IRBESARTAN

Active substance: irbesartan

TABLET · IRBESARTAN 300 mg/1

United StatesActive

Marketing holder: direct rx

Verified 2026-10-09 · openFDA NDC

Composition

Analogues by country

Products with the same active substance registered in other countries.

Country	Products
EU 13	Aprovel irbesartan EMEA/H/C/000141 Sanofi Winthrop Industrie CoAprovel irbesartan, hydrochlorothiazide EMEA/H/C/000222 Sanofi Winthrop Industrie Ifirmacombi irbesartan, hydrochlorothiazide EMEA/H/C/002302 Krka, d.d., Novo mesto Ifirmasta (previously Irbesartan Krka) irbesartan hydrochloride EMEA/H/C/000962 Krka, d.d., Novo mesto Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop) irbesartan, hydrochlorothiazide EMEA/H/C/000783 sanofi-aventis groupe All products in this country (13)

Country

Products

EU 13

Aprovel
irbesartan
EMEA/H/C/000141
Sanofi Winthrop Industrie
CoAprovel
irbesartan, hydrochlorothiazide
EMEA/H/C/000222
Sanofi Winthrop Industrie
Ifirmacombi
irbesartan, hydrochlorothiazide
EMEA/H/C/002302
Krka, d.d., Novo mesto
Ifirmasta (previously Irbesartan Krka)
irbesartan hydrochloride
EMEA/H/C/000962
Krka, d.d., Novo mesto
Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop)
irbesartan, hydrochlorothiazide
EMEA/H/C/000783
sanofi-aventis groupe

Import and control

United Statesprescription only
Source: openFDA NDC · record 01a1208c-298a-771f-a2d3-3d47faf4fe80,01a1208c-3934-7252-b952-11ccf00c1bf4,01a1208c-5027-7329-9018-16a2d5f60e7b,01a1208c-5b37-771e-8379-96f3664329bb,01a1208c-5b39-7070-a4fd-8511e23c0d9c;count=83 · valid from 2026-10-09 · verified 2026-10-09