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Medicines · US (FDA)
ACE inhibitors and sartans

FDA 2012

Renin-inhibitors

Irbesartan and Hydrochlorothiazide

Approved 22 Oct 2012OralTablet

The FDA lists this product in 37 strengths and forms.

Official labelAsk Osler about it

On this page

Composition
Strengths and forms
Official product information

The table holds no label text for this product yet, only the facts beside it. The official product information has the full text.

Composition

Active ingredients: HYDROCHLOROTHIAZIDE 12.5MG; IRBESARTAN 300MG

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

HYDROCHLOROTHIAZIDE 25MG; IRBESARTAN 300MG · TabletANDA077369-003 · Discontinued
HYDROCHLOROTHIAZIDE 12.5MG; IRBESARTAN 150MG · TabletANDA077369-001 · Prescription
HYDROCHLOROTHIAZIDE 12.5MG; IRBESARTAN 300MG · TabletANDA077369-002 · Prescription
HYDROCHLOROTHIAZIDE 12.5MG; IRBESARTAN 300MG · TabletANDA090351-002 · Prescription
HYDROCHLOROTHIAZIDE 25MG; IRBESARTAN 300MG · TabletANDA090351-003 · Prescription
HYDROCHLOROTHIAZIDE 12.5MG; IRBESARTAN 150MG · TabletANDA090351-001 · Prescription
HYDROCHLOROTHIAZIDE 12.5MG; IRBESARTAN 150MG · TabletANDA091539-001 · Discontinued
HYDROCHLOROTHIAZIDE 12.5MG; IRBESARTAN 300MG · TabletThis page
HYDROCHLOROTHIAZIDE 12.5MG; IRBESARTAN 300MG · Tablet

More in ACE inhibitors and sartans

Widaplikamlodipine besylate · Tablet
Sacubitril and Valsartansacubitril · Tablet

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

ANDA201524-002 · Discontinued

HYDROCHLOROTHIAZIDE 12.5MG; IRBESARTAN 150MG · TabletANDA201524-001 · Discontinued

HYDROCHLOROTHIAZIDE 25MG/300MG; IRBESARTAN · TabletANDA203072-003 · Tentative approval

HYDROCHLOROTHIAZIDE 12.5MG; IRBESARTAN 150MG · TabletANDA203072-001 · Prescription

HYDROCHLOROTHIAZIDE 12.5MG; IRBESARTAN 300MG · TabletANDA203072-002 · Prescription

HYDROCHLOROTHIAZIDE 25MG; IRBESARTAN 300MG · TabletANDA077969-003 · Discontinued

HYDROCHLOROTHIAZIDE 12.5MG; IRBESARTAN 150MG · TabletANDA077969-001 · Discontinued

HYDROCHLOROTHIAZIDE 12.5MG; IRBESARTAN 300MG · TabletANDA077969-002 · Discontinued

HYDROCHLOROTHIAZIDE 12.5MG; IRBESARTAN 300MG · TabletANDA201505-002 · Discontinued

HYDROCHLOROTHIAZIDE 12.5MG; IRBESARTAN 150MG · TabletANDA201505-001 · Discontinued

HYDROCHLOROTHIAZIDE 12.5MG; IRBESARTAN 300MG · TabletANDA203500-002 · Prescription

HYDROCHLOROTHIAZIDE 12.5MG; IRBESARTAN 150MG · TabletANDA203500-001 · Prescription

HYDROCHLOROTHIAZIDE 12.5MG; IRBESARTAN 300MG · TabletANDA207018-002 · Discontinued

HYDROCHLOROTHIAZIDE 12.5MG; IRBESARTAN 150MG · TabletANDA207018-001 · Discontinued

HYDROCHLOROTHIAZIDE 25MG; IRBESARTAN 300MG · TabletANDA091370-003 · Prescription

HYDROCHLOROTHIAZIDE 12.5MG; IRBESARTAN 150MG · TabletANDA091370-001 · Prescription

HYDROCHLOROTHIAZIDE 12.5MG; IRBESARTAN 300MG · TabletANDA091370-002 · Prescription

HYDROCHLOROTHIAZIDE 12.5MG; IRBESARTAN 300MG · TabletANDA202414-002 · Prescription

HYDROCHLOROTHIAZIDE 12.5MG; IRBESARTAN 150MG · TabletANDA202414-001 · Prescription

HYDROCHLOROTHIAZIDE 25MG; IRBESARTAN 300MG · TabletANDA203036-003 · Discontinued

HYDROCHLOROTHIAZIDE 12.5MG; IRBESARTAN 150MG · TabletANDA203036-001 · Discontinued

HYDROCHLOROTHIAZIDE 12.5MG; IRBESARTAN 300MG · TabletANDA203036-002 · Discontinued

HYDROCHLOROTHIAZIDE 12.5MG; IRBESARTAN 150MG · TabletANDA207896-001 · Prescription

HYDROCHLOROTHIAZIDE 12.5MG; IRBESARTAN 300MG · TabletANDA207896-002 · Prescription

HYDROCHLOROTHIAZIDE 12.5MG; IRBESARTAN 150MG · TabletANDA077446-001 · Prescription

HYDROCHLOROTHIAZIDE 12.5MG; IRBESARTAN 300MG · TabletANDA077446-002 · Prescription

HYDROCHLOROTHIAZIDE 12.5MG; IRBESARTAN 300MG · TabletANDA203630-002 · Prescription

HYDROCHLOROTHIAZIDE 25MG; IRBESARTAN 300MG · TabletANDA203630-003 · Prescription

HYDROCHLOROTHIAZIDE 12.5MG; IRBESARTAN 150MG · TabletANDA203630-001 · Prescription

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA091539.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Brand name: Irbesartan and Hydrochlorothiazide
Active substance: hydrochlorothiazide
Drug class: Renin-inhibitors, Thiazides, plain
Group: ACE inhibitors and sartans
Route: Oral
Dosage form: Tablet
Applicant: Watson Labs Inc
Status: Discontinued
FDA approval: 22 Oct 2012
Application: ANDA091539-002
RxCUI: 5487

Guidelines

Guidelines in cardiology1,851 guidelines in the library

FDA 2024

Entresto Sprinklesacubitril · Capsule, pellets

FDA 2023Filsparisparsentan · Tablet

FDA 2021ValsartanSolution

FDA 2016Olmesartan MedoxomilTablet

FDA 2016Olmesartan Medoxomil and Hydrochlorothiazidehydrochlorothiazide · Tablet

FDA 2016Byvalsonnebivolol hydrochloride · Tablet

FDA 2015Entrestosacubitril · Tablet

FDA 2014Telmisartan and Hydrochlorothiazidehydrochlorothiazide · Tablet

FDA 2014TelmisartanTablet

FDA 2014Telmisartan and Amlodipineamlodipine besylate · Tablet

FDA 2013Epaned Kitenalapril maleate · For solution

FDA 2013Candesartan CilexetilTablet

FDA 2013Amlodipine Besylate and Valsartanamlodipine besylate · Tablet

FDA 2012Candesartan Cilexetil and Hydrochlorothiazidecandesartan cilexetil · Tablet

FDA 2012Irbesartan; Hydrochlorothiazideirbesartan: hydrochlorothiazide · Tablet

FDA 2012Amlodipine Besylate, Valsartan and Hydrochlorothiazideamlodipine besylate · Tablet