United States· US:46708-444_bbfa2906-f126-40a2-a5c4-8cbe19388fcc
Irbesartan and Hydrochlorothiazide
A medicinal product containing irbesartan; hydrochlorothiazide, registered in United States by Alembic Pharmaceuticals 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
- IRBESARTAN; HYDROCHLOROTHIAZIDE
- Manufacturer
- Alembic Pharmaceuticals 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 · 8
- ndc11467084441010 TABLET in 1 BLISTER PACK (46708-444-10)
- ndc11467084443030 TABLET in 1 BOTTLE (46708-444-30)
- ndc11467084449090 TABLET in 1 BOTTLE (46708-444-90)
- ndc1146708444911000 TABLET in 1 BOTTLE (46708-444-91)
- ndc1146708-444-10
- ndc1146708-444-30
- ndc1146708-444-90
- ndc1146708-444-91
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Irbesartan; hydrochlorothiazide in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CanadaIRBESARTAN HCTSIVEM PHARMACEUTICALS ULC
- CzechiaCOAPROVELSanofi Winthrop Industrie, Gentilly
- SpainCOAPROVEL 150 mg/12,5 mg COMPRIMIDOS RECUBIERTOS CON PELICULASanofi Winthrop Industrie
- United KingdomCo-Irbesartan 150mg/12.5mg tabletsWaymade Healthcare Plc
- ItalyCOABESARTS.F. GROUP S.R.L.
- FranceCOAPROVEL 150 mg/12,5 mg, comprimé pelliculéSANOFI WINTHROP INDUSTRIE
- FinlandCoAprovelSanofi Winthrop Industrie
- SwedenCoAprovel 150 mg/12,5 mg Filmdragerad tablettSanofi Winthrop Industrie
Authorised across Europe · EMA
The same active substance is authorised in 23 EEA countries. Names it is sold under:
- Austria · Irbepress-Hct
- Belgium · Irbesartan/Hct Eg, Irbesartan/Hydrochloorthiazide Sandoz
- Bulgaria · Ko-Ирбесан, Ирпрезид
- Cyprus · Converide, Corycardon
- Czechia · Converide
- Germany · Irbecor Comp., Irbepress-Hct
- Denmark · Irbesartan/Hydrochlorthiazid Medical Valley, Irbesartan/Hydrochlorthiazid Stada
- Spain · Converide, Irbesartán /Hidroclorotiazida Sandoz
- France · Irbesartan/Hydrochlorothiazide Arrow, Irbesartan/Hydrochlorothiazide Biogaran
- United Kingdom (Northern Ireland) · Irbesartan And Hydrochlorothiazide, Irbesartan And Hydrochlorothiazide Bristol
- Greece · Converide, Irbegen Plus
- Hungary · Co-Irabel, Irbesartan Hct Sandoz
- Iceland · Coaprovel, Ifirmacombi
- Italy · Coabesart, Irbediur
- Liechtenstein · Coaprovel, Irbesartan Hydrochlorothiazide Zentiva
- Luxembourg · Irbesartan/Hct Eg, Irbesartan/Hydrochlorothiazid Micro Labs
- Malta · Converide, Irbesartan/ Hydrochlorothiazide Aurobindo
- Netherlands · Converide, Irbesartan Comp Hexal
- Norway · Coaprovel, Ifirmacombi
- Portugal · Converide, Irbesartan + Hidroclorotiazida Alter
- Romania · Izgrev
- Sweden · Irbesartan/Hydrochlorothiazide Stada, Irbesartan/Hydroklortiazid Actavis
- Slovakia · Converide
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/2a2035b1-4ce7-4215-a4d5-27bece573cc2 GET /v1/drugs/2a2035b1-4ce7-4215-a4d5-27bece573cc2?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": "300; 25",
"substance": "IRBESARTAN; HYDROCHLOROTHIAZIDE",
"productndc": "46708-444",
"dosage_form": "TABLET",
"dea_schedule": null,
"strength_unit": "mg/1; mg/1",
"application_number": "ANDA091370",
"marketing_category": "ANDA"
}See everything about irbesartan; 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.