Home NDC 76431-310 FILSUVEZ
Product NDC 76431-310
11-digit product format 764310310
Labeler code 76431
Product ID 76431-310_59bc2507-59e9-48c0-8c87-f65bb0f32258
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name birch triterpenes
Dosage form GEL
Route TOPICAL
Labeler Amryt Pharmaceuticals DAC
Application NDA215064
Marketing category NDA
Marketing start 2024-02-22
Marketing end 2028-06-01
Substance BIRCH TRITERPENES
Active strength 100 mg/g
NDC exclude flag No
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N215064-001 FILSUVEZ BIRCH TRITERPENES 10% GEL / TOPICAL RLD, RS 2023-12-18
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215064-001 8828444 2027-06-21 Drug product 2024-02-16 N215064-001 9352041 2030-11-24 U-3811 2024-02-16 N215064-001 9827214 2030-11-24 U-3811 2024-02-16 N215064-001 11083733 2039-01-04 Drug product 2024-02-16 N215064-001 11266660 2039-01-04 U-3811 2024-02-16 N215064-001 12268695 2039-01-04 U-3811 2025-05-02
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N215064-001 NCE 2028-12-18 N215064-001 ODE-460 2030-12-18
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 2026-02-19 14:30 UTC 2026-02 N215064-001 FILSUVEZ 10% GEL / TOPICAL RLD, RS 2023-12-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215064-001 FILSUVEZ 10% GEL / TOPICAL RLD, RS 2023-12-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215064-001 FILSUVEZ 10% GEL / TOPICAL RLD, RS 2023-12-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215064-001 FILSUVEZ 10% GEL / TOPICAL RLD, RS 2023-12-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215064-001 FILSUVEZ 10% GEL / TOPICAL RLD, RS 2023-12-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215064-001 FILSUVEZ 10% GEL / TOPICAL RLD, RS 2023-12-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215064-001 FILSUVEZ 10% GEL / TOPICAL RLD, RS 2023-12-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215064-001 FILSUVEZ 10% GEL / TOPICAL RLD, RS 2023-12-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215064-001 FILSUVEZ 10% GEL / TOPICAL RLD, RS 2023-12-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215064-001 FILSUVEZ 10% GEL / TOPICAL RLD, RS 2023-12-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215064-001 FILSUVEZ 10% GEL / TOPICAL RLD, RS 2023-12-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215064-001 FILSUVEZ 10% GEL / TOPICAL RLD, RS 2023-12-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215064-001 FILSUVEZ 10% GEL / TOPICAL RLD, RS 2023-12-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215064-001 FILSUVEZ 10% GEL / TOPICAL RLD, RS 2023-12-18 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215064-001 FILSUVEZ 10% GEL / TOPICAL RLD, RS 2023-12-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215064-001 FILSUVEZ 10% GEL / TOPICAL RLD, RS 2023-12-18 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215064-001 FILSUVEZ 10% GEL / TOPICAL RLD, RS 2023-12-18 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 84 observed states.
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 N215064-001 8828444 2026-06-21 Drug product 2024-02-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215064-001 9352041 2030-11-24 U-3811 2024-02-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215064-001 9827214 2030-11-24 U-3811 2024-02-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215064-001 11083733 2039-01-04 Drug product 2024-02-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215064-001 11266660 2039-01-04 U-3811 2024-02-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215064-001 12268695 2039-01-04 U-3811 2025-05-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215064-001 8828444 2026-06-21 Drug product 2024-02-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215064-001 9352041 2030-11-24 U-3811 2024-02-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215064-001 9827214 2030-11-24 U-3811 2024-02-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215064-001 11083733 2039-01-04 Drug product 2024-02-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215064-001 11266660 2039-01-04 U-3811 2024-02-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215064-001 12268695 2039-01-04 U-3811 2025-05-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215064-001 8828444 2026-06-21 Drug product 2024-02-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215064-001 9352041 2030-11-24 U-3811 2024-02-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215064-001 9827214 2030-11-24 U-3811 2024-02-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215064-001 11083733 2039-01-04 Drug product 2024-02-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215064-001 11266660 2039-01-04 U-3811 2024-02-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215064-001 12268695 2039-01-04 U-3811 2025-05-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215064-001 8828444 2025-06-21 Drug product 2024-02-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215064-001 9352041 2030-11-24 U-3811 2024-02-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215064-001 9827214 2030-11-24 U-3811 2024-02-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215064-001 11083733 2039-01-04 Drug product 2024-02-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215064-001 11266660 2039-01-04 U-3811 2024-02-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215064-001 8828444 2025-06-21 Drug product 2024-02-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215064-001 9352041 2030-11-24 U-3811 2024-02-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215064-001 9827214 2030-11-24 U-3811 2024-02-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215064-001 11083733 2039-01-04 Drug product 2024-02-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215064-001 11266660 2039-01-04 U-3811 2024-02-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215064-001 8828444 2025-06-21 Drug product 2024-02-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215064-001 9352041 2030-11-24 U-3811 2024-02-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215064-001 9827214 2030-11-24 U-3811 2024-02-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215064-001 11083733 2039-01-04 Drug product 2024-02-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215064-001 11266660 2039-01-04 U-3811 2024-02-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215064-001 8828444 2025-06-21 Drug product 2024-02-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215064-001 9352041 2030-11-24 U-3811 2024-02-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215064-001 9827214 2030-11-24 U-3811 2024-02-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215064-001 11083733 2039-01-04 Drug product 2024-02-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215064-001 11266660 2039-01-04 U-3811 2024-02-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215064-001 8828444 2025-06-21 Drug product 2024-02-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215064-001 9352041 2030-11-24 U-3811 2024-02-16 5bbf6a4d5a75…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base FILSUVEZ Active Ingredients# Ingredient, Strength table Ingredient Strength BIRCH TRITERPENES 100 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination BX09B0RQR0 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2675587 Internal RxNorm lookup 2675592 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76431-310-01 FILSUVEZ 1 in 1 CARTON GEL 1 9 76431-310-01 FILSUVEZ 23.4 g in 1 TUBE GEL 23.4 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76431-310 FILSUVEZ (BIRCH TRITERPENES) GEL [AMRYT PHARMACEUTICALS DAC] 8 Current NDC, 2 package rows 20240224_da793f2d-0a3d-4792-8c22-982f9f8cdd97.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 76431-310-01 76431031001 1 TUBE in 1 CARTON (76431-310-01) / 23.4 g in 1 TUBE 1 tube 2024-02-22 2028-06-01 No No Historical