FDA.reportPublic FDA data

berotralstat 108 MG Oral Pellet [Orladeyo]

RxCUI
2728878
RxNorm name
berotralstat 108 MG Oral Pellet [Orladeyo]
Display name
berotralstat 108 MG Oral Pellet [Orladeyo]
Full name
berotralstat 108 MG Oral Pellet [Orladeyo]
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#

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OrladeyoBEROTRALSTAT HYDROCHLORIDEBioCryst Pharmaceuticals, Inc.3527ece1-e7e0-40b1-b0c5-6baeb0deabeb2026-02-13Warnings, Adverse reactionsExact identifier
rxcui: 2728878

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
3527ece1-e7e0-40b1-b0c5-6baeb0deabebberotralstat 108 MG Oral Pellet [Orladeyo]SBD8These highlights do not include all the information needed to use ORLADEYO ® safely and effectively. See full prescribing information for ORLADEYO. ORLADEYO (berotralstat) capsules, for oral use ORLADEYO (berotralstat) oral pellets Initial U.S. Approval: 202020260213
3527ece1-e7e0-40b1-b0c5-6baeb0deabebOrladeyo 108 MG Oral PelletSY8These highlights do not include all the information needed to use ORLADEYO ® safely and effectively. See full prescribing information for ORLADEYO. ORLADEYO (berotralstat) capsules, for oral use ORLADEYO (berotralstat) oral pellets Initial U.S. Approval: 202020260213
3527ece1-e7e0-40b1-b0c5-6baeb0deabeborladeyo 108 MG Oral PelletPSN8These highlights do not include all the information needed to use ORLADEYO ® safely and effectively. See full prescribing information for ORLADEYO. ORLADEYO (berotralstat) capsules, for oral use ORLADEYO (berotralstat) oral pellets Initial U.S. Approval: 202020260213