United States· US:33342-058_f2ef667a-4871-4f28-a0b3-3f79fbbe180c

Irbesartan and Hydrochlorothiazide

A medicinal product containing irbesartan; hydrochlorothiazide, registered in United States by Macleods Pharmaceuticals Limited.

US label

Checked against FDA National Drug Code directory (United States) on September 27, 2026

Informational only — not a medical device.

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The record

At a glance

FDA National Drug Code directory (United States)

Active substance: IRBESARTAN; HYDROCHLOROTHIAZIDE
Manufacturer: Macleods 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 · 10

ndc11
3334205806
3 BLISTER PACK in 1 CARTON (33342-058-06) / 10 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
3334205807
30 TABLET, FILM COATED in 1 BOTTLE (33342-058-07)
ndc11
3334205810
90 TABLET, FILM COATED in 1 BOTTLE (33342-058-10)
ndc11
3334205815
500 TABLET, FILM COATED in 1 BOTTLE (33342-058-15)
ndc11
3334205839
9 BLISTER PACK in 1 CARTON (33342-058-39) / 10 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
33342-058-06
ndc11
33342-058-07
ndc11
33342-058-10
ndc11
33342-058-15
ndc11
33342-058-39

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.

All irbesartan; hydrochlorothiazide products

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/ef6d0fbb-249c-4aca-82ac-2b8f62528693
GET /v1/drugs/ef6d0fbb-249c-4aca-82ac-2b8f62528693?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; 12.5",
  "substance": "IRBESARTAN; HYDROCHLOROTHIAZIDE",
  "productndc": "33342-058",
  "dosage_form": "TABLET, FILM COATED",
  "dea_schedule": null,
  "strength_unit": "mg/1; mg/1",
  "application_number": "ANDA202414",
  "marketing_category": "ANDA"
}

API reference MCP server Plans

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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.

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