Carticel
NDC Package 69866-1025-1

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Carticel is ® is indicated for the repair of symptomatic cartilage defects of the femoral condyle (medial, lateral or trochlea), caused by acute or repetitive trauma, in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure (e.g., debridement, microfracture, drilling/abrasion arthroplasty, or osteochondral allograft/autograft).Carticel should be used only in conjunction with debridement, placement of a periosteal flap and rehabilitation. Marketed by Vericel Corporation, this product is identified by NDC 69866-1025 and is authorized under FDA application BLA103661.

Identification & Billing

NDC Package Code
69866-1025-1
Package Description
1 IMPLANT in 1 VIAL, GLASS
Product Code
69866-1025
11-Digit Billing Format
69866102501
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Carticel
Dosage Form
-
Usage Information
Carticel® is indicated for the repair of symptomatic cartilage defects of the femoral condyle (medial, lateral or trochlea), caused by acute or repetitive trauma, in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure (e.g., debridement, microfracture, drilling/abrasion arthroplasty, or osteochondral allograft/autograft).Carticel should be used only in conjunction with debridement, placement of a periosteal flap and rehabilitation. The independent contributions of the autologous cultured chondrocytes and other components of the therapy to outcome are unknown. Carticel is not indicated for the treatment of cartilage damage associated with generalized osteoarthritis.Carticel is not recommended for patients with total meniscectomy unless surgically reconstructed prior to or concurrent with Carticel implantation.

Regulatory & Marketing

Labeler Name
Vericel Corporation
FDA Application #
BLA103661
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
06-19-1905
Listing Expiration
12-31-2018
Exclude Flag
I
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 69866-1025-1 identifies a specific commercial package of 1 implant in 1 vial, glass of Carticel, labeled by Vericel Corporation. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Vericel Corporation on June 19, 1905. The current certification is valid through December 31, 2018.

How is this Vericel Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69866102501. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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 (5-4-1)
69866-1025-1
11-Digit CMS (5-4-2)
69866-1025-01

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