Lurasidone Hydrochloride Tablet, Coated
FDA Label NDC 70771-1735

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zydus Lifesciences Limited for the product Lurasidone Hydrochloride (NDC 70771-1735). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Package Label.Principal Display Panel

NDC 70771-1734-3

Lurasidone hydrochloride tablets, 20 mg

30 tablets

Rx only

20 mg (8e4af9ec 5db8 4423 A331 561613cdfc3e 01)

20 mg (8e4af9ec 5db8 4423 A331 561613cdfc3e 01)

NDC 70771-1735-9

Lurasidone hydrochloride tablets, 40 mg

90 tablets

Rx only

40 mg (8e4af9ec 5db8 4423 A331 561613cdfc3e 02)

40 mg (8e4af9ec 5db8 4423 A331 561613cdfc3e 02)

NDC 70771-1736-3

Lurasidone hydrochloride tablets, 60 mg

30 tablets

Rx only

60 mg (8e4af9ec 5db8 4423 A331 561613cdfc3e 03)

60 mg (8e4af9ec 5db8 4423 A331 561613cdfc3e 03)

NDC 70771-1737-3

Lurasidone hydrochloride tablets, 80 mg

30 tablets

Rx only

80 mg (8e4af9ec 5db8 4423 A331 561613cdfc3e 04)

80 mg (8e4af9ec 5db8 4423 A331 561613cdfc3e 04)

NDC 70771-1738-3

Lurasidone hydrochloride tablets, 120 mg

30 tablets

Rx only

120 mg (8e4af9ec 5db8 4423 A331 561613cdfc3e 05)

120 mg (8e4af9ec 5db8 4423 A331 561613cdfc3e 05)

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