Quick answers
- What is Lurasidone hydrochloride used for?
- The FDA-approved label (Latuda, Sumitomo Pharma America, Inc., January 31, 2025) says: “LATUDA is indicated for: Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia […]. Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) […]. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Lurasidone hydrochloride have a boxed warning?
- Yes. The FDA label for Latuda has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Lurasidone hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Lurasidone hydrochloride been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started January 18, 2024 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Lurasidone hydrochloride?
- 29 companies list prescription products of Lurasidone hydrochloride in the FDA NDC Directory, including Major Pharmaceuticals, Torrent Pharmaceuticals Limited and Remedyrepack Inc..
What Lurasidone hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
LATUDA is indicated for: Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia […]. Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) […]. …
— FDA label: Latuda, Sumitomo Pharma America, Inc., effective January 31, 2025. Read the full label on DailyMed →
The FDA has 37 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
36 of 37 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet, coated · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 136 in the FDA NDC Directory |
| Brand names | Latuda |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| lurasidone hydrochloride 120 mg tablet | Generic | $0.4958 per tablet |
| lurasidone hydrochloride 120 mg tablet, coated | Generic | $0.4958 per tablet |
| lurasidone hydrochloride 120 mg tablet, film coated | Generic | $0.4958 per tablet |
| lurasidone hydrochloride 120 mg tablet, film coated | Brand: Latuda | $69.28 per tablet |
| lurasidone hydrochloride 20 mg tablet | Generic | $0.1454 per tablet |
| lurasidone hydrochloride 20 mg tablet, coated | Generic | $0.1454 per tablet |
| lurasidone hydrochloride 20 mg tablet, film coated | Generic | $0.1454 per tablet |
| lurasidone hydrochloride 20 mg tablet, film coated | Brand: Latuda | $46.46 per tablet |
| lurasidone hydrochloride 40 mg tablet | Generic | $0.2123 per tablet |
| lurasidone hydrochloride 40 mg tablet, coated | Generic | $0.2123 per tablet |
| lurasidone hydrochloride 40 mg tablet, film coated | Generic | $0.2123 per tablet |
| lurasidone hydrochloride 40 mg tablet, film coated | Brand: Latuda | $46.92 per tablet |
| lurasidone hydrochloride 60 mg tablet | Generic | $0.2987 per tablet |
| lurasidone hydrochloride 60 mg tablet, coated | Generic | $0.2987 per tablet |
| lurasidone hydrochloride 60 mg tablet, film coated | Generic | $0.2987 per tablet |
| lurasidone hydrochloride 60 mg tablet, film coated | Brand: Latuda | $46.81 per tablet |
| lurasidone hydrochloride 80 mg tablet | Generic | $0.3250 per tablet |
| lurasidone hydrochloride 80 mg tablet, coated | Generic | $0.3250 per tablet |
| lurasidone hydrochloride 80 mg tablet, film coated | Generic | $0.3250 per tablet |
| lurasidone hydrochloride 80 mg tablet, film coated | Brand: Latuda | $46.37 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Major Pharmaceuticals10 products
- Torrent Pharmaceuticals Limited6 products
- Remedyrepack Inc.6 products
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.5 products
- Amneal Pharmaceuticals of New York LLC5 products
- Amneal Pharmaceuticals LLC5 products
- Ascend Laboratories, LLC5 products
- Lupin Pharmaceuticals, Inc.5 products
- Zydus Lifesciences Limited5 products
- Novadoz Pharmaceuticals LLC5 products
- Exelan Pharmaceuticals Inc.5 products
- Accord Healthcare Inc.5 products
- Macleods Pharmaceuticals Limited5 products
- Sun Pharmaceutical Industries, Inc.5 products
- Aurobindo Pharma Limited5 products
- Cipla USA Inc.5 products
- Camber Pharmaceuticals, Inc.5 products
- Dr.Reddys Laboratories Inc5 products
- Alembic Pharmaceuticals Limited5 products
- Sumitomo Pharma America, Inc.5 products
- Alembic Pharmaceuticals Inc.5 products
- Zydus Pharmaceuticals USA Inc.5 products
- American Health Packaging4 products
- NorthStar RxLLC4 products
- Golden State Medical Supply, Inc.3 products
- Coupler LLC3 products
- A-S Medication Solutions3 products
- Proficient Rx LP1 product
- Direct_Rx1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA200603 LATUDA | Sunovion Pharms Inc | October 28, 2010 | 27, latest January 22, 2025 2025: Labeling · 2019: Labeling · 2018: Efficacy |
Generic approvals (16)
- ANDA208002Amneal Pharms Co · January 3, 2019
- ANDA208028Invagen Pharms · January 3, 2019
- ANDA208031Lupin · January 3, 2019
- ANDA208049Accord Hlthcare · January 3, 2019
- ANDA208055Torrent · January 3, 2019
- ANDA208066Sun Pharm · January 4, 2019
- ANDA208052Zydus Pharms · March 19, 2019
- ANDA208058Heritage Pharma Avet · September 4, 2019
- ANDA212091Chartwell Rx · December 28, 2020
- ANDA213248Alembic · May 13, 2021
- ANDA208047DR Reddys · August 24, 2021
- ANDA208037Msn · September 9, 2022
- ANDA212244Alkem Labs Ltd · December 13, 2022
- ANDA208045Aurobindo Pharma Ltd · March 10, 2023
- ANDA212124Macleods Pharms · June 9, 2023
- ANDA218174Annora Pharma · August 21, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
January 18, 2024 · Class II · Completed · D-0266-2024
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadr — SUN PHARMACEUTICAL INDUSTRIES INC
-
January 18, 2024 · Class II · Completed · D-0267-2024
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dad — SUN PHARMACEUTICAL INDUSTRIES INC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Latuda, Sumitomo Pharma America, Inc., effective January 31, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →