nitisinone 5 MG Oral Capsule

RxCUI: 351174
RxNorm name: nitisinone 5 MG Oral Capsule
Display name: nitisinone 5 MG Oral Capsule
Full name: nitisinone 5 MG Oral Capsule
Term type: PSN
Status: DailyMed mapping
Updated: 2026-06-04 23:39:08

RxNav Current And Historical NDCs#

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UNII Substances#

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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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nitisinone	NITISINONE	Par Health USA, LLC	437868f5-1c9e-4b0f-8a03-77df8ac0900d	2026-08-06	Warnings, Adverse reactions	Exact identifier rxcui: 351174
Nitisinone	NITISINONE	Analog Pharma	645c8387-30d5-4a86-a5d8-2f6b5df6d5f0	2025-09-05	Warnings, Adverse reactions	Exact identifier rxcui: 351174
Nitisinone	NITISINONE	Eton Pharmaceuticals, Inc.	dc5e4875-fcd7-408c-88c9-4a715f4384b6	2024-02-02	Warnings, Adverse reactions	Exact identifier rxcui: 351174
Nitisinone	NITISINONE	Bryant Ranch Prepack	8cec0318-9f55-4340-b14b-588635619251	2024-01-10	Warnings, Adverse reactions	Exact identifier rxcui: 351174
Orfadin	NITISINONE	SWEDISH ORPHAN BIOVITRUM AB (PUBL)	5d449b73-d503-4132-b978-d890491975df	2021-11-30	Warnings, Adverse reactions	Exact identifier rxcui: 351174

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 ID	RxNorm mappings	Terms	SPL version	Label	Effective
8cec0318-9f55-4340-b14b-588635619251	nitisinone 5 MG Oral Capsule [PSN] · nitisinone 5 MG Oral Capsule [SCD]	2	102	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: 2002	20240110
5d449b73-d503-4132-b978-d890491975df	nitisinone 5 MG Oral Capsule [PSN] · nitisinone 5 MG Oral Capsule [SCD]	2	14	These 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: 2002	20211130
645c8387-30d5-4a86-a5d8-2f6b5df6d5f0	nitisinone 5 MG Oral Capsule [PSN] · nitisinone 5 MG Oral Capsule [SCD]	2	7	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: 2002	20250905
437868f5-1c9e-4b0f-8a03-77df8ac0900d	nitisinone 5 MG Oral Capsule [PSN] · nitisinone 5 MG Oral Capsule [SCD]	2	7	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: 2002	20250331
dc5e4875-fcd7-408c-88c9-4a715f4384b6	nitisinone 5 MG Oral Capsule [PSN] · nitisinone 5 MG Oral Capsule [SCD]	2	5	HIGHLIGHTS 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: 2002	20240202