Lurasidone Hydrochloride Tablets

SPL v4

SPL

SPL Set ID 0f5f8228-1304-4981-8577-029136627260

Route

ORAL

Published

Effective Date 2023-09-27

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Lurasidone (20 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Imprint: C35 Shape: round Shape: capsule Shape: oval Color: yellow Color: white Size: 6 mm Size: 8 mm Size: 13 mm Size: 12 mm Size: 15 mm Score: 1

Marketing Status

ANDA Active Since 2023-02-01

Description

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

Medication Information

Description

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

Structured Label Content

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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:43:59.227042 · Updated: 2026-03-14T22:18:18.443233