FDA.reportPublic FDA data

odevixibat (as odevixibat sesquihydrate) 1200 MCG Oral Capsule

RxCUI
2564003
RxNorm name
odevixibat (as odevixibat sesquihydrate) 1200 MCG Oral Capsule
Display name
odevixibat (as odevixibat sesquihydrate) 1200 MCG Oral Capsule
Full name
odevixibat (as odevixibat sesquihydrate) 1200 MCG Oral Capsule
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:48

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BYLVAYODEVIXIBATAlbireo Pharma, Inc.151f1d3e-2bf4-47ce-b1be-a892de3258fa2025-12-31Warnings, Adverse reactionsExact identifier
rxcui: 2564003
BylvayODEVIXIBATIpsen Biopharmaceuticals, Inc.0935cd31-3251-4a0a-ac23-25ca4be12be92025-12-29Warnings, Adverse reactionsExact identifier
rxcui: 2564003

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
151f1d3e-2bf4-47ce-b1be-a892de3258faodevixibat 1200 MCG Oral Capsule [PSN] · odevixibat 1.2 MG Oral Capsule [SCD] · odevixibat (as odevixibat sesquihydrate) 1200 MCG Oral Capsule [SY] · odevixibat 1200 MCG Oral Capsule [SY]49These highlights do not include all the information needed to use BYLVAY safely and effectively. See full prescribing information for BYLVAY. BYLVAY (odevixibat) capsules, for oral use BYLVAY (odevixibat) oral pellets Initial U.S. Approval: 202120251231
0935cd31-3251-4a0a-ac23-25ca4be12be9odevixibat 1200 MCG Oral Capsule [PSN] · odevixibat 1.2 MG Oral Capsule [SCD] · odevixibat (as odevixibat sesquihydrate) 1200 MCG Oral Capsule [SY] · odevixibat 1200 MCG Oral Capsule [SY]44These highlights do not include all the information needed to use BYLVAY safely and effectively. See full prescribing information for BYLVAY. BYLVAY (odevixibat) capsules, for oral use BYLVAY (odevixibat) oral pellets Initial U.S. Approval: 202120251229