filsuvez

Generic: birch triterpenes

Labeler: amryt pharmaceuticals dac
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name filsuvez
Generic Name birch triterpenes
Labeler amryt pharmaceuticals dac
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

birch triterpenes 100 mg/g

Manufacturer
Amryt Pharmaceuticals DAC

Identifiers & Regulatory

Product NDC 76431-310
Product ID 76431-310_59bc2507-59e9-48c0-8c87-f65bb0f32258
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215064
Marketing Start 2024-02-22
Marketing End 2028-06-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76431310
Hyphenated Format 76431-310

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 (76431-310-01) / 23.4 g in 1 TUBE
source: ndc

Packages (1)

76431-310-01 1 TUBE in 1 CARTON (76431-310-01) / 23.4 g in 1 TUBE

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": "59bc2507-59e9-48c0-8c87-f65bb0f32258", "openfda": {"unii": ["BX09B0RQR0"], "rxcui": ["2675587", "2675592"], "spl_set_id": ["da793f2d-0a3d-4792-8c22-982f9f8cdd97"], "manufacturer_name": ["Amryt Pharmaceuticals DAC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (76431-310-01)  / 23.4 g in 1 TUBE", "package_ndc": "76431-310-01", "marketing_end_date": "20280601", "marketing_start_date": "20240222"}], "brand_name": "FILSUVEZ", "product_id": "76431-310_59bc2507-59e9-48c0-8c87-f65bb0f32258", "dosage_form": "GEL", "product_ndc": "76431-310", "generic_name": "birch triterpenes", "labeler_name": "Amryt Pharmaceuticals DAC", "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_end_date": "20280601", "marketing_start_date": "20240222"}