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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.

US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedIrbesartan and HydrochlorothiazideATC—REGISTER NO.US:46708-444_bbfa2906…PACKS LISTED8CHECKEDSeptember 27, 2026

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

  • ndc11
    4670844410
    10 TABLET in 1 BLISTER PACK (46708-444-10)
  • ndc11
    4670844430
    30 TABLET in 1 BOTTLE (46708-444-30)
  • ndc11
    4670844490
    90 TABLET in 1 BOTTLE (46708-444-90)
  • ndc11
    4670844491
    1000 TABLET in 1 BOTTLE (46708-444-91)
  • ndc11
    46708-444-10
  • ndc11
    46708-444-30
  • ndc11
    46708-444-90
  • ndc11
    46708-444-91

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.

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/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.