United States· US:65862-308_34bf0456-37d0-4d7d-a585-1555b7bc9373
Fosinopril Sodium and Hydrochlorothiazide
A medicinal product containing fosinopril sodium; hydrochlorothiazide, registered in United States by Aurobindo Pharma Limited.
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
- FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE
- Manufacturer
- Aurobindo Pharma Limited
- 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 · 6
- ndc1165862-308-01
- ndc1165862-308-30
- ndc1165862-308-99
- ndc116586230801100 TABLET in 1 BOTTLE (65862-308-01)
- ndc11658623083030 TABLET in 1 BOTTLE (65862-308-30)
- ndc1165862308991000 TABLET in 1 BOTTLE (65862-308-99)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Fosinopril sodium; hydrochlorothiazide in 4 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaMONACE COMBIBausch Health Ireland Limited, Dublin
- FranceFOSINOPRIL HYDROCHLOROTHIAZIDE ARROW 20 mg/12,5 mg, comprimé sécableARROW GENERIQUES
- ItalyFOSICOMBIA.MENARINI INDUSTRIE FARMACEUTICHE RIUNITE S.R.L.
- SpainFOSINOPRIL /HIDROCLOROTIAZIDA TEVA 20 mg/12,5 mg COMPRIMIDOS EFGTeva Pharma S.L.U.
Authorised across Europe · EMA
The same active substance is authorised in 15 EEA countries. Names it is sold under:
- Austria · Fosicomb, Fosinopril-Natrium/Hct Actavis
- Bulgaria · Монозид
- Czechia · Monace Combi
- Estonia · Fosinopril Hct Actavis
- Spain · Fositens Plus
- France · Fosinopril Hydrochlorothiazide Arrow, Fosinopril/Hydrochlorothiazide Arrow Lab
- Hungary · Duopril, Fosicard Plus
- Italy · Fosicombi, Fosinopril E Idroclorotiazide Doc Generici
- Lithuania · Fosinopril Hct Actavis
- Latvia · Fosinopril Hct Actavis
- Malta · Fosinopril + Hydrochlorothiazide Aurobindo
- Netherlands · Fosinoprilnatrium/Hydrochloorthiazide Aurobindo
- Portugal · Fosinopril + Hidroclorotiazida Aurobindo, Fosinopril + Hidroclorotiazida Aurovitas
- Slovenia · Monopril Plus
- Slovakia · Monozide
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/fdf70253-402b-4bc5-ac50-0d213a9eb350 GET /v1/drugs/fdf70253-402b-4bc5-ac50-0d213a9eb350?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": "10; 12.5",
"substance": "FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE",
"productndc": "65862-308",
"dosage_form": "TABLET",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1",
"application_number": "ANDA079245",
"marketing_category": "ANDA"
}See everything about fosinopril sodium; 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.