NITISINONE - Food and Drug Administration

Manufacturer: Food and Drug Administration
Effective date: 2024-05-29
Label type: Indexing - product concept
Version: 4
Source: full-release
Hydrated at: 2026-06-05 00:23:49

Label at a glance#

ProductNITISINONE

Active ingredientNITISINONE

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

NITISINONE

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
NITISINONE	K5BN214699	ACTIB
NITISINONE	K5BN214699	ACTIB
NITISINONE	K5BN214699	ACTIB
NITISINONE	K5BN214699	ACTIB

Source Document#

Source XML

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 · 10 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	Name fallback brand name: Nitisinone generic name: NITISINONE
NITYR	NITISINONE	Cycle Pharmaceuticals Ltd.	00fd1905-27e4-420e-8dc5-a69e4ddc1526	2025-12-22	Warnings, Adverse reactions	Name fallback generic name: NITISINONE
ORFADIN	NITISINONE	Swedish Orphan Biovitrum AB (publ)	00307f42-748d-4227-8c6f-ed5f0a89ae0a	2025-12-18	Warnings, Adverse reactions	Name fallback generic name: NITISINONE
Nitisinone	NITISINONE	Analog Pharma	645c8387-30d5-4a86-a5d8-2f6b5df6d5f0	2025-09-05	Warnings, Adverse reactions	Name fallback brand name: Nitisinone generic name: NITISINONE
HARLIKU	NITISINONE	Cycle Pharmaceuticals Ltd.	7cf67e24-d46b-4376-bbd0-0b973c406d0d	2025-06-02	Warnings, Adverse reactions	Name fallback generic name: NITISINONE
Nitisinone	NITISINONE	Eton Pharmaceuticals, Inc.	dc5e4875-fcd7-408c-88c9-4a715f4384b6	2024-02-02	Warnings, Adverse reactions	Name fallback brand name: Nitisinone generic name: NITISINONE
Nitisinone	NITISINONE	Bryant Ranch Prepack	c1b3adc8-02fa-4e22-8c05-8f32b586e53f	2024-01-10	Warnings, Adverse reactions	Name fallback brand name: Nitisinone generic name: NITISINONE
Nitisinone	NITISINONE	Bryant Ranch Prepack	8cec0318-9f55-4340-b14b-588635619251	2024-01-10	Warnings, Adverse reactions	Name fallback brand name: Nitisinone generic name: NITISINONE
Nitisinone	NITISINONE	Bryant Ranch Prepack	b7c38003-6899-4508-a69a-aef1231de22c	2024-01-10	Warnings, Adverse reactions	Name fallback brand name: Nitisinone generic name: NITISINONE
Orfadin	NITISINONE	SWEDISH ORPHAN BIOVITRUM AB (PUBL)	5d449b73-d503-4132-b978-d890491975df	2021-11-30	Warnings, Adverse reactions	Name fallback generic name: NITISINONE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.