FDA.reportPublic FDA data

odevixibat 0.4 MG Oral Capsule [Bylvay]

RxCUI
2564001
RxNorm name
odevixibat 0.4 MG Oral Capsule [Bylvay]
Display name
odevixibat 0.4 MG Oral Capsule [Bylvay]
Full name
odevixibat 0.4 MG Oral Capsule [Bylvay]
Term type
SBD
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#

UNII substance links page 1 of 1 · 0 matching rows.

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: 2564001
BylvayODEVIXIBATIpsen Biopharmaceuticals, Inc.0935cd31-3251-4a0a-ac23-25ca4be12be92025-12-29Warnings, Adverse reactionsExact identifier
rxcui: 2564001

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-a892de3258faBylvay 400 MCG Oral Capsule [PSN] · odevixibat 0.4 MG Oral Capsule [Bylvay] [SBD] · Bylvay 0.4 MG Oral Capsule [SY] · Bylvay 400 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-ac23-25ca4be12be9Bylvay 400 MCG Oral Capsule [PSN] · odevixibat 0.4 MG Oral Capsule [Bylvay] [SBD] · Bylvay 0.4 MG Oral Capsule [SY] · Bylvay 400 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