Home NDC 85766-243-99 JOURNAVX
Product NDC 85766-243
Requested package NDC 85766-243-99
11-digit product format 857660243
Labeler code 85766
Product ID 85766-243_57223f5a-370d-d9d6-e063-6394a90ab906
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Suzetrigine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sportpharm LLC
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 Product TE source text 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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85766-243-99 85766024399 10 BLISTER PACK in 1 CARTON (85766-243-99) / 10 TABLET, FILM COATED in 1 BLISTER PACK 10 blister pack 2026-07-13 No No Current