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Data / Drug companies / Mirtazapine

Mirtazapine: 42 companies and 144 products in the FDA NDC directory

Mirtazapine is listed in the FDA National Drug Code Directory by 42 companies, with 144 products in commercial distribution. 139 of the products (96.5%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated; tablet, orally disintegrating; tablet, and the newest product started marketing on August 21, 2026.

SpecStream is the live web data engine for teams and agents. It reads the National Drug Code Directory that FDA publishes, and this page is that reading. Ask for the companies that make a drug, a class or a dosage form, with their headquarters, website and size added from the web, and new listings and discontinued products arrive in your sheet, CRM, Slack or agent as FDA posts them.

Companies listing it
42
Products
144
Generic (ANDA) products
139 (96.5%)
Application numbers
11
Routes
Oral
Brand names
Remeronsoltab, Remeron
openFDA record search
api.fda.gov

Companies that list mirtazapine

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

CompanyProductsMain dosage formsMain marketing categoryNewest product started
Bryant Ranch Prepack11tablet, film coated; tabletGeneric drugs (ANDA)August 7, 2022
Remedyrepack Inc.9tablet, film coated; tabletGeneric drugs (ANDA)January 18, 2026
Aphena Pharma Solutions - Tennessee, LLC8tablet, film coated; tabletGeneric drugs (ANDA)September 1, 2023
Aurobindo Pharma Limited7tablet, film coated; tablet, orally disintegratingGeneric drugs (ANDA)February 28, 2006
Rising Pharma Holdings, Inc.7tablet, film coated; tablet, orally disintegratingGeneric drugs (ANDA)February 28, 2006
Coupler LLC6tablet, film coatedGeneric drugs (ANDA)August 21, 2026
A-S Medication Solutions5tablet, film coatedGeneric drugs (ANDA)October 2, 2025
Bryant Ranch Prepack5tablet; tablet, film coatedGeneric drugs (ANDA)August 17, 2009
Organon LLC5tablet, orally disintegrating; tablet, film coatedNew drug applications (NDA)June 1, 2021
Aurolife Pharma, LLC4tablet, film coatedGeneric drugs (ANDA)August 17, 2009
Camber Pharmaceuticals, Inc.4tablet, film coatedGeneric drugs (ANDA)October 2, 2025
Cardinal Health 107, LLC4tablet, film coated; tablet, orally disintegratingGeneric drugs (ANDA)July 10, 2026
NCS HealthCare of Ky, LLC DBA Vangard Labs4tablet, film coatedGeneric drugs (ANDA)May 14, 2026
Prasco Laboratories4tablet, film coatedGeneric drugs (ANDA)September 1, 2023
Proficient Rx LP4tablet, film coatedGeneric drugs (ANDA)August 17, 2009
Sun Pharmaceutical Industries, Inc.4tabletGeneric drugs (ANDA)April 22, 2004
XLCare Pharmaceuticals, Inc.4tablet, film coatedGeneric drugs (ANDA)October 2, 2025
American Health Packaging3tablet, film coatedGeneric drugs (ANDA)January 5, 2006
Apotex Corp.3tablet, film coatedGeneric drugs (ANDA)August 22, 2007
Bryant Ranch Prepack3tablet; tablet, film coatedGeneric drugs (ANDA)August 17, 2009
Golden State Medical Supply, Inc.3tablet, film coatedGeneric drugs (ANDA)June 19, 2003
Mylan Institutional Inc.3tablet, film coatedGeneric drugs (ANDA)August 1, 2003
Mylan Pharmaceuticals Inc.3tablet, film coatedGeneric drugs (ANDA)June 20, 2003
NuCare Pharmaceuticals,Inc.3tablet, film coatedGeneric drugs (ANDA)October 22, 2004
Preferred Pharmaceuticals Inc.3tablet, film coatedGeneric drugs (ANDA)June 14, 2023
Safecor Health, LLC3tablet, film coatedGeneric drugs (ANDA)February 5, 2026
Square Pharmaceuticals Limited3tablet, orally disintegratingGeneric drugs (ANDA)November 15, 2022
Viona Pharmaceuticals Inc3tablet, orally disintegratingGeneric drugs (ANDA)August 7, 2022
AvKARE2tablet; tablet, film coatedGeneric drugs (ANDA)May 20, 2025
McKesson Corporation DBA Sky Packaging2tablet, film coatedGeneric drugs (ANDA)August 22, 2007
Advanced Rx of Tennessee, LLC1tablet, film coatedGeneric drugs (ANDA)April 7, 2023
American Health Packaging1tablet, film coatedGeneric drugs (ANDA)August 29, 2022
Ani Pharmaceuticals, Inc.1tablet, film coatedGeneric drugs (ANDA)May 14, 2026
Aphena Pharma Solutions - Tennessee, LLC1tablet, film coatedGeneric drugs (ANDA)August 22, 2007
Atlantic Biologicals Corp.1tablet, film coatedGeneric drugs (ANDA)August 17, 2009
Direct RX1tablet, film coatedGeneric drugs (ANDA)May 10, 2022
Direct_Rx1tablet, film coatedGeneric drugs (ANDA)June 2, 2025
Major Pharmaceuticals1tablet, film coatedGeneric drugs (ANDA)August 22, 2007
NorthStar RxLLC1tablet, film coatedGeneric drugs (ANDA)April 1, 2025
Proficient Rx LP1tablet, film coatedGeneric drugs (ANDA)October 22, 2004
Redpharm Drug1tablet, film coatedGeneric drugs (ANDA)April 1, 2025
Unit Dose Solutions, Inc.1tablet, film coatedGeneric drugs (ANDA)August 17, 2009

Dosage forms

Dosage formProductsShare
Tablet, film coated11177.1%
Tablet, orally disintegrating1812.5%
Tablet1510.4%

Marketing categories

Marketing categoryProductsShare
Generic drugs (ANDA)13996.5%
New drug applications (NDA)53.5%

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.