United States· US:0378-4275_7de6158d-06ad-4500-a485-dafc151c16ff
Valacyclovir Hydrochloride
A medicinal product containing valacyclovir hydrochloride, registered in United States by Mylan Pharmaceuticals Inc..
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- VALACYCLOVIR HYDROCHLORIDE
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 4
- ndc11037842757790 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4275-77)
- ndc11037842759330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4275-93)
- ndc110378-4275-77
- ndc110378-4275-93
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Valacyclovir hydrochloride in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaVALACICLOVIR +PHARMA+pharma arzneimittel gmbh, Graz
- SwitzerlandValaciclovir Sandoz 500 mg, FilmtablettenSandoz Pharmaceuticals AG
- FinlandFlushnilSandoz A/S
- FranceVALACICLOVIR ALMUS 500 mg, comprimé pelliculé sécableSUN PHARMA FRANCE
- SpainTRIDIAVIR 500 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFGLaboratorios Serra Pamies S.A.
- SwedenValaciclovir Actavis 500 mg Filmdragerad tablettActavis Group PTC ehf.
- IrelandValaciclovir 500 mg film-coated tabletsAccord Healthcare Ireland Ltd.
- NetherlandsVALACICLOVIR 500 mg PCH, filmomhulde tablettenPharmachemie B.V.
Authorised across Europe · EMA
The same active substance is authorised in 27 EEA countries. Names it is sold under:
- Austria · Valaciclovir Actavis, Valaciclovir Allen
- Belgium · Valaciclovir Ab, Valaciclovir Sandoz
- Bulgaria · Валтрекс
- Cyprus · Valtrex
- Czechia · Valaciclovir +pharma, Valacilovir Viatris
- Germany · Valaciclovir 1 A Pharma, Valaciclovir Aurobindo
- Denmark · Valaciclovir "sandoz", Valaciclovir 1a Farma
- Estonia · Valaciclovir Actavis, Valtrex
- Spain · Tridiavir, Valaciclovir Almus
- Finland · Flushnil, Valaciclovir Ratiopharm
- France · Valaciclovir Almus, Valaciclovir Arrow
- United Kingdom (Northern Ireland) · Valaciclovir Accord Healthcare, Valaciclovir Aristo
- Greece · Valomed, Valtrex
- Ireland · Valaciclovir Accord Healthcare Ireland, Valaciclovir Bluefish
- Iceland · Valablis Forte, Valablis Normal
- Italy · Talavir, Valaciclovir Aurobindo
- Lithuania · Valaciclovir Actavis, Valtrex
- Luxembourg · Zelitrex
- Latvia · Valaciclovir Actavis, Valtrex
- Netherlands · Valaciclovir Focus, Valaciclovir Hydrochloride Hydrate Aurobindo
- Norway · Valaciclovir Sandoz, Valaciclovir Viatris
- Poland · Vaciclor
- Portugal · Valaciclovir Arpedex, Valaciclovir Aurobindo
- Romania · Valaciclovir Arena, Valtrex
- Sweden · Valaciclovir Actavis, Valaciclovir Bluefish
- Slovenia · Valtrex
- Slovakia · Valtrex
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/b0326f74-b901-4c6c-b1eb-0cb0316ed146 GET /v1/drugs/b0326f74-b901-4c6c-b1eb-0cb0316ed146?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "ORAL",
"source": "ndc",
"strength": "500",
"substance": "VALACYCLOVIR HYDROCHLORIDE",
"productndc": "0378-4275",
"dosage_form": "TABLET, FILM COATED",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "ANDA078518",
"marketing_category": "ANDA"
}See everything about valacyclovir hydrochloride.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.