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Data / Drug companies / Isosorbide mononitrate

Isosorbide mononitrate: 25 companies and 62 products in the FDA NDC directory

Isosorbide mononitrate is listed in the FDA National Drug Code Directory by 25 companies, with 62 products in commercial distribution. 55 of the products (88.7%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, extended release; tablet, and the newest product started marketing on October 30, 2026.

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Companies listing it
25
Products
62
Generic (ANDA) products
55 (88.7%)
Application numbers
10
Routes
Oral
openFDA record search
api.fda.gov

Companies that list isosorbide mononitrate

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

CompanyProductsMain dosage formsMain marketing categoryNewest product started
A-S Medication Solutions5tablet, extended releaseGeneric drugs (ANDA)November 7, 2022
Coupler LLC5tablet; tablet, extended releaseGeneric drugs (ANDA)July 6, 2026
AiPing Pharmaceutical, Inc.3tablet, extended releaseGeneric drugs (ANDA)October 30, 2026
Aphena Pharma Solutions - Tennessee, LLC3tablet, extended releaseGeneric drugs (ANDA)November 13, 2018
Aurobindo Pharma Limited3tablet, extended releaseGeneric drugs (ANDA)November 7, 2022
Bryant Ranch Prepack3tablet, extended releaseGeneric drugs (ANDA)November 13, 2018
Chartwell RX, LLC3tablet, extended releaseGeneric drugs (ANDA)November 15, 2018
Edenbridge Pharmaceuticals LLC.3tablet, extended releaseGeneric drugs (ANDA)November 15, 2018
Golden State Medical Supply, Inc.3tablet, extended releaseGeneric drugs (ANDA)November 5, 2018
Ingenus Pharmaceuticals, LLC3tablet, extended releaseGeneric drugs (ANDA)November 13, 2018
Shandong New Time Pharmaceutical Co., Ltd.3tablet, extended releaseGeneric drugs (ANDA)February 8, 2024
Torrent Pharmaceuticals Limited3tablet, extended releaseGeneric drugs (ANDA)June 3, 2011
Actavis Pharma, Inc.2tabletGeneric drugs (ANDA)October 30, 1998
American Health Packaging2tablet, extended releaseGeneric drugs (ANDA)June 10, 2024
Ani Pharmaceuticals, Inc.2tabletGeneric drugs (ANDA)March 27, 2026
Cardinal Health 107, LLC2tablet, extended releaseGeneric drugs (ANDA)January 5, 2015
Genus Lifesciences2tabletGeneric drugs (ANDA)April 9, 2026
Lannett Company, Inc.2tabletAuthorized generics (NDA)June 30, 1993
Major Pharmaceuticals2tablet, extended releaseGeneric drugs (ANDA)January 5, 2015
NCS HealthCare of Ky, LLC DBA Vangard Labs2tablet, extended releaseGeneric drugs (ANDA)June 3, 2011
Omnivium Pharmaceuticals LLC.2tabletAuthorized generics (NDA)May 2, 2024
Northwind Health Company, LLC1tablet, extended releaseGeneric drugs (ANDA)March 18, 2022
NuCare Pharmaceuticals,Inc.1tablet, extended releaseGeneric drugs (ANDA)January 5, 2017
Proficient Rx LP1tabletAuthorized generics (NDA)June 30, 1993
Remedyrepack Inc.1tablet, extended releaseGeneric drugs (ANDA)December 3, 2020

Dosage forms

Dosage formProductsShare
Tablet, extended release4877.4%
Tablet1422.6%

Marketing categories

Marketing categoryProductsShare
Generic drugs (ANDA)5588.7%
Authorized generics (NDA)711.3%

Pharmacologic classes

ClassProducts
Nitrate Vasodilator62

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