FDA.reportPublic FDA data

FILSUVEZ

Product NDC
10122-310
11-digit product format
101220310
Labeler code
10122
Product ID
10122-310_0b380ed5-013d-47af-8113-4d708bb92180
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
birch triterpenes
Dosage form
GEL
Route
TOPICAL
Labeler
Chiesi USA, Inc.
Application
NDA215064
Marketing category
NDA
Marketing start
2024-02-22
Substance
BIRCH TRITERPENES
Active strength
100 mg/g
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N215064-001FILSUVEZBIRCH TRITERPENES10%GEL / TOPICALRLD, RS2023-12-18

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N215064-00188284442027-06-21Drug product2024-02-16
N215064-00193520412030-11-24U-38112024-02-16
N215064-00198272142030-11-24U-38112024-02-16
N215064-001110837332039-01-04Drug product2024-02-16
N215064-001112666602039-01-04U-38112024-02-16
N215064-001122686952039-01-04U-38112025-05-02

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N215064-001NCE2028-12-18
N215064-001ODE-4602030-12-18

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N215064-001FILSUVEZ10%GEL / TOPICALRLD, RS2023-12-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N215064-001FILSUVEZ10%GEL / TOPICALRLD, RS2023-12-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215064-001FILSUVEZ10%GEL / TOPICALRLD, RS2023-12-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N215064-001FILSUVEZ10%GEL / TOPICALRLD, RS2023-12-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215064-001FILSUVEZ10%GEL / TOPICALRLD, RS2023-12-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215064-001FILSUVEZ10%GEL / TOPICALRLD, RS2023-12-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215064-001FILSUVEZ10%GEL / TOPICALRLD, RS2023-12-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215064-001FILSUVEZ10%GEL / TOPICALRLD, RS2023-12-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215064-001FILSUVEZ10%GEL / TOPICALRLD, RS2023-12-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215064-001FILSUVEZ10%GEL / TOPICALRLD, RS2023-12-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N215064-001FILSUVEZ10%GEL / TOPICALRLD, RS2023-12-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215064-001FILSUVEZ10%GEL / TOPICALRLD, RS2023-12-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N215064-001FILSUVEZ10%GEL / TOPICALRLD, RS2023-12-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N215064-001FILSUVEZ10%GEL / TOPICALRLD, RS2023-12-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N215064-001FILSUVEZ10%GEL / TOPICALRLD, RS2023-12-188072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N215064-001FILSUVEZ10%GEL / TOPICALRLD, RS2023-12-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N215064-001FILSUVEZ10%GEL / TOPICALRLD, RS2023-12-181c564ffb4f44…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215064-001FILSUVEZ10%GEL / TOPICALRLD, RS2023-12-18a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 3 · 90 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N215064-00188284442027-06-21Drug product2024-02-16caaa826d4ba7…
2026-08-18 06:07:402026-07N215064-00193520412030-11-24U-38112024-02-16caaa826d4ba7…
2026-08-18 06:07:402026-07N215064-00198272142030-11-24U-38112024-02-16caaa826d4ba7…
2026-08-18 06:07:402026-07N215064-001110837332039-01-04Drug product2024-02-16caaa826d4ba7…
2026-08-18 06:07:402026-07N215064-001112666602039-01-04U-38112024-02-16caaa826d4ba7…
2026-08-18 06:07:402026-07N215064-001122686952039-01-04U-38112025-05-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N215064-00188284442026-06-21Drug product2024-02-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215064-00193520412030-11-24U-38112024-02-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215064-00198272142030-11-24U-38112024-02-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215064-001110837332039-01-04Drug product2024-02-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215064-001112666602039-01-04U-38112024-02-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215064-001122686952039-01-04U-38112025-05-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215064-00188284442026-06-21Drug product2024-02-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215064-00193520412030-11-24U-38112024-02-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215064-00198272142030-11-24U-38112024-02-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215064-001110837332039-01-04Drug product2024-02-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215064-001112666602039-01-04U-38112024-02-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215064-001122686952039-01-04U-38112025-05-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08N215064-00188284442026-06-21Drug product2024-02-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215064-00193520412030-11-24U-38112024-02-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215064-00198272142030-11-24U-38112024-02-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215064-001110837332039-01-04Drug product2024-02-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215064-001112666602039-01-04U-38112024-02-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215064-001122686952039-01-04U-38112025-05-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215064-00188284442025-06-21Drug product2024-02-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215064-00193520412030-11-24U-38112024-02-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215064-00198272142030-11-24U-38112024-02-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215064-001110837332039-01-04Drug product2024-02-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215064-001112666602039-01-04U-38112024-02-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215064-00188284442025-06-21Drug product2024-02-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215064-00193520412030-11-24U-38112024-02-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215064-00198272142030-11-24U-38112024-02-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215064-001110837332039-01-04Drug product2024-02-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215064-001112666602039-01-04U-38112024-02-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215064-00188284442025-06-21Drug product2024-02-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215064-00193520412030-11-24U-38112024-02-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215064-00198272142030-11-24U-38112024-02-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215064-001110837332039-01-04Drug product2024-02-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215064-001112666602039-01-04U-38112024-02-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215064-00188284442025-06-21Drug product2024-02-162680178bc6a6…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-18 06:07:402026-07N215064-001NCE2028-12-18caaa826d4ba7…
2026-08-18 06:07:402026-07N215064-001ODE-4602030-12-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N215064-001NCE2028-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N215064-001ODE-4602030-12-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215064-001NCE2028-12-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N215064-001ODE-4602030-12-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N215064-001NCE2028-12-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N215064-001ODE-4602030-12-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215064-001NCE2028-12-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N215064-001ODE-4602030-12-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215064-001NCE2028-12-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N215064-001ODE-4602030-12-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215064-001NCE2028-12-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N215064-001ODE-4602030-12-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215064-001NCE2028-12-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N215064-001ODE-4602030-12-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215064-001NCE2028-12-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N215064-001ODE-4602030-12-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215064-001NCE2028-12-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N215064-001ODE-4602030-12-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N215064-001NCE2028-12-18d06236e962d9…
2024-10-29 15:01 UTC2024-10N215064-001ODE-4602030-12-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215064-001NCE2028-12-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N215064-001ODE-4602030-12-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N215064-001NCE2028-12-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N215064-001ODE-4602030-12-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N215064-001NCE2028-12-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N215064-001ODE-4602030-12-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N215064-001NCE2028-12-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05N215064-001ODE-4602030-12-188072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N215064-001ODE-4602030-12-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N215064-001ODE-4602030-12-181c564ffb4f44…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215064-001NCE2028-12-18a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N215064-001ODE-4602030-12-18a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BIRCH TRITERPENES100 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
BX09B0RQR0Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2675587Internal RxNorm lookup
2675592Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
32ba9194-734c-47d4-84e1-b21e28a85ec5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7a33b18d-631c-4c4b-93de-9cf1faef5f73Product name120250103

