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FDA Drug information

Lurasidone hydrochloride

Read time: 1 mins
Marketing start date: 28 Apr 2024
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Summary of product characteristics


Effective Time

20230323

Version

2

Spl Product Data Elements

Lurasidone hydrochloride Lurasidone hydrochloride LURASIDONE HYDROCHLORIDE LURASIDONE CELLULOSE, MICROCRYSTALLINE CITRIC ACID MONOHYDRATE CROSCARMELLOSE SODIUM FERRIC OXIDE YELLOW HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLOXAMER 407 POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED STARCH, CORN TALC TITANIUM DIOXIDE YELLOW TO LIGHT YELLOW ROUND C31 Lurasidone hydrochloride Lurasidone hydrochloride LURASIDONE HYDROCHLORIDE LURASIDONE CELLULOSE, MICROCRYSTALLINE CITRIC ACID MONOHYDRATE CROSCARMELLOSE SODIUM HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLOXAMER 407 POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED STARCH, CORN TALC TITANIUM DIOXIDE WHITE TO OFF WHITE ROUND C32 Lurasidone hydrochloride Lurasidone hydrochloride LURASIDONE HYDROCHLORIDE LURASIDONE CELLULOSE, MICROCRYSTALLINE CITRIC ACID MONOHYDRATE CROSCARMELLOSE SODIUM HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLOXAMER 407 POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED STARCH, CORN TALC TITANIUM DIOXIDE WHITE TO OFF WHITE MODIFIED CAPSULE C33 Lurasidone hydrochloride Lurasidone hydrochloride LURASIDONE HYDROCHLORIDE LURASIDONE CELLULOSE, MICROCRYSTALLINE CITRIC ACID MONOHYDRATE CROSCARMELLOSE SODIUM FERRIC OXIDE YELLOW HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLOXAMER 407 POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED STARCH, CORN TALC TITANIUM DIOXIDE YELLOW TO LIGHT YELLOW OVAL C34 Lurasidone hydrochloride Lurasidone hydrochloride LURASIDONE HYDROCHLORIDE LURASIDONE CITRIC ACID MONOHYDRATE CROSCARMELLOSE SODIUM HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED STARCH, CORN POLOXAMER 407 TITANIUM DIOXIDE TALC POLYVINYL ALCOHOL, UNSPECIFIED WHITE TO OFF WHITE OVAL C35

Application Number

ANDA208052

Brand Name

Lurasidone hydrochloride

Generic Name

Lurasidone hydrochloride

Product Ndc

70771-1738

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1734-3 Lurasidone hydrochloride tablets, 20 mg 30 tablets Rx only NDC 70771-1735-9 Lurasidone hydrochloride tablets, 40 mg 90 tablets Rx only NDC 70771-1736-3 Lurasidone hydrochloride tablets, 60 mg 30 tablets Rx only NDC 70771-1737-3 Lurasidone hydrochloride tablets, 80 mg 30 tablets Rx only NDC 70771-1738-3 Lurasidone hydrochloride tablets, 120 mg 30 tablets Rx only 20 mg 40 mg 60 mg 80 mg 120 mg

Drug section

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