FDA.reportPublic FDA data

Lybalvi (olanzapine 20 MG / samidorphan 10 MG) Oral Tablet

RxCUI
2570407
RxNorm name
Lybalvi (olanzapine 20 MG / samidorphan 10 MG) Oral Tablet
Display name
Lybalvi (olanzapine 20 MG / samidorphan 10 MG) Oral Tablet
Full name
Lybalvi (olanzapine 20 MG / samidorphan 10 MG) Oral Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:53

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LYBALVIOLANZAPINE AND SAMIDORPHAN L-MALATEAlkermes, Inc.32ffddd1-4e2b-45d9-9b36-bb730167ec802026-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2570407

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
32ffddd1-4e2b-45d9-9b36-bb730167ec80LYBALVI 20 MG / 10 MG Oral Tablet [PSN] · olanzapine 20 MG / samidorphan 10 MG Oral Tablet [Lybalvi] [SBD] · Lybalvi (olanzapine 20 MG / samidorphan 10 MG (as samidorphan L-malate 13.6 MG)) Oral Tablet [SY] · Lybalvi (olanzapine 20 MG / samidorphan 10 MG) Oral Tablet [SY]416These highlights do not include all the information needed to use LYBALVI ® safely and effectively. See full prescribing information for LYBALVI ® . LYBALVI ® (olanzapine and samidorphan) tablets, for oral use Initial U.S. Approval: 202120260131