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10122-310-01FILSUVEZ23.4 g in 1 TUBEGEL23.41
10122-310-02FILSUVEZ1 in 1 CARTONGEL11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10122-310-01GM - Gram10122-310abb317f9-237a-4585-9eb6-4a42536a3bf212024-06-10
10122-310-02GM - Gram10122-310ca5c32e7-de34-4524-9ce2-a7699709438412024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10122-310FILSUVEZ (BIRCH TRITERPENES) GEL [CHIESI USA, INC.]1Current NDC, 2 package rows20240522_32ba9194-734c-47d4-84e1-b21e28a85ec5.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FILSUVEZBIRCH TRITERPENESChiesi USA, Inc.32ba9194-734c-47d4-84e1-b21e28a85ec52026-07-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 215064
application number: NDA215064
ndc (product): 10122-310
FILSUVEZBIRCH TRITERPENESAmryt Pharmaceuticals DACda793f2d-0a3d-4792-8c22-982f9f8cdd972026-01-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 215064
application number: NDA215064

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2675587birch triterpenes 10 % Topical GelPSN32ba9194-734c-47d4-84e1-b21e28a85ec51
2675592Filsuvez 10 % Topical GelPSN32ba9194-734c-47d4-84e1-b21e28a85ec51
2675592birch triterpenes 0.1 MG/MG Topical Gel [Filsuvez]SBD32ba9194-734c-47d4-84e1-b21e28a85ec51
2675587birch triterpenes 0.1 MG/MG Topical GelSCD32ba9194-734c-47d4-84e1-b21e28a85ec51
2675587birch triterpenes 10 % Topical GelSY32ba9194-734c-47d4-84e1-b21e28a85ec51
2675592Filsuvez 0.1 MG/MG Topical GelSY32ba9194-734c-47d4-84e1-b21e28a85ec51
2675592Filsuvez 10 % Topical GelSY32ba9194-734c-47d4-84e1-b21e28a85ec51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10122-310-011012203100123.4 g in 1 TUBE23.4 gHistorical
10122-310-02101220310021 TUBE in 1 CARTON (10122-310-02) / 23.4 g in 1 TUBE (10122-310-01) 1 tube2024-02-22NoNoCurrent