ORFADIN

Product NDC: 66658-204
11-digit product format: 666580204
Labeler code: 66658
Product ID: 66658-204_463bdca4-b840-6f9f-e063-6294a90ab3b5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nitisinone
Dosage form: SUSPENSION
Route: ORAL
Labeler: Swedish Orphan Biovitrum AB (publ)
Application: NDA206356
Marketing category: NDA
Marketing start: 2016-06-01
Substance: NITISINONE
Active strength: 4 mg/mL
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 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N206356-001	ORFADIN	NITISINONE	4MG/ML	SUSPENSION / ORAL		RLD, RS	2016-04-22

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N206356-001	ORFADIN	4MG/ML	SUSPENSION / ORAL	RLD, RS	2016-04-22	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N206356-001	9301932	2033-02-28	U-1836	Drug product	2016-05-04	`e64feba35796…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N206356-001	D-169	2020-09-01	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N206356-001	D-169	2020-09-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206356-001	D-169	2020-09-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206356-001	D-169	2020-09-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206356-001	D-169	2020-09-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N206356-001	D-169	2020-09-01	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: ORFADIN
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NITISINONE	4 mg/mL

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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1790310	Internal RxNorm lookup
1790317	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
00307f42-748d-4227-8c6f-ed5f0a89ae0a	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
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
5b3e65b0-2e25-4346-b6a5-74172e0cd130	Product name	1	20170824
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
689eee6a-c9bd-41ef-86ac-b494143eb282	Product name	2	20160804

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66658-204-90	2021-07-28	C162847	48780-1	c7ccaba7-161a-fd44-e053-dadaa90aa01b	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
66658-204-90	2021-07-23	C162847	48780-1	c7ccaba7-161a-fd44-e053-dadaa90aa01b	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66658-204-90	ORFADIN	90 mL in 1 BOTTLE, GLASS	SUSPENSION	90		12
66658-204-90	ORFADIN	1 in 1 CARTON	SUSPENSION	1		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66658-204-90	ML - Milliliter	66658-204	dc1f2196-bfdb-4e71-b745-67474384612d	1	2016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66658-204	ORFADIN (NITISINONE) SUSPENSION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)]	11	Current NDC, Legacy NDC, 2 package rows	20220706_00307f42-748d-4227-8c6f-ed5f0a89ae0a.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ORFADIN	NITISINONE	Swedish Orphan Biovitrum AB (publ)	00307f42-748d-4227-8c6f-ed5f0a89ae0a	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 206356 application number: NDA206356 ndc (product): 66658-204

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
1790310	nitisinone 4 MG in 1 mL Oral Suspension	PSN	00307f42-748d-4227-8c6f-ed5f0a89ae0a	12
1790317	Orfadin 4 MG in 1 mL Oral Suspension	PSN	00307f42-748d-4227-8c6f-ed5f0a89ae0a	12
1790317	nitisinone 4 MG/ML Oral Suspension [Orfadin]	SBD	00307f42-748d-4227-8c6f-ed5f0a89ae0a	12
1790310	nitisinone 4 MG/ML Oral Suspension	SCD	00307f42-748d-4227-8c6f-ed5f0a89ae0a	12
1790310	nitisinone 4 MG per 1 ML Oral Suspension	SY	00307f42-748d-4227-8c6f-ed5f0a89ae0a	12
1790317	Orfadin 4 MG per 1 ML Oral Suspension	SY	00307f42-748d-4227-8c6f-ed5f0a89ae0a	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
66658-204-90	66658020490	1 BOTTLE, GLASS in 1 CARTON (66658-204-90) / 90 mL in 1 BOTTLE, GLASS	2016-06-01	0000-00-00	No	No	Current