United States· US:33342-047_6838a6ad-aea4-4f3b-a3f8-466c76b41e75

Irbesartan

A irbesartan product containing irbesartan, registered in United States by Macleods Pharmaceuticals Limited. The same ATC class is registered in 18 of our 19 countries.

ATC C09CA04US 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…normalisedIrbesartanATCC09CA04REGISTER NO.US:33342-047_6838a6ad…PACKS LISTED10CHECKEDJuly 26, 2026

Where it is registered

Irbesartan is registered in 18 of 19 countries.

Countries holding a registration under ATC C09CA04 (irbesartan), each read from that country’s own register.

  • This record: United States, from FDA National Drug Code directory (United States)
  • 11 of them publish a price we can compare per daily dose

Irbesartan · ATC C09CA04

18 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Germany
  • Icelandprice
  • Ireland
  • Italyprice
  • Netherlands
  • Norwayprice
  • Polandprice
  • Spainprice
  • Sweden
  • Switzerlandprice
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

Price per daily dose

What a daily dose of irbesartan costs, country by country.

Normalised to the WHO defined daily dose (0.15 g), the median price runs from $0.14 in France to $0.68 in Switzerland — a ×4.7 gap.

  • United States: $0.16 per daily dose (median across products in the class)
  • Public list prices, converted to USD at the rate date shown
  • US figures are pharmacy acquisition cost (CMS NADAC), not retail

Irbesartan · price per daily dose (0.15 g)

USD · FX 28 Sept 2026

  • CH Switzerland$0.68
  • ES Spain$0.31
  • IT Italy$0.26
  • US United States$0.16 (acquisition cost)
  • FR France$0.14
Median listed price per WHO defined daily dose, in each market that publishes a price. US = pharmacy acquisition cost (CMS NADAC), not a retail price. Open the full comparison

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
IRBESARTAN
Manufacturer
Macleods Pharmaceuticals Limited
Country
United States (US)
ATC code
C09CA04
ATC class
Irbesartan
Defined daily dose
0.15 g, O
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
July 26, 2026

Packs & prices · 10

  • ndc11
    33342-047-68
  • ndc11
    3334204707
    30 TABLET in 1 BOTTLE (33342-047-07)
  • ndc11
    3334204710
    90 TABLET in 1 BOTTLE (33342-047-10)
  • ndc11
    3334204712
    10 BLISTER PACK in 1 CARTON (33342-047-12) / 10 TABLET in 1 BLISTER PACK
  • ndc11
    3334204715
    500 TABLET in 1 BOTTLE (33342-047-15)
  • ndc11
    3334204768
    13600 TABLET in 1 POUCH (33342-047-68)
  • ndc11
    33342-047-07
  • ndc11
    33342-047-10
  • ndc11
    33342-047-12
  • ndc11
    33342-047-15

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Interactions

371 interactions on record for irbesartan.

Graded by severity as the source publishes them — 7 severe. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan

Irbesartan · interactions on record

371 records

  • 7 severe
  • 128 moderate
  • 3 minor
  • 152 info

Most severe, free to view

  • Potassium chlorideA12BA01severe
  • Potassium citrateA12BA02severe
  • Potassium gluconateA12BA05severe
  • Potassium chlorideB05XA01severe

81 more interactions with mechanism and management, from a commercially licensed source.

Sign in to check
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Irbesartan in 17 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All irbesartan products

Authorised across Europe · EMA

The same active substance is authorised in 24 EEA countries. Names it is sold under:

  • Austria · Irbepress, Irbesartan Hexal
  • Belgium · Irbesartan Eg, Irbesartan Sandoz
  • Bulgaria · Ирбесан, Ирбесо
  • Cyprus · Converium, Irbesartan Vocate
  • Czechia · Isame
  • Germany · Irbepress, Irbesartan 1 A Pharma
  • Denmark · Irbesartan Accord, Irbesartan Jubilant
  • Spain · Irbesartán Almus, Irbesartán Alter
  • France · Irbesartan Accord, Irbesartan Arrow
  • United Kingdom (Northern Ireland) · Irbesartan, Irbesartan Accord
  • Greece · Besartan, Irbegen
  • Hungary · Irabel, Irbesartan Sandoz
  • Ireland · Irbesartan Clonmel, Irbesartan Rowa
  • Iceland · Aprovel, Ifirmasta
  • Italy · Abesart, Irbesartan Accord
  • Liechtenstein · Aprovel, Irbesartan Teva
  • Luxembourg · Irbesartan Eg, Irbesartan Viatris
  • Malta · Irbesartan Aurobindo Pharma (Malta)
  • Netherlands · Artibesan, Irbesartan Accord
  • Norway · Aprovel, Ifirmasta
  • Poland · Irbesartan Aurovitas
  • Portugal · Irbesartan Alter, Irbesartan Aurovitas
  • Romania · Irbesartan Terapia
  • Sweden · Irbesartan Accord, Irbesartan Actavis

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/3c005357-16e4-49f6-9b79-ad7eea975962
GET /v1/drugs/3c005357-16e4-49f6-9b79-ad7eea975962?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": "75",
  "substance": "IRBESARTAN",
  "productndc": "33342-047",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA202254",
  "marketing_category": "ANDA"
}

See everything about irbesartan.

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.