lurasidone hydrochloride

Basic Information

Product Name

FDA Product Code

33342-421

Regulatory Information

NDC Product Code

33342-421

Application Number

ANDA212124

Marketing Category

C73584

Effective Date

June 26, 2023

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use LURASIDONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for LURASIDONE HYDROCHLORIDE TABLETS. LURASIDONE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 2010

Labeling Type

Human Prescription Drug Label

Version Number

Active Ingredients

MANNITOL

Code: 3OWL53L36A

Class Code: IACT

LURASIDONE HYDROCHLORIDE

Quantity: 60 mg in 1 1

Code: O0P4I5851I

Class Code: ACTIB

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POLYETHYLENE GLYCOL 8000

Code: Q662QK8M3B

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

LURASIDONE

Code: 22IC88528T

Basic Information

Regulatory Information

Company Information

Active Ingredients

MANNITOL

CROSCARMELLOSE SODIUM

HYPROMELLOSES

STARCH, CORN

MAGNESIUM STEARATE

POLYETHYLENE GLYCOL 8000

TITANIUM DIOXIDE

Active Moieties

LURASIDONE