United States· US:53746-848_1ed15f09-2051-401f-a320-5f04b85ac8e2
Valsartan and Hydrochlorothiazide
A medicinal product containing valsartan; hydrochlorothiazide, registered in United States by Amneal Pharmaceuticals of New York LLC.
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
- VALSARTAN; HYDROCHLOROTHIAZIDE
- Manufacturer
- Amneal Pharmaceuticals of New York LLC
- 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 · 2
- ndc11537468489090 TABLET, FILM COATED in 1 BOTTLE (53746-848-90)
- ndc1153746-848-90
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Valsartan; hydrochlorothiazide in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaJANARTANKrka, d.d., Novo mesto, Novo mesto
- PolandAuroValsart HCTAurovitas Pharma Polska Sp. z o.o.
- SpainCO-DIOVAN 160 mg/12,5 mg COMPRIMIDOS RECUBIERTOS CON PELICULAMelyfarma S.L.
- ItalyCOMBISARTANA.MENARINI INDUSTRIE FARMACEUTICHE RIUNITE S.R.L.
- United KingdomCo-Diovan 160mg/12.5mg tabletsDE Pharmaceuticals
- FinlandDiovan CompNovartis Finland Oy
- SwedenDiovan Comp 160 mg/12,5 mg Filmdragerad tablettNovartis Sverige AB
- FranceCOTAREG 160 mg/12,5 mg, comprimé pelliculéNOVARTIS PHARMA
Authorised across Europe · EMA
The same active substance is authorised in 30 EEA countries. Names it is sold under:
- Austria · Co-Diovan, Co-Diovan Forte
- Belgium · Co-Diovane, Co-Valsartan
- Bulgaria · Suvartar H, Валсавил Комп Stada Arzneimittel
- Cyprus · Co-Diovan, Cotroval
- Czechia · Blessin Plus H, Janartan
- Germany · Codiovan, Codiovan Forte
- Denmark · Tevavaltan Comp, Tevavaltan Comp.
- Estonia · Valsacombi, Valsartan/Hydrochlorothiazide Krka
- Spain · Co-Diován, Co-Diován Forte
- Finland · Diovan Comp, Valsartan/Hydrochlorothiazide Krka
- France · Cotareg, Valsartan / Hydrochlorothiazide Viatris
- United Kingdom (Northern Ireland) · Co-Diovan, Valsartan And Hydrochlorothiazide
- Greece · Co-Diovan, Co-Valsareta
- Croatia · Co-Diovan, Val Plus
- Hungary · Co-Valsacor, Diovan Hct
- Ireland · Co-Diovan, Co-Vatan
- Iceland · Almertan, Malartan Hct
- Italy · Combisartan, Corixil
- Lithuania · Suvartar Hct, Valsacombi
- Luxembourg · Co-Diovane, Co-Valsartan Eg
- Latvia · Valsacombi
- Malta · Co-Diovan, Valsartan And Hydrochlorothiazide Aurobindo Pharma
- Netherlands · Co-Diovan, Exsartazide
- Norway · Diovan Comp, Valsartan/Hydrochlorothiazide Krka
- Poland · Aurovalsart Hct, Co-Bespres
- Portugal · Co-Diovan, Co-Diovan Forte
- Romania · Co-Valsacor
- Sweden · Diovan Comp, Valsarstad Comp
- Slovenia · Co-Diovan, Valsacombi
- Slovakia · Co-Valsacor, Valsartan Hct Teva
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/e7d6ca97-87cb-462e-b687-fe1bfdb89ecc GET /v1/drugs/e7d6ca97-87cb-462e-b687-fe1bfdb89ecc?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": "320; 12.5",
"substance": "VALSARTAN; HYDROCHLOROTHIAZIDE",
"productndc": "53746-848",
"dosage_form": "TABLET, FILM COATED",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1",
"application_number": "ANDA204382",
"marketing_category": "ANDA"
}See everything about valsartan; hydrochlorothiazide.
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.