Lurasidone Hydrochloride

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 55 observed states.

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 55 observed states.

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Additional Listing Data#

Finished product

Yes

Brand name base

Lurasidone Hydrochloride

Listing expiration

2026-12-31

Active Ingredients#

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

DailyMed Product Concepts#

DailyMed Package Descriptions#

Related Records#

• All packages for product NDC 70518-4491
• DailyMed label: Lurasidone Hydrochloride
• FDA application 218174
• Company: REMEDYREPACK INC.
• Search ingredient/name matches

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#