JOURNAVX

Product NDC: 51167-548
11-digit product format: 511670548
Labeler code: 51167
Product ID: 51167-548_6af8a930-2a29-428c-96da-94045a1f7d4e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Suzetrigine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Vertex Pharmaceuticals Incorporated
Application: NDA219209
Marketing category: NDA
Marketing start: 2025-01-30
Substance: SUZETRIGINE
Active strength: 50 mg/1
Pharmacologic classes: Cytochrome P450 3A Inducers [MoA], Sodium Channel Antagonists [MoA], Sodium Channel Blocker [EPC]
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 43.

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
N219209-001	JOURNAVX	SUZETRIGINE	50MG	TABLET / ORAL		RLD, RS	2025-01-30

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
N219209-001	11834441	2040-12-04	U-4125	Drug substance, Drug product	2025-02-20

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219209-001	NCE	2030-01-30

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
2026-09-14 22:38:34	2026-08	N219209-001	JOURNAVX	50MG	TABLET / ORAL	RLD, RS	2025-01-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219209-001	JOURNAVX	50MG	TABLET / ORAL	RLD, RS	2025-01-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219209-001	JOURNAVX	50MG	TABLET / ORAL	RLD, RS	2025-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219209-001	JOURNAVX	50MG	TABLET / ORAL	RLD, RS	2025-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219209-001	JOURNAVX	50MG	TABLET / ORAL	RLD, RS	2025-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219209-001	JOURNAVX	50MG	TABLET / ORAL	RLD, RS	2025-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N219209-001	JOURNAVX	50MG	TABLET / ORAL	RLD, RS	2025-01-30	`b8a1b40f171c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219209-001	JOURNAVX	50MG	TABLET / ORAL	RLD, RS	2025-01-30	`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
2026-09-14 22:38:34	2026-08	N219209-001	11834441	2040-12-04	U-4125	Drug substance, Drug product	2025-02-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219209-001	11834441	2040-12-04	U-4125	Drug substance, Drug product	2025-02-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219209-001	11834441	2040-12-04	U-4125	Drug substance, Drug product	2025-02-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219209-001	11834441	2040-12-04	U-4125	Drug substance, Drug product	2025-02-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219209-001	11834441	2040-12-04	U-4125	Drug substance, Drug product	2025-02-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219209-001	11834441	2040-12-04	U-4125	Drug substance, Drug product	2025-02-20	`fd3edfee7708…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219209-001	11834441	2040-12-04	U-4125	Drug substance, Drug product	2025-02-20	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N219209-001	NCE	2030-01-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219209-001	NCE	2030-01-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219209-001	NCE	2030-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219209-001	NCE	2030-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219209-001	NCE	2030-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219209-001	NCE	2030-01-30	`fd3edfee7708…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219209-001	NCE	2030-01-30	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SUZETRIGINE	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
LOG73M21H5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2704833	Internal RxNorm lookup
2704839	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
f0976da4-1d20-4517-945c-b60ed2f41c12	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
934b51b5-5c74-4f29-87c4-3a4731ac1b22	Product name	1	20251117
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51167-548-05	JOURNAVX	5 in 1 BLISTER PACK	TABLET, FILM COATED	5	9
51167-548-25	JOURNAVX	5 in 1 CARTON	TABLET, FILM COATED	5	9
51167-548-30	JOURNAVX	30 in 1 BOTTLE	TABLET, FILM COATED	30	9
51167-548-31	JOURNAVX	100 in 1 BOTTLE	TABLET, FILM COATED	100	9
51167-548-34	JOURNAVX	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	9
51167-548-34	JOURNAVX	10 in 1 CARTON	TABLET, FILM COATED	10	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51167-548-30	EA - Each	51167-548	e151a7ca-a078-4dd2-8e2d-91364d3da6c0	1	2025-03-04
51167-548-34	EA - Each	51167-548	d4e7a6f0-44fc-442d-af93-05078e5ca00c	1	2025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51167-548	JOURNAVX (SUZETRIGINE) TABLET, FILM COATED [VERTEX PHARMACEUTICALS INCORPORATED]	3	Current NDC, 6 package rows	20250210_f0976da4-1d20-4517-945c-b60ed2f41c12.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
JOURNAVX	SUZETRIGINE	Sportpharm LLC	d229cf71-96ec-4206-960b-d56fafc250ac	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 219209 application number: NDA219209
JOURNAVX	SUZETRIGINE	Vertex Pharmaceuticals Incorporated	f0976da4-1d20-4517-945c-b60ed2f41c12	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 219209 application number: NDA219209 ndc (product): 51167-548

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2704839	JOURNAVX 50 MG Oral Tablet	PSN	f0976da4-1d20-4517-945c-b60ed2f41c12	9
2704833	suzetrigine 50 MG Oral Tablet	PSN	f0976da4-1d20-4517-945c-b60ed2f41c12	9
2704839	suzetrigine 50 MG Oral Tablet [Journavx]	SBD	f0976da4-1d20-4517-945c-b60ed2f41c12	9
2704833	suzetrigine 50 MG Oral Tablet	SCD	f0976da4-1d20-4517-945c-b60ed2f41c12	9
2704839	Journavx 50 MG Oral Tablet	SY	f0976da4-1d20-4517-945c-b60ed2f41c12	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
51167-548-05	51167054805	5 in 1 BLISTER PACK					Historical
51167-548-25	51167054825	5 BLISTER PACK in 1 CARTON (51167-548-25) / 5 TABLET, FILM COATED in 1 BLISTER PACK (51167-548-05)	5 blister pack	2025-01-30	Yes	No	Current
51167-548-30	51167054830	30 TABLET, FILM COATED in 1 BOTTLE (51167-548-30)		2025-01-30	No	No	Current
51167-548-31	51167054831	100 TABLET, FILM COATED in 1 BOTTLE (51167-548-31)		2025-01-30	No	No	Current
51167-548-34	51167054834	10 BLISTER PACK in 1 CARTON (51167-548-34) / 10 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2025-01-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
JOURNAVX	Sportpharm LLC	2026-07-21	HUMAN PRESCRIPTION DRUG LABEL	2
JOURNAVX	Vertex Pharmaceuticals Incorporated	2026-04-13	HUMAN PRESCRIPTION DRUG LABEL	9