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NDC 69866-1030 Maci

Autologous Cultured Chondrocytes Implant Intra-articular - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 69866-1030?
  4. Maci Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Pharmacologic Classes

Product Information

NDC Product Code:
69866-1030
Proprietary Name:
Maci
Non-Proprietary Name: [1]
Autologous Cultured Chondrocytes
Substance Name: [2]
Autologous Cultured Chondrocytes; Pork Collagen
NDC Directory Status:
Cellular Therapy
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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(s): [4]
  • Intra-articular - Administration within a joint.
    • Labeler Name: [5]
    Vericel Corporation
    Labeler Code:
    69866
    Product Label ID:
    0c336c02-8c4c-4aa8-a992-9d2890a2539c
    FDA Application Number: [6]
    BLA125603
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    06-09-2017
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Code Structure Chart

    Product Details

    What is NDC 69866-1030?

    The NDC code 69866-1030 is assigned by the FDA to the product Maci which is a cellular therapy product labeled by Vericel Corporation. The generic name of Maci is autologous cultured chondrocytes. The product's dosage form is implant and is administered via intra-articular form. The product is distributed in 2 packages with assigned NDC codes 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), 69866-1030-8 2 bag in 1 box / 1 bottle, plastic in 1 bag (69866-1030-7) / 1 implant in 1 bottle, plastic (69866-1030-6). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Maci?

    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.

    What are Maci Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are Maci UNII Codes?

    The UNII codes for the active ingredients in this product are:

    • AUTOLOGOUS CULTURED CHONDROCYTES (UNII: D5P3K3V822)
    • AUTOLOGOUS CULTURED CHONDROCYTES (UNII: D5P3K3V822) (Active Moiety)
    • PORK COLLAGEN (UNII: I8442U2G7J)
    • PORK COLLAGEN (UNII: I8442U2G7J) (Active Moiety)

    Which are the Pharmacologic Classes for Maci?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".