Nexobrid Kit
NDC Package 69866-2002-3

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

Package Information

Nexobrid (anacaulase-bcdb) kits is nEXOBRID is indicated for eschar removal in adults with deep partial thickness (DPT) and/or full thickness (FT) thermal burns.Limitations of UseThe safety and effectiveness of NEXOBRID have not been established for treatment of:Chemical or electrical burnsBurns on the face, perineum, or genitaliaBurns on the feet of patients with diabetes mellitus or on the feet of patients with occlusive vascular diseaseCircumferential burnsBurns in patients with significant cardiopulmonary disease, including inhalation injuryNEXOBRID is not recommended for wounds contaminated with radioactive and other hazardous substances to avoid unforeseeable reactions with the product and an increased risk of spreading the noxious substance. This formulation utilizes a kit delivery system. Marketed by Vericel Corporation, this product is identified by NDC 69866-2002 and is authorized under FDA application BLA761192.

Identification & Billing

NDC Package Code
69866-2002-3
Package Description
1 KIT in 1 CARTON * 20 g in 1 JAR (69866-2001-2) * 2 g in 1 VIAL, GLASS (69866-2000-1)
Product Code
69866-2002
11-Digit Billing Format
69866200203
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nexobrid
Non-Proprietary Name
Anacaulase-bcdb
Dosage Form
Kit - A packaged collection of related material.
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.
Usage Information
NEXOBRID is indicated for eschar removal in adults with deep partial thickness (DPT) and/or full thickness (FT) thermal burns.Limitations of UseThe safety and effectiveness of NEXOBRID have not been established for treatment of:Chemical or electrical burnsBurns on the face, perineum, or genitaliaBurns on the feet of patients with diabetes mellitus or on the feet of patients with occlusive vascular diseaseCircumferential burnsBurns in patients with significant cardiopulmonary disease, including inhalation injuryNEXOBRID is not recommended for wounds contaminated with radioactive and other hazardous substances to avoid unforeseeable reactions with the product and an increased risk of spreading the noxious substance.

Regulatory & Marketing

Labeler Name
Vericel Corporation
Product Type
Human Prescription Drug
FDA Application #
BLA761192
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
12-29-2022
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 69866-2002-3 identifies a specific commercial package of 1 kit in 1 carton * 20 g in 1 jar (69866-2001-2) * 2 g in 1 vial, glass (69866-2000-1) of Nexobrid, a human prescription drug labeled by Vericel Corporation. This kit is formulated for topical use and contains 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 Vericel Corporation on December 29, 2022. The current certification is valid through December 31, 2026.

How is this Vericel Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69866200203. 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 (5-4-1)
69866-2002-3
11-Digit CMS (5-4-2)
69866-2002-03

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