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Data / Drug companies / Mesalamine

Mesalamine: 41 companies and 64 products in the FDA NDC directory

Mesalamine is listed in the FDA National Drug Code Directory by 41 companies, with 64 products in commercial distribution. 55 of the products (85.9%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, delayed release; capsule, extended release; suppository, and the newest product started marketing on September 1, 2026.

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Companies listing it
41
Products
64
Generic (ANDA) products
55 (85.9%)
Application numbers
34
Routes
Oral, Rectal
Brand names
Pentasa, Lialda, Apriso, Canasa, Rowasa
openFDA record search
api.fda.gov

Companies that list mesalamine

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

CompanyProductsMain dosage formsMain marketing categoryNewest product started
American Health Packaging4tablet, delayed release; capsule, extended releaseGeneric drugs (ANDA)September 6, 2022
Takeda Pharmaceuticals America, Inc.4tablet, delayed release; capsuleNew drug applications (NDA)August 29, 2017
Zydus Lifesciences Limited4tablet, delayed release; suppositoryGeneric drugs (ANDA)August 13, 2021
Bryant Ranch Prepack3kit; suppositoryGeneric drugs (ANDA)June 5, 2019
Bryant Ranch Prepack3tablet, delayed release; suspensionGeneric drugs (ANDA)June 3, 2023
Camber Pharmaceuticals, Inc.3capsule, extended release; tablet, delayed releaseGeneric drugs (ANDA)August 13, 2025
Padagis Israel Pharmaceuticals Ltd3kit; enemaGeneric drugs (ANDA)August 2, 2018
Zydus Pharmaceuticals USA Inc.3tablet, delayed release; capsule, extended releaseGeneric drugs (ANDA)August 13, 2021
Golden State Medical Supply, Inc.2tablet, delayed release; capsule, extended releaseGeneric drugs (ANDA)June 6, 2023
Sandoz Inc2capsule, extended releaseGeneric drugs (ANDA)July 21, 2026
Sun Pharmaceutical Industries, Inc.2capsule, extended release; tablet, delayed releaseGeneric drugs (ANDA)May 13, 2022
Teva Pharmaceuticals USA, Inc.2capsule, extended release; capsule, delayed releaseAuthorized generics (NDA)January 5, 2021
Actavis Pharma, Inc.1suppositoryGeneric drugs (ANDA)April 23, 2021
Actavis Pharma, Inc.1tablet, delayed releaseGeneric drugs (ANDA)March 26, 2018
Alembic Pharmaceuticals Inc.1capsule, extended releaseGeneric drugs (ANDA)November 3, 2022
Alembic Pharmaceuticals Limited1capsule, extended releaseGeneric drugs (ANDA)November 3, 2022
Allergan, Inc.1suppositoryNew drug applications (NDA)January 5, 2001
Amneal Pharmaceuticals LLC1tablet, delayed releaseGeneric drugs (ANDA)February 19, 2025
Ani Pharmaceuticals, Inc.1enemaAuthorized generics (NDA)May 13, 2016
Ani Pharmaceuticals, Inc.1suspensionGeneric drugs (ANDA)May 14, 2026
Ascend Laboratories, LLC1capsule, extended releaseGeneric drugs (ANDA)July 16, 2021
Aurobindo Pharma Limited1capsule, extended releaseGeneric drugs (ANDA)March 31, 2023
AvKARE1tablet, delayed releaseGeneric drugs (ANDA)September 25, 2024
AvPAK1capsule, extended releaseGeneric drugs (ANDA)January 16, 2023
Chartwell RX, LLC1tablet, delayed releaseGeneric drugs (ANDA)June 3, 2023
Encube Ethicals, Inc.1suspensionGeneric drugs (ANDA)June 1, 2023
Ingenus Pharmaceuticals, LLC1capsule, extended releaseGeneric drugs (ANDA)September 23, 2024
KLM Laboratories Private Limited1suspensionGeneric drugs (ANDA)September 1, 2026
Lannett Company, Inc.1tablet, delayed releaseGeneric drugs (ANDA)June 3, 2023
Major Pharmaceuticals1tablet, delayed releaseGeneric drugs (ANDA)June 19, 2017
Mylan Pharmaceuticals Inc.1capsule, extended releaseGeneric drugs (ANDA)November 26, 2019
Nordic Pharma, Inc.1suppositoryGeneric drugs (ANDA)June 24, 2019
NorthStar Rx LLC1suppositoryGeneric drugs (ANDA)August 25, 2021
NorthStar RxLLC1tablet, delayed releaseGeneric drugs (ANDA)December 1, 2024
Nuvaila Limited1tablet, delayed releaseGeneric drugs (ANDA)July 1, 2026
Rising Pharma Holdings, Inc.1suppositoryGeneric drugs (ANDA)April 14, 2025
Salix Pharmaceuticals, Inc.1capsule, extended releaseNew drug applications (NDA)October 31, 2008
Teva Pharmaceuticals, Inc.1tablet, delayed releaseGeneric drugs (ANDA)August 22, 2024
Upsher-Smith Laboratories, LLC1capsule, extended releaseGeneric drugs (ANDA)June 6, 2023
Viatris Specialty LLC1suspensionNew drug applications (NDA)March 24, 2016
Zydus Pharmaceuticals USA Inc.1suppositoryGeneric drugs (ANDA)February 14, 2020

Dosage forms

Dosage formProductsShare
Tablet, delayed release2234.4%
Capsule, extended release1828.1%
Suppository914.1%
Suspension57.8%
Kit46.2%
Enema23.1%
Capsule, delayed release23.1%
Capsule23.1%

Marketing categories

Marketing categoryProductsShare
Generic drugs (ANDA)5585.9%
New drug applications (NDA)69.4%
Authorized generics (NDA)34.7%

Pharmacologic classes

ClassProducts
Aminosalicylate60

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.