FDA.reportPublic FDA data

Orfadin 10 MG Oral Capsule

RxCUI
352121
RxNorm name
Orfadin 10 MG Oral Capsule
Display name
Orfadin 10 MG Oral Capsule
Full name
Orfadin 10 MG Oral Capsule
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:00

RxNav Current And Historical NDCs#

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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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OrfadinNITISINONESWEDISH ORPHAN BIOVITRUM AB (PUBL)5d449b73-d503-4132-b978-d890491975df2021-11-30Warnings, Adverse reactionsExact identifier
rxcui: 352121

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
5d449b73-d503-4132-b978-d890491975dfOrfadin 10 MG Oral Capsule [PSN] · nitisinone 10 MG Oral Capsule [Orfadin] [SBD] · Orfadin 10 MG Oral Capsule [SY]314These highlights do not include all the information needed to use ORFADIN safely and effectively. See full prescribing information for ORFADIN. ORFADIN ® (nitisinone) capsules, for oral use ORFADIN ® (nitisinone) oral suspension Initial U.S. Approval: 200220211130