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NDC 69866-1025 Carticel

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 69866-1025?
  4. Carticel Uses
  5. Active Ingredients UNII Codes

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
69866-1025
Proprietary Name:
Carticel
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Vericel Corporation
Labeler Code:
69866
Product Label ID:
096cf052-6510-412a-abf3-24e5a33ea316
Start Marketing Date: [9]
06-19-1905
Listing Expiration Date: [11]
12-31-2018
Exclude Flag: [12]
I
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Product Details

What is NDC 69866-1025?

The NDC code 69866-1025 is assigned by the FDA to the product Carticel which is product labeled by Vericel Corporation. The product's dosage form is . The product is distributed in a single package with assigned NDC code 69866-1025-1 1 implant in 1 vial, glass . 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 Carticel?

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.

Which are Carticel 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)

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Product Footnotes

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

[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".