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Data / Drug companies / Irbesartan and hydrochlorothiazide

Irbesartan and hydrochlorothiazide: 15 companies and 31 products in the FDA NDC directory

Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).

Irbesartan and hydrochlorothiazide is listed in the FDA National Drug Code Directory by 15 companies, with 31 products in commercial distribution. 29 of the products (93.5%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated; tablet, and the newest product started marketing on October 18, 2018.

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Companies listing it
15
Products
31
Generic (ANDA) products
29 (93.5%)
Application numbers
8
Routes
Oral
Brand names
Avalide
openFDA record search
api.fda.gov

Companies that list irbesartan and hydrochlorothiazide

Ranked by number of products. Finished drugs in commercial distribution.

CompanyProductsMain dosage formsMain marketing categoryNewest product started
Alembic Pharmaceuticals Inc.3tablet; tablet, film coatedGeneric drugs (ANDA)May 23, 2016
Alembic Pharmaceuticals Limited3tabletGeneric drugs (ANDA)May 23, 2016
Aurobindo Pharma Limited3tablet, film coatedGeneric drugs (ANDA)March 31, 2016
Bryant Ranch Prepack3tablet; tablet, film coatedGeneric drugs (ANDA)March 1, 2014
Bryant Ranch Prepack2tablet; tablet, film coatedGeneric drugs (ANDA)March 1, 2014
Hikma Pharmaceuticals USA Inc.2tabletGeneric drugs (ANDA)October 15, 2012
Macleods Pharmaceuticals Limited2tablet, film coatedGeneric drugs (ANDA)September 27, 2012
Proficient Rx LP2tablet, film coatedGeneric drugs (ANDA)January 24, 2013
Sanofi-Aventis U.S. LLC2tablet, film coatedNew drug applications (NDA)January 1, 2013
Solco Healthcare US, LLC2tabletGeneric drugs (ANDA)March 1, 2014
Teva Pharmaceuticals USA, Inc.2tablet, film coatedGeneric drugs (ANDA)August 27, 2013
Unichem Pharmaceuticals (USA), Inc.2tablet, film coatedGeneric drugs (ANDA)September 19, 2017
Bryant Ranch Prepack1tablet, film coatedGeneric drugs (ANDA)September 27, 2012
Proficient Rx LP1tabletGeneric drugs (ANDA)March 1, 2014
Remedyrepack Inc.1tabletGeneric drugs (ANDA)October 18, 2018

Dosage forms

Dosage formProductsShare
Tablet, film coated1754.8%
Tablet1445.2%

Marketing categories

Marketing categoryProductsShare
Generic drugs (ANDA)2993.5%
New drug applications (NDA)26.5%

Pharmacologic classes

CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.