcyte 450 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.