Sephience

Product NDC: 52856-301
11-digit product format: 528560301
Labeler code: 52856
Product ID: 52856-301_15baff9a-9d66-4546-b209-7a570a2f16c5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sepiapterin
Dosage form: POWDER
Route: ORAL
Labeler: PTC Therapeutics Inc.
Application: NDA219666
Marketing category: NDA
Marketing start: 2025-07-28
Substance: SEPIAPTERIN
Active strength: 1000 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N219666-001	SEPHIENCE	SEPIAPTERIN	250MG/PACKET	POWDER / ORAL		RLD	2025-07-28
N219666-002	SEPHIENCE	SEPIAPTERIN	1GM/PACKET	POWDER / ORAL		RLD, RS	2025-07-28

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N219666-001	11072614	2038-04-16	U-4251	Drug substance	2025-08-26
N219666-001	11752154	2038-09-04	U-4251	Drug product	2025-08-26
N219666-001	12213982	2038-09-04	U-4251		2025-08-26
N219666-001	12257252	2042-03-06	U-4250		2025-08-26
N219666-002	11072614	2038-04-16	U-4251	Drug substance	2025-08-26
N219666-002	11752154	2038-09-04	U-4251	Drug product	2025-08-26
N219666-002	12213982	2038-09-04	U-4251		2025-08-26
N219666-002	12257252	2042-03-06	U-4250		2025-08-26

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219666-001	NCE	2030-07-28
N219666-001	ODE-542	2032-07-28
N219666-002	NCE	2030-07-28
N219666-002	ODE-542	2032-07-28

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N219666-001	SEPHIENCE	250MG/PACKET	POWDER / ORAL	RLD	2025-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219666-002	SEPHIENCE	1GM/PACKET	POWDER / ORAL	RLD, RS	2025-07-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219666-001	SEPHIENCE	250MG/PACKET	POWDER / ORAL	RLD	2025-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219666-002	SEPHIENCE	1GM/PACKET	POWDER / ORAL	RLD, RS	2025-07-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219666-001	SEPHIENCE	250MG/PACKET	POWDER / ORAL	RLD	2025-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219666-002	SEPHIENCE	1GM/PACKET	POWDER / ORAL	RLD, RS	2025-07-28	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219666-001	SEPHIENCE	250MG/PACKET	POWDER / ORAL	RLD	2025-07-28	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219666-002	SEPHIENCE	1GM/PACKET	POWDER / ORAL	RLD, RS	2025-07-28	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N219666-001	11072614	2038-04-16	U-4251	Drug substance	2025-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219666-001	11752154	2038-09-04	U-4251	Drug product	2025-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219666-001	12213982	2038-09-04	U-4251		2025-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219666-001	12257252	2042-03-06	U-4250		2025-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219666-002	11072614	2038-04-16	U-4251	Drug substance	2025-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219666-002	11752154	2038-09-04	U-4251	Drug product	2025-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219666-002	12213982	2038-09-04	U-4251		2025-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219666-002	12257252	2042-03-06	U-4250		2025-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219666-001	11072614	2038-04-16	U-4251	Drug substance	2025-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219666-001	11752154	2038-09-04	U-4251	Drug product	2025-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219666-001	12213982	2038-09-04	U-4251		2025-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219666-001	12257252	2042-03-06	U-4250		2025-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219666-002	11072614	2038-04-16	U-4251	Drug substance	2025-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219666-002	11752154	2038-09-04	U-4251	Drug product	2025-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219666-002	12213982	2038-09-04	U-4251		2025-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219666-002	12257252	2042-03-06	U-4250		2025-08-26	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219666-001	11072614	2038-04-16	U-4251	Drug substance	2025-08-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219666-001	11752154	2038-09-04	U-4251	Drug product	2025-08-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219666-001	12213982	2038-09-04	U-4251		2025-08-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219666-001	12257252	2042-03-06	U-4250		2025-08-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219666-002	11072614	2038-04-16	U-4251	Drug substance	2025-08-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219666-002	11752154	2038-09-04	U-4251	Drug product	2025-08-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219666-002	12213982	2038-09-04	U-4251		2025-08-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219666-002	12257252	2042-03-06	U-4250		2025-08-26	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N219666-001	NCE	2030-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219666-002	NCE	2030-07-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219666-001	NCE	2030-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219666-002	NCE	2030-07-28	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219666-001	NCE	2030-07-28	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219666-001	ODE-542	2032-07-28	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219666-002	NCE	2030-07-28	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219666-002	ODE-542	2032-07-28	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SEPIAPTERIN	1000 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
CJQ26KO7HP	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2723061	Internal RxNorm lookup
2723067	Internal RxNorm lookup
2723069	Internal RxNorm lookup
2723071	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
32ac719c-49f0-4105-9c46-18c19583a5c2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
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
52856-301-01	Sephience	1 in 1 PACKET	POWDER	1		6
52856-301-03	Sephience	30 in 1 CARTON	POWDER	30		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52856-301-01	EA - Each	52856-301	0a107ed2-1cde-4e6a-bfc7-f993d7765e47	1	2025-09-12
52856-301-03	EA - Each	52856-301	4eff6e5a-9d46-421d-8907-727b5ae705ff	1	2025-09-12

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sephience	SEPIAPTERIN	PTC Therapeutics Inc.	32ac719c-49f0-4105-9c46-18c19583a5c2	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 219666 application number: NDA219666 ndc (product): 52856-301
Sephience	SEPIAPTERIN	allphamed Pharbil Arzneimittel GmbH	9fabfee2-9488-4d03-b203-8fa50f9a7f55	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 219666 application number: NDA219666

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
CJQ26KO7HP	SEPIAPTERIN	17094-01-8	SEPIAPTERIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2723067	Sephience 1000 MG Oral Powder	PSN	32ac719c-49f0-4105-9c46-18c19583a5c2	6
2723071	Sephience 250 MG Oral Powder	PSN	32ac719c-49f0-4105-9c46-18c19583a5c2	6
2723061	sepiapterin 1000 MG Oral Powder	PSN	32ac719c-49f0-4105-9c46-18c19583a5c2	6
2723069	sepiapterin 250 MG Oral Powder	PSN	32ac719c-49f0-4105-9c46-18c19583a5c2	6
2723067	sepiapterin 1000 MG Oral Powder [Sephience]	SBD	32ac719c-49f0-4105-9c46-18c19583a5c2	6
2723071	sepiapterin 250 MG Oral Powder [Sephience]	SBD	32ac719c-49f0-4105-9c46-18c19583a5c2	6
2723061	sepiapterin 1000 MG Oral Powder	SCD	32ac719c-49f0-4105-9c46-18c19583a5c2	6
2723069	sepiapterin 250 MG Oral Powder	SCD	32ac719c-49f0-4105-9c46-18c19583a5c2	6
2723067	Sephience 1000 MG Oral Powder	SY	32ac719c-49f0-4105-9c46-18c19583a5c2	6
2723071	Sephience 250 MG Oral Powder	SY	32ac719c-49f0-4105-9c46-18c19583a5c2	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
52856-301-01	52856030101	1 in 1 PACKET					Historical
52856-301-03	52856030103	30 PACKET in 1 CARTON (52856-301-03) / 1 POWDER in 1 PACKET (52856-301-01)	30 packet	2025-07-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sephience - PTC Therapeutics Inc.	PTC Therapeutics Inc.	2026-04-24	HUMAN PRESCRIPTION DRUG LABEL	6