FDA.reportPublic FDA data

trofinetide 200 MG/ML Oral Solution

RxCUI
2632857
RxNorm name
trofinetide 200 MG/ML Oral Solution
Display name
trofinetide 200 MG/ML Oral Solution
Full name
trofinetide 200 MG/ML Oral Solution
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:01

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
DaybueTROFINETIDEAcadia Pharmaceuticals Inc.67e6f2d9-21f6-466f-9def-826c6a4b82572026-09-04Warnings, Adverse reactionsExact identifier
rxcui: 2632857

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
67e6f2d9-21f6-466f-9def-826c6a4b8257trofinetide 200 MG/mL Oral Solution [PSN] · trofinetide 200 MG/ML Oral Solution [SCD]210These highlights do not include all the information needed to use DAYBUE or DAYBUE STIX safely and effectively. See full prescribing information for DAYBUE and DAYBUE STIX. DAYBUE ® (trofinetide) oral solution DAYBUE ® STIX (trofinetide) for oral solution Initial U.S. Approval: 202320260403