FDA.reportPublic FDA data

nitisinone 2 MG Oral Capsule

RxCUI
351173
RxNorm name
nitisinone 2 MG Oral Capsule
Display name
nitisinone 2 MG Oral Capsule
Full name
nitisinone 2 MG Oral Capsule
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:17

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NitisinoneNITISINONEPar Health USA, LLC437868f5-1c9e-4b0f-8a03-77df8ac0900d2026-08-06Warnings, Adverse reactionsExact identifier
rxcui: 351173
NitisinoneNITISINONEAnalog Pharma645c8387-30d5-4a86-a5d8-2f6b5df6d5f02025-09-05Warnings, Adverse reactionsExact identifier
rxcui: 351173
NitisinoneNITISINONEEton Pharmaceuticals, Inc.dc5e4875-fcd7-408c-88c9-4a715f4384b62024-02-02Warnings, Adverse reactionsExact identifier
rxcui: 351173
NitisinoneNITISINONEBryant Ranch Prepackb7c38003-6899-4508-a69a-aef1231de22c2024-01-10Warnings, Adverse reactionsExact identifier
rxcui: 351173
OrfadinNITISINONESWEDISH ORPHAN BIOVITRUM AB (PUBL)5d449b73-d503-4132-b978-d890491975df2021-11-30Warnings, Adverse reactionsExact identifier
rxcui: 351173

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 5 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
b7c38003-6899-4508-a69a-aef1231de22cnitisinone 2 MG Oral Capsule [PSN] · nitisinone 2 MG Oral Capsule [SCD]2104These highlights do not include all the information needed to use NITISINONE CAPSULES safely and effectively. See full prescribing information for NITISINONE CAPSULES. NITISINONE capsules, for oral use. Initial U.S. Approval: 200220240110
5d449b73-d503-4132-b978-d890491975dfnitisinone 2 MG Oral Capsule [PSN] · nitisinone 2 MG Oral Capsule [SCD]214These 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
645c8387-30d5-4a86-a5d8-2f6b5df6d5f0nitisinone 2 MG Oral Capsule [PSN] · nitisinone 2 MG Oral Capsule [SCD]27These highlights do not include all the information needed to use NITISINONE CAPSULES safely and effectively. See full prescribing information for NITISINONE CAPSULES. NITISINONE capsules, for oral use Initial U.S. Approval: 200220250905
437868f5-1c9e-4b0f-8a03-77df8ac0900dnitisinone 2 MG Oral Capsule [PSN] · nitisinone 2 MG Oral Capsule [SCD]27These highlights do not include all the information needed to use NITISINONE CAPSULES safely and effectively. See full prescribing information for NITISINONE CAPSULES. NITISINONE capsules, for oral use Initial U.S. Approval: 200220250331
dc5e4875-fcd7-408c-88c9-4a715f4384b6nitisinone 2 MG Oral Capsule [PSN] · nitisinone 2 MG Oral Capsule [SCD]25HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NITISINONE CAPSULES safely and effectively. See full prescribing information for NITISINONE CAPSULES. NITISINONE Capsules, for oral use Initial U.S. Approval: 200220240202