Maci Implant
NDC Package 69866-1030-8

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

Package Information

Maci (autologous cultured chondrocytes) implants is mACI® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of single or multiple symptomatic, full-thickness cartilage defects of the knee with or without bone involvement in adults.Limitations of UseEffectiveness of MACI in joints other than the knee has not been established.Safety and effectiveness of MACI in patients over the age of 55 years have not been established. This formulation utilizes a implant delivery system. Marketed by Vericel Corporation, this product is identified by NDC 69866-1030 and is authorized under FDA application BLA125603.

Identification & Billing

NDC Package Code
69866-1030-8
Package Description
2 BAG in 1 BOX / 1 BOTTLE, PLASTIC in 1 BAG (69866-1030-7) / 1 IMPLANT in 1 BOTTLE, PLASTIC (69866-1030-6)
Product Code
69866-1030
11-Digit Billing Format
69866103008
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
2 EA

Clinical Specifications

Proprietary Name
Maci
Non-Proprietary Name
Autologous Cultured Chondrocytes
Substance Name
Autologous Cultured Chondrocytes; Pork Collagen
Dosage Form
Implant - A material containing drug intended to be inserted securely of deeply in a living site for growth, slow release, or formation of an organic union.
Administration Route
Intra-articular - Administration within a joint.
Active Ingredient(s)
Pharmacologic Class
Usage Information
MACI® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of single or multiple symptomatic, full-thickness cartilage defects of the knee with or without bone involvement in adults.Limitations of UseEffectiveness of MACI in joints other than the knee has not been established.Safety and effectiveness of MACI in patients over the age of 55 years have not been established.

Regulatory & Marketing

Labeler Name
Vericel Corporation
Product Type
Cellular Therapy
FDA Application #
BLA125603
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
06-09-2017
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (69866-1030). Click a package code to view its specific billing and regulatory data.

69866-1030-5
1 BAG in 1 BOX / 1 BOTTLE, PLASTIC in 1 BAG (69866-1030-4) / 1 IMPLANT in 1 BOTTLE, PLASTIC (69866-1030-3)

* 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 69866-1030-8 identifies a specific commercial package of 2 bag in 1 box / 1 bottle, plastic in 1 bag (69866-1030-7) / 1 implant in 1 bottle, plastic (69866-1030-6) of Maci, a cellular therapy labeled by Vericel Corporation. This product is billed for "EA" each discreet unit and contains an estimated amount of 2 billable units per package. This implant is formulated for intra-articular use and contains autologous cultured chondrocytes; pork collagen 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 June 09, 2017. The current certification is valid through December 31, 2027.

How is this Vericel Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69866103008. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 2 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)
69866-1030-8
11-Digit CMS (5-4-2)
69866-1030-08

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