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Data / Drug companies / Lurasidone hydrochloride

Lurasidone hydrochloride: 28 companies and 135 products in the FDA NDC directory

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

Lurasidone hydrochloride is listed in the FDA National Drug Code Directory by 28 companies, with 135 products in commercial distribution. 130 of the products (96.3%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated; tablet, coated; tablet, and the newest product started marketing on March 2, 2026.

The request: Get every company that lists lurasidone hydrochloride in the FDA NDC directory, with headquarters, website and number of employees. $10 of work on sign-up, no card.

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Companies listing it
28
Products
135
Generic (ANDA) products
130 (96.3%)
Application numbers
17
Routes
Oral
Brand names
Latuda
openFDA record search
api.fda.gov

Companies that list lurasidone hydrochloride

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

CompanyProductsMain dosage formsMain marketing categoryNewest product started
Major Pharmaceuticals10tablet, film coatedGeneric drugs (ANDA)February 9, 2023
Remedyrepack Inc.6tablet, film coated; tabletGeneric drugs (ANDA)February 3, 2026
Torrent Pharmaceuticals Limited6tablet, film coatedGeneric drugs (ANDA)March 2, 2026
Accord Healthcare Inc.5tablet, film coatedGeneric drugs (ANDA)February 20, 2023
Alembic Pharmaceuticals Inc.5tablet, film coatedGeneric drugs (ANDA)January 24, 2023
Alembic Pharmaceuticals Limited5tablet, film coatedGeneric drugs (ANDA)January 24, 2023
Amneal Pharmaceuticals LLC5tablet, coatedGeneric drugs (ANDA)January 2, 2023
Amneal Pharmaceuticals of New York LLC5tablet, coatedGeneric drugs (ANDA)July 5, 2024
Ascend Laboratories, LLC5tablet, film coatedGeneric drugs (ANDA)January 4, 2023
Aurobindo Pharma Limited5tabletGeneric drugs (ANDA)March 10, 2023
Camber Pharmaceuticals, Inc.5tablet, film coatedGeneric drugs (ANDA)August 21, 2024
Cipla USA Inc.5tablet, film coatedGeneric drugs (ANDA)February 20, 2023
Dr. Reddy's Laboratories Inc.5tablet, film coatedGeneric drugs (ANDA)February 20, 2023
Exelan Pharmaceuticals Inc.5tablet, film coatedGeneric drugs (ANDA)February 20, 2023
Heritage Pharmaceuticals Inc. D/B/A Avet Pharmaceuticals Inc.5tablet, film coatedGeneric drugs (ANDA)October 19, 2023
Lupin Pharmaceuticals, Inc.5tabletGeneric drugs (ANDA)February 20, 2023
Macleods Pharmaceuticals Limited5tablet, film coatedGeneric drugs (ANDA)June 9, 2023
Novadoz Pharmaceuticals LLC5tablet, film coatedGeneric drugs (ANDA)February 9, 2023
Sumitomo Pharma America, Inc.5tablet, film coatedNew drug applications (NDA)July 12, 2013
Sun Pharmaceutical Industries, Inc.5tabletGeneric drugs (ANDA)February 20, 2023
Zydus Lifesciences Limited5tablet, coatedGeneric drugs (ANDA)February 1, 2023
Zydus Pharmaceuticals USA Inc.5tablet, coatedGeneric drugs (ANDA)February 1, 2023
American Health Packaging4tablet, film coatedGeneric drugs (ANDA)July 3, 2023
NorthStar RxLLC4tablet, film coatedGeneric drugs (ANDA)April 8, 2025
A-S Medication Solutions3tablet, film coatedGeneric drugs (ANDA)February 20, 2023
Coupler LLC3tablet, film coated; tabletGeneric drugs (ANDA)February 12, 2026
Golden State Medical Supply, Inc.3tablet, film coatedGeneric drugs (ANDA)February 28, 2023
Proficient Rx LP1tabletGeneric drugs (ANDA)March 10, 2023

Dosage forms

Dosage formProductsShare
Tablet, film coated9771.9%
Tablet, coated2014.8%
Tablet1813.3%

Marketing categories

Marketing categoryProductsShare
Generic drugs (ANDA)13096.3%
New drug applications (NDA)53.7%

Pharmacologic classes

ClassProducts
Atypical Antipsychotic135

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.