Nitisinone

Product NDC: 0254-3021
Requested package NDC: 0254-3021-02
11-digit product format: 002543021
Labeler code: 0254
Product ID: 0254-3021_8d22274c-76b2-4da0-85e0-c0fc61c7db0e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitisinone
Dosage form: CAPSULE
Route: ORAL
Labeler: Endo USA, Inc.
Application: ANDA211041
Marketing category: ANDA
Marketing start: 2019-10-04
Substance: NITISINONE
Active strength: 5 mg/1
Pharmacologic classes: 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2E1 Inducers [MoA], Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA], Organic Anion Transporter 1 Inhibitors [MoA], Organic Anion Transporter 3 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A211041-001	NITISINONE	NITISINONE	2MG	CAPSULE / ORAL	AB	2019-08-26
A211041-002	NITISINONE	NITISINONE	5MG	CAPSULE / ORAL	AB	2019-08-26
A211041-003	NITISINONE	NITISINONE	10MG	CAPSULE / ORAL	AB	2019-08-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A211041-001	AB
A211041-002	AB
A211041-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211041-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2019-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211041-002	NITISINONE	5MG	CAPSULE / ORAL	AB	2019-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211041-003	NITISINONE	10MG	CAPSULE / ORAL	AB	2019-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211041-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2019-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211041-002	NITISINONE	5MG	CAPSULE / ORAL	AB	2019-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211041-003	NITISINONE	10MG	CAPSULE / ORAL	AB	2019-08-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211041-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2019-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211041-002	NITISINONE	5MG	CAPSULE / ORAL	AB	2019-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211041-003	NITISINONE	10MG	CAPSULE / ORAL	AB	2019-08-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211041-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2019-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211041-002	NITISINONE	5MG	CAPSULE / ORAL	AB	2019-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211041-003	NITISINONE	10MG	CAPSULE / ORAL	AB	2019-08-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211041-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2019-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211041-002	NITISINONE	5MG	CAPSULE / ORAL	AB	2019-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211041-003	NITISINONE	10MG	CAPSULE / ORAL	AB	2019-08-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211041-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2019-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211041-002	NITISINONE	5MG	CAPSULE / ORAL	AB	2019-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211041-003	NITISINONE	10MG	CAPSULE / ORAL	AB	2019-08-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211041-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2019-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211041-002	NITISINONE	5MG	CAPSULE / ORAL	AB	2019-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211041-003	NITISINONE	10MG	CAPSULE / ORAL	AB	2019-08-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211041-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2019-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211041-002	NITISINONE	5MG	CAPSULE / ORAL	AB	2019-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211041-003	NITISINONE	10MG	CAPSULE / ORAL	AB	2019-08-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211041-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2019-08-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211041-002	NITISINONE	5MG	CAPSULE / ORAL	AB	2019-08-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211041-003	NITISINONE	10MG	CAPSULE / ORAL	AB	2019-08-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211041-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2019-08-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211041-002	NITISINONE	5MG	CAPSULE / ORAL	AB	2019-08-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211041-003	NITISINONE	10MG	CAPSULE / ORAL	AB	2019-08-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211041-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2019-08-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211041-002	NITISINONE	5MG	CAPSULE / ORAL	AB	2019-08-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211041-003	NITISINONE	10MG	CAPSULE / ORAL	AB	2019-08-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211041-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2019-08-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211041-002	NITISINONE	5MG	CAPSULE / ORAL	AB	2019-08-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211041-003	NITISINONE	10MG	CAPSULE / ORAL	AB	2019-08-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211041-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2019-08-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211041-002	NITISINONE	5MG	CAPSULE / ORAL	AB	2019-08-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211041-003	NITISINONE	10MG	CAPSULE / ORAL	AB	2019-08-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211041-001	NITISINONE	2MG	CAPSULE / ORAL	AB	2019-08-26	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211041-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211041-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211041-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211041-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211041-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211041-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211041-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211041-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211041-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211041-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211041-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211041-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211041-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211041-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211041-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211041-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211041-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211041-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211041-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211041-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211041-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211041-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211041-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211041-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211041-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211041-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211041-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211041-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211041-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211041-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211041-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211041-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211041-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211041-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211041-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211041-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211041-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211041-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211041-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211041-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Nitisinone
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NITISINONE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
K5BN214699	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
437868f5-1c9e-4b0f-8a03-77df8ac0900d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
30289e20-d00d-4455-8aae-af8add8f10ee	Product name	4	20240529
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
5b3e65b0-2e25-4346-b6a5-74172e0cd130	Product name	1	20170824
689eee6a-c9bd-41ef-86ac-b494143eb282	Product name	2	20160804
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0254-3021-02	Nitisinone	60 in 1 BOTTLE	CAPSULE	60		7
0254-3021-02	Nitisinone	1 in 1 CARTON	CAPSULE	1		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0254-3021-02	EA - Each	0254-3021	a6a0a734-2443-4edd-9c27-feaefb12c20a	1	2019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0254-3021	NITISINONE CAPSULE [ENDO USA, INC.]	7	Current NDC, Legacy NDC, 2 package rows	20250406_437868f5-1c9e-4b0f-8a03-77df8ac0900d.zip

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 · 4 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 application applno (ANDA): 211041 application number: ANDA211041 ndc (package): 0254-3021-02 ndc (product): 0254-3021 ndc11 (package): 00254302102
Nitisinone	NITISINONE	Bryant Ranch Prepack	c1b3adc8-02fa-4e22-8c05-8f32b586e53f	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211041 application number: ANDA211041
Nitisinone	NITISINONE	Bryant Ranch Prepack	8cec0318-9f55-4340-b14b-588635619251	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211041 application number: ANDA211041
Nitisinone	NITISINONE	Bryant Ranch Prepack	b7c38003-6899-4508-a69a-aef1231de22c	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211041 application number: ANDA211041

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
K5BN214699	NITISINONE	104206-65-7	NITISINONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
351174	nitisinone 5 MG Oral Capsule	PSN	8cec0318-9f55-4340-b14b-588635619251	102
351174	nitisinone 5 MG Oral Capsule	SCD	8cec0318-9f55-4340-b14b-588635619251	102
351175	nitisinone 10 MG Oral Capsule	PSN	437868f5-1c9e-4b0f-8a03-77df8ac0900d	7
351173	nitisinone 2 MG Oral Capsule	PSN	437868f5-1c9e-4b0f-8a03-77df8ac0900d	7
351174	nitisinone 5 MG Oral Capsule	PSN	437868f5-1c9e-4b0f-8a03-77df8ac0900d	7
351175	nitisinone 10 MG Oral Capsule	SCD	437868f5-1c9e-4b0f-8a03-77df8ac0900d	7
351173	nitisinone 2 MG Oral Capsule	SCD	437868f5-1c9e-4b0f-8a03-77df8ac0900d	7
351174	nitisinone 5 MG Oral Capsule	SCD	437868f5-1c9e-4b0f-8a03-77df8ac0900d	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0254-3021-02	00254302102	1 BOTTLE in 1 CARTON (0254-3021-02) / 60 CAPSULE in 1 BOTTLE	1 bottle	2019-10-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nitisinone	Par Health USA, LLC	2026-08-06	Human Prescription Drug Label	8
Nitisinone	Bryant Ranch Prepack	2024-01-10	HUMAN PRESCRIPTION DRUG LABEL	102