filsuvez

Generic: birch triterpenes

Labeler: chiesi usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name filsuvez
Generic Name birch triterpenes
Labeler chiesi usa, inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

birch triterpenes 100 mg/g

Manufacturer
Chiesi USA, Inc.

Identifiers & Regulatory

Product NDC 10122-310
Product ID 10122-310_0b380ed5-013d-47af-8113-4d708bb92180
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215064
Listing Expiration 2026-12-31
Marketing Start 2024-02-22

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10122310
Hyphenated Format 10122-310

Supplemental Identifiers

RxCUI
2675587 2675592
UNII
BX09B0RQR0

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name filsuvez (source: ndc)
Generic Name birch triterpenes (source: ndc)
Application Number NDA215064 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (10122-310-02) / 23.4 g in 1 TUBE (10122-310-01)
source: ndc

Packages (1)

10122-310-02 1 TUBE in 1 CARTON (10122-310-02) / 23.4 g in 1 TUBE (10122-310-01)

Ingredients (1)

birch triterpenes (100 mg/g)

Linked Drug Pages (1)

FILSUVEZ ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "0b380ed5-013d-47af-8113-4d708bb92180", "openfda": {"unii": ["BX09B0RQR0"], "rxcui": ["2675587", "2675592"], "spl_set_id": ["32ba9194-734c-47d4-84e1-b21e28a85ec5"], "manufacturer_name": ["Chiesi USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (10122-310-02)  / 23.4 g in 1 TUBE (10122-310-01)", "package_ndc": "10122-310-02", "marketing_start_date": "20240222"}], "brand_name": "FILSUVEZ", "product_id": "10122-310_0b380ed5-013d-47af-8113-4d708bb92180", "dosage_form": "GEL", "product_ndc": "10122-310", "generic_name": "birch triterpenes", "labeler_name": "Chiesi USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FILSUVEZ", "active_ingredients": [{"name": "BIRCH TRITERPENES", "strength": "100 mg/g"}], "application_number": "NDA215064", "marketing_category": "NDA", "marketing_start_date": "20240222", "listing_expiration_date": "20261231"}