Medicine
Valacyclovir 500 mg tablet
Valacyclovir 500 mg tablet is a generic prescription medicine for oral use, made by 33 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 o to 25 • C (68 o to 77 • F).
Key facts
- Active ingredient (INN)
- Valacyclovir
- Brand
- Sold under the generic name
- Strength
- 500 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 10 blister pack and 187 more
- Manufacturers
- Camber PharmaceuticalsIndiaAurobindo PharmaIndiaJubilant Cadista PharmaceuticalsIndiaSun Pharmaceutical IndustriesIndiaTime Cap LaboratoriesIndiaRising Pharma HoldingsYiling PharmaceuticalChartwell RXMylan PharmaceuticalsNuCare Pharmaceuticals,Inc33 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20 o to 25 • C (68 o to 77 • F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J05AB11 Valacyclovir
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 31 January 2007
- Identifiers
- RxCUI 313565, 313564DailyMed set ID 7681a6f4-a6e7-4277-adbd-38837d5ead6b, 4acf51de-26f7-42b2-8acc-61b800627ef3, 8d1645c0-fd03-4992-9372-98026a26b3af +37NDC 85766-054, 16714-698, 57237-042 +37Application ANDA090682, ANDA201506, ANDA078518 +4
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
A sample of 40 packs from 33 labelers. The register lists 190 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, film coated in 1 bottle | 65862-448-01 | Aurobindo PharmaIndia | 24 May 2010 |
| 500 tablet, film coated in 1 bottle | 65862-448-05 | Aurobindo PharmaIndia | 24 May 2010 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 65862-448-10 | Aurobindo PharmaIndia | 24 May 2010 |
| 30 tablet, film coated in 1 bottle | 65862-448-30 | Aurobindo PharmaIndia | 24 May 2010 |
| 3500 tablet, film coated in 1 bottle | 65862-448-35 | Aurobindo PharmaIndia | 24 May 2010 |
| 90 tablet, film coated in 1 bottle | 65862-448-90 | Aurobindo PharmaIndia | 24 May 2010 |
| 100 tablet, film coated in 1 bottle | 31722-704-01 | Camber PharmaceuticalsIndia | 25 May 2015 |
| 500 tablet, film coated in 1 bottle | 31722-704-05 | Camber PharmaceuticalsIndia | 25 May 2015 |
| 30 tablet, film coated in 1 bottle | 31722-704-30 | Camber PharmaceuticalsIndia | 25 May 2015 |
| 10 tablet, film coated in 1 blister pack | 31722-704-31 | Camber PharmaceuticalsIndia | 25 May 2015 |
| 10 tablet, film coated in 1 blister pack | 31722-704-32 | Camber PharmaceuticalsIndia | 25 May 2015 |
| 60 tablet, film coated in 1 bottle | 31722-704-60 | Camber PharmaceuticalsIndia | 25 May 2015 |
| 90 tablet, film coated in 1 bottle | 31722-704-90 | Camber PharmaceuticalsIndia | 25 May 2015 |
| 100 tablet, film coated in 1 bottle | 59746-324-01 | Jubilant Cadista PharmaceuticalsIndia | 5 April 2012 |
| 10 tablet, film coated in 1 bottle | 59746-324-10 | Jubilant Cadista PharmaceuticalsIndia | 5 April 2012 |
| 30 tablet, film coated in 1 bottle | 59746-324-30 | Jubilant Cadista PharmaceuticalsIndia | 5 April 2012 |
| 250 tablet, film coated in 1 bottle | 59746-324-37 | Jubilant Cadista PharmaceuticalsIndia | 5 April 2012 |
| 300 tablet, film coated in 1 bottle | 59746-324-47 | Jubilant Cadista PharmaceuticalsIndia | 5 April 2012 |
| 90 tablet, film coated in 1 bottle | 59746-324-90 | Jubilant Cadista PharmaceuticalsIndia | 5 April 2012 |
| 10 tablet, film coated in 1 bottle | 63304-904-03 | Sun Pharmaceutical IndustriesIndia | 19 December 2020 |
| 500 tablet, film coated in 1 bottle | 63304-904-05 | Sun Pharmaceutical IndustriesIndia | 19 December 2020 |
| 100 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack | 63304-904-77 | Sun Pharmaceutical IndustriesIndia | 19 December 2020 |
| 90 tablet, film coated in 1 bottle | 63304-904-90 | Sun Pharmaceutical IndustriesIndia | 19 December 2020 |
| 30 tablet in 1 bottle | 49483-690-03 | Time Cap LaboratoriesIndia | 14 July 2021 |
| 10 tablet in 1 blister pack | 49483-690-04 | Time Cap LaboratoriesIndia | 14 July 2021 |
| 42 tablet in 1 bottle | 49483-690-41 | Time Cap LaboratoriesIndia | 14 July 2021 |
| 500 tablet in 1 bottle | 49483-690-50 | Time Cap LaboratoriesIndia | 14 July 2021 |
| 30 tablet in 1 bottle | 62135-613-30 | Chartwell RX | 21 June 2023 |
| 90 tablet in 1 bottle | 62135-613-90 | Chartwell RX | 21 June 2023 |
| 30 blister pack in 1 carton / 1 tablet, film coated in 1 blister pack | 51079-093-03 | Mylan Institutional | 7 March 2011 |
| 90 tablet, film coated in 1 bottle, plastic | 0378-4275-77 | Mylan Pharmaceuticals | 24 May 2010 |
| 30 tablet, film coated in 1 bottle, plastic | 0378-4275-93 | Mylan Pharmaceuticals | 24 May 2010 |
| 500 tablet, film coated in 1 bottle | 57237-042-05 | Rising Pharma Holdings | 24 May 2010 |
| 30 tablet, film coated in 1 bottle | 57237-042-30 | Rising Pharma Holdings | 24 May 2010 |
| 90 tablet, film coated in 1 bottle | 57237-042-90 | Rising Pharma Holdings | 24 May 2010 |
| 30 tablet in 1 bottle | 69117-0010-1 | Yiling Pharmaceutical | 1 October 2018 |
| 90 tablet in 1 bottle | 69117-0010-2 | Yiling Pharmaceutical | 1 October 2018 |
| 500 tablet in 1 bottle | 69117-0010-3 | Yiling Pharmaceutical | 1 October 2018 |
| 10 tablet, film coated in 1 bottle | 68071-2738-1 | NuCare Pharmaceuticals,Inc | 27 May 2022 |
| 14 tablet, film coated in 1 bottle | 68071-2738-4 | NuCare Pharmaceuticals,Inc | 27 May 2022 |
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 23 June 1995 | 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 Valacyclovir 500 mg tablet.
Other strengths and forms of Valacyclovir
Clinical summary
Valacyclovir is a herpes simplex virus nucleoside analog DNA polymerase inhibitor indicated for adult Patients, among other approved uses. It is available as tablets for oral use. MedsAcross supplies Valacyclovir 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 ValacyclovirFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- VALTREX prescribing information (GlaxoSmithKline) · U.S. National Library of Medicine, DailyMed
Need Valacyclovir 500 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.