FDA.reportPublic FDA data

olanzapine 5 MG / samidorphan 10 MG Oral Tablet [Lybalvi]

RxCUI
2570398
RxNorm name
olanzapine 5 MG / samidorphan 10 MG Oral Tablet [Lybalvi]
Display name
olanzapine 5 MG / samidorphan 10 MG Oral Tablet [Lybalvi]
Full name
olanzapine 5 MG / samidorphan 10 MG Oral Tablet [Lybalvi]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:53

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

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: 2570398

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 5 MG / 10 MG Oral Tablet [PSN] · olanzapine 5 MG / samidorphan 10 MG Oral Tablet [Lybalvi] [SBD] · Lybalvi (olanzapine 5 MG / samidorphan 10 MG (as samidorphan L-malate 13.6 MG)) Oral Tablet [SY] · Lybalvi (olanzapine 5 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