Filsuvez Gel
NDC Package 10122-310-02

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Filsuvez (birch triterpenes) gel is fILSUVEZ is indicated for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in adult and pediatric patients 6 months of age and older. This formulation utilizes a gel delivery system. Marketed by Chiesi Usa, Inc., this product is identified by NDC 10122-310 and is authorized under FDA application NDA215064.

Identification & Billing

NDC Package Code
10122-310-02
Package Description
1 TUBE in 1 CARTON / 23.4 g in 1 TUBE (10122-310-01)
Product Code
10122-310
11-Digit Billing Format
10122031002
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
23.4 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Filsuvez
Non-Proprietary Name
Birch Triterpenes
Substance Name
Birch Triterpenes
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
BIRCH TRITERPENES 100 mg/g
Usage Information
FILSUVEZ is indicated for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in adult and pediatric patients 6 months of age and older.

Regulatory & Marketing

Labeler Name
Chiesi Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA215064
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-22-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 10122-310-02 identifies a specific commercial package of 1 tube in 1 carton / 23.4 g in 1 tube (10122-310-01) of Filsuvez, a human prescription drug labeled by Chiesi Usa, Inc.. This product is billed per "GM" gram and contains an estimated amount of 23.4 billable units per package. This gel is formulated for topical use and contains birch triterpenes as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Chiesi Usa, Inc. on February 22, 2024. The current certification is valid through December 31, 2026.

How is this Chiesi Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10122031002. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 23.4 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
10122-310-02
11-Digit CMS (5-4-2)
10122-0310-02

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.