Medicine
Valganciclovir 450 mg tablet
Valganciclovir 450 mg tablet is a generic prescription medicine for oral use, made by 10 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°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Valganciclovir
- Brand
- Sold under the generic name
- Strength
- 450 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 60 tablets, 500 tablets and 20 more
- Manufacturers
- Aurobindo PharmaIndiaDr. Reddy's LaboratoriesIndiaCamber PharmaceuticalsIndiaStrides PharmaIndiaAjanta PharmaIndiaAmerican Health PackagingMajor PharmaceuticalsAvKAREAvPAKNorthStar Rx
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- 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
- 15 December 2014
- Identifiers
- RxCUI 313566DailyMed set ID d13cc8ad-eaf0-4ae6-89da-a850a08b1067, 85177859-e0f5-6d83-17f3-29cae1db96c3, 89a934f0-85a3-44c1-82e5-d09d1738e08d +9NDC 27241-158, 50268-787, 64380-161 +9Application ANDA212234, ANDA205166, ANDA200790 +3
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 in 1 bottle | 43598-356-30 | Dr. Reddy's LaboratoriesIndia | 12 December 2017 |
| 60 tablet in 1 bottle | 43598-356-60 | Dr. Reddy's LaboratoriesIndia | 12 December 2017 |
| 500 tablet, film coated in 1 bottle | 55111-762-05 | Dr. Reddy's LaboratoriesIndia | 15 December 2014 |
| 60 tablet, film coated in 1 bottle | 55111-762-60 | Dr. Reddy's LaboratoriesIndia | 15 December 2014 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 55111-762-78 | Dr. Reddy's LaboratoriesIndia | 15 December 2014 |
| 60 tablet, film coated in 1 bottle, plastic | 64380-153-01 | Strides PharmaIndia | 12 September 2022 |
| 60 tablet, film coated in 1 bottle, plastic | 64380-161-01 | Strides PharmaIndia | 16 June 2025 |
| 60 tablet in 1 bottle | 27241-158-60 | Ajanta PharmaIndia | 26 December 2019 |
| 100 tablet in 1 bottle | 65862-753-01 | Aurobindo PharmaIndia | 31 March 2016 |
| 500 tablet in 1 bottle | 65862-753-05 | Aurobindo PharmaIndia | 31 March 2016 |
| 180 tablet in 1 bottle | 65862-753-18 | Aurobindo PharmaIndia | 31 March 2016 |
| 60 tablet in 1 bottle | 65862-753-60 | Aurobindo PharmaIndia | 31 March 2016 |
| 1000 tablet in 1 bottle | 65862-753-99 | Aurobindo PharmaIndia | 31 March 2016 |
| 10 tablet, film coated in 1 blister pack | 31722-832-31 | Camber PharmaceuticalsIndia | 18 March 2016 |
| 10 tablet, film coated in 1 carton | 31722-832-32 | Camber PharmaceuticalsIndia | 18 March 2016 |
| 60 tablet, film coated in 1 bottle | 31722-832-60 | Camber PharmaceuticalsIndia | 18 March 2016 |
| 20 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack | 68084-965-19 | American Health Packaging | 6 November 2024 |
| 30 blister pack in 1 box, unit-dose / 1 tablet, film coated in 1 blister pack | 68084-965-25 | American Health Packaging | 16 January 2015 |
| 60 tablet, film coated in 1 bottle | 42291-973-60 | AvKARE | 21 December 2023 |
| 20 blister pack in 1 box, unit-dose / 1 tablet, film coated in 1 blister pack | 50268-787-12 | AvPAK | 27 July 2016 |
| 30 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack | 0904-6796-04 | Major Pharmaceuticals | 18 March 2016 |
| 20 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack | 0904-6796-10 | Major Pharmaceuticals | 18 March 2016 |
| 60 tablet in 1 bottle | 72603-750-01 | NorthStar Rx | 1 March 2026 |
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 Valganciclovir 450 mg tablet for your hospital or patient?
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