FDA.reportPublic FDA data

Orfadin 5 MG Oral Capsule

RxCUI
352120
RxNorm name
Orfadin 5 MG Oral Capsule
Display name
Orfadin 5 MG Oral Capsule
Full name
Orfadin 5 MG Oral Capsule
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:00

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
OrfadinNITISINONESWEDISH ORPHAN BIOVITRUM AB (PUBL)5d449b73-d503-4132-b978-d890491975df2021-11-30Warnings, Adverse reactionsExact identifier
rxcui: 352120

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 5 MG Oral Capsule [PSN] · nitisinone 5 MG Oral Capsule [Orfadin] [SBD] · Orfadin 5 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