FDA.reportPublic FDA data

Sephience 250 MG Oral Powder

RxCUI
2723071
RxNorm name
Sephience 250 MG Oral Powder
Display name
Sephience 250 MG Oral Powder
Full name
Sephience 250 MG Oral Powder
Term type
SY
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SephienceSEPIAPTERINPTC Therapeutics Inc.32ac719c-49f0-4105-9c46-18c19583a5c22026-04-24Warnings, Adverse reactionsExact identifier
rxcui: 2723071
SephienceSEPIAPTERINallphamed Pharbil Arzneimittel GmbH9fabfee2-9488-4d03-b203-8fa50f9a7f552025-10-02Warnings, Adverse reactionsExact identifier
rxcui: 2723071

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 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
32ac719c-49f0-4105-9c46-18c19583a5c2Sephience 250 MG Oral Powder [PSN] · sepiapterin 250 MG Oral Powder [Sephience] [SBD] · Sephience 250 MG Oral Powder [SY]36These highlights do not include all the information needed to use SEPHIENCE safely and effectively. See full prescribing information for SEPHIENCE. SEPHIENCE (sepiapterin) oral powder Initial U.S. Approval: 202520260424
9fabfee2-9488-4d03-b203-8fa50f9a7f55Sephience 250 MG Oral Powder [PSN] · sepiapterin 250 MG Oral Powder [Sephience] [SBD] · Sephience 250 MG Oral Powder [SY]31These highlights do not include all the information needed to use SEPHIENCE safely and effectively. See full prescribing information for SEPHIENCE. SEPHIENCE (sepiapterin) oral powder Initial U.S. Approval: 202520251002