Medical emergency?Emergency? Call 911. Nearest emergency roomsNearest ERs

Español Near me My list Help
US Patient GuideUSA
Surprise me
Prescription medicine · generic available

Irbesartan

Brand names: Avapro

Drug class: Angiotensin 2 Receptor Blocker

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

YesBoxed warning
None listedFDA shortage list
6Recalls (FDA reports)
24Companies
1997First FDA approval on file

Quick answers

What is Irbesartan used for?
The FDA-approved label (Avapro, Sanofi-Aventis U.S. LLC, August 24, 2026) says: “AVAPRO is an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Irbesartan have a boxed warning?
Yes. The FDA label for Avapro has a boxed warning (“WARNING: FETAL TOXICITY”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
Is there a shortage of Irbesartan?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Irbesartan been recalled?
FDA enforcement reports list 6 recalls of products of this medicine; the newest started July 18, 2022 (Class II). A recall usually concerns specific lots, not every product.
Who makes Irbesartan?
24 companies list prescription products of Irbesartan in the FDA NDC Directory, including Bryant Ranch Prepack, Camber Pharmaceuticals, Inc. and Remedyrepack Inc..

What Irbesartan is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

AVAPRO is an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. …

— FDA label: Avapro, Sanofi-Aventis U.S. LLC, effective August 24, 2026. Read the full label on DailyMed →

The FDA has 43 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Heart failureHigh blood pressureStroke

Related medical specialties

CardiologyNeurology

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

This label has a boxed warning. Its heading: WARNING: FETAL TOXICITY. Read it on the full label →

43 of 43 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsTablet · Tablet, film coated
RouteOral
Prescription products83 in the FDA NDC Directory
Brand namesAvapro

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Irbesartan, by strength and form
Strength and formGeneric or brandPharmacies pay
irbesartan 150 mg
tablet		 Generic $0.1090 per tablet
irbesartan 150 mg
tablet, film coated		 Generic $0.1090 per tablet
irbesartan 150 mg
tablet, film coated		 Brand: Avapro $7.34 per tablet
irbesartan 300 mg
tablet		 Generic $0.1647 per tablet
irbesartan 300 mg
tablet, film coated		 Generic $0.1647 per tablet
irbesartan 300 mg
tablet, film coated		 Brand: Avapro $8.80 per tablet
irbesartan 75 mg
tablet		 Generic $0.0843 per tablet
irbesartan 75 mg
tablet, film coated		 Generic $0.0843 per tablet

NADAC list of November 4, 2026; these prices took effect between October 21, 2026 and October 28, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA020757
AVAPRO		 Sanofi Aventis UsSeptember 30, 1997 52, latest July 24, 2026
2026: Labeling · 2025: Labeling · 2021: Labeling

Generic approvals (13)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. July 18, 2022 · Class II · Terminated · D-1293-2022

    Failed dissolution specifications.

    Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-448-90 — Jubilant Cadista Pharmaceuticals, Inc.

  2. July 18, 2022 · Class II · Terminated · D-1294-2022

    Failed Dissolution Specifications

    Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-447-90 — Jubilant Cadista Pharmaceuticals, Inc.

  3. October 12, 2021 · Class II · Terminated · D-0086-2022

    CGMP Deviations: impurity N-nitrosoirbesartan detected in API

    Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx only — Lupin Pharmaceuticals Inc.

  4. October 12, 2021 · Class II · Terminated · D-0087-2022

    CGMP Deviations: impurity N-nitrosoirbesartan detected in API

    Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) bottles, Rx only — Lupin Pharmaceuticals Inc.

  5. October 12, 2021 · Class II · Terminated · D-0088-2022

    CGMP Deviations: impurity N-nitrosoirbesartan detected in API

    Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only — Lupin Pharmaceuticals Inc.

  6. January 18, 2019 · Class II · Completed · D-0409-2019

    CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

    Irbesartan Tablets 300 mg 90 count Rx only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Xunqiao, Linhai, Zhejiang 317024 China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 NDC 43547-376-09 — Prinston Pharmaceutical Inc

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)153666, 153667, 200094, 200095, 200096
SPL set ID of the quoted label7885b2a8-be4e-48ab-8113-4e6ab791eb98
FDA labels (SPL)43
FDA applicationsNDA020757, 13 ANDA
Active ingredients (FDA)IRBESARTAN

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Avapro, Sanofi-Aventis U.S. LLC, effective August 24, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

Report an error → · Information for medicine makers