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.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Major Pharmaceuticals | 10 | tablet, film coated | Generic drugs (ANDA) | February 9, 2023 |
| Remedyrepack Inc. | 6 | tablet, film coated; tablet | Generic drugs (ANDA) | February 3, 2026 |
| Torrent Pharmaceuticals Limited | 6 | tablet, film coated | Generic drugs (ANDA) | March 2, 2026 |
| Accord Healthcare Inc. | 5 | tablet, film coated | Generic drugs (ANDA) | February 20, 2023 |
| Alembic Pharmaceuticals Inc. | 5 | tablet, film coated | Generic drugs (ANDA) | January 24, 2023 |
| Alembic Pharmaceuticals Limited | 5 | tablet, film coated | Generic drugs (ANDA) | January 24, 2023 |
| Amneal Pharmaceuticals LLC | 5 | tablet, coated | Generic drugs (ANDA) | January 2, 2023 |
| Amneal Pharmaceuticals of New York LLC | 5 | tablet, coated | Generic drugs (ANDA) | July 5, 2024 |
| Ascend Laboratories, LLC | 5 | tablet, film coated | Generic drugs (ANDA) | January 4, 2023 |
| Aurobindo Pharma Limited | 5 | tablet | Generic drugs (ANDA) | March 10, 2023 |
| Camber Pharmaceuticals, Inc. | 5 | tablet, film coated | Generic drugs (ANDA) | August 21, 2024 |
| Cipla USA Inc. | 5 | tablet, film coated | Generic drugs (ANDA) | February 20, 2023 |
| Dr. Reddy's Laboratories Inc. | 5 | tablet, film coated | Generic drugs (ANDA) | February 20, 2023 |
| Exelan Pharmaceuticals Inc. | 5 | tablet, film coated | Generic drugs (ANDA) | February 20, 2023 |
| Heritage Pharmaceuticals Inc. D/B/A Avet Pharmaceuticals Inc. | 5 | tablet, film coated | Generic drugs (ANDA) | October 19, 2023 |
| Lupin Pharmaceuticals, Inc. | 5 | tablet | Generic drugs (ANDA) | February 20, 2023 |
| Macleods Pharmaceuticals Limited | 5 | tablet, film coated | Generic drugs (ANDA) | June 9, 2023 |
| Novadoz Pharmaceuticals LLC | 5 | tablet, film coated | Generic drugs (ANDA) | February 9, 2023 |
| Sumitomo Pharma America, Inc. | 5 | tablet, film coated | New drug applications (NDA) | July 12, 2013 |
| Sun Pharmaceutical Industries, Inc. | 5 | tablet | Generic drugs (ANDA) | February 20, 2023 |
| Zydus Lifesciences Limited | 5 | tablet, coated | Generic drugs (ANDA) | February 1, 2023 |
| Zydus Pharmaceuticals USA Inc. | 5 | tablet, coated | Generic drugs (ANDA) | February 1, 2023 |
| American Health Packaging | 4 | tablet, film coated | Generic drugs (ANDA) | July 3, 2023 |
| NorthStar RxLLC | 4 | tablet, film coated | Generic drugs (ANDA) | April 8, 2025 |
| A-S Medication Solutions | 3 | tablet, film coated | Generic drugs (ANDA) | February 20, 2023 |
| Coupler LLC | 3 | tablet, film coated; tablet | Generic drugs (ANDA) | February 12, 2026 |
| Golden State Medical Supply, Inc. | 3 | tablet, film coated | Generic drugs (ANDA) | February 28, 2023 |
| Proficient Rx LP | 1 | tablet | Generic drugs (ANDA) | March 10, 2023 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated | 97 | 71.9% |
| Tablet, coated | 20 | 14.8% |
| Tablet | 18 | 13.3% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 130 | 96.3% |
| New drug applications (NDA) | 5 | 3.7% |
Pharmacologic classes
| Class | Products |
|---|---|
| Atypical Antipsychotic | 135 |
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.