NDC 42606-004 Gintuit

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
42606-004
Proprietary Name:
Gintuit
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Organogenesis, Inc
Labeler Code:
42606
Start Marketing Date: [9]
03-15-2012
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Packages

NDC Code 42606-004-01

Package Description: 44.2 cm2 in 1 TRAY

Product Details

What is NDC 42606-004?

The NDC code 42606-004 is assigned by the FDA to the product Gintuit which is product labeled by Organogenesis, Inc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 42606-004-01 44.2 cm2 in 1 tray . 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 Gintuit?

GINTUIT (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen) is an allogeneic cellularized scaffold product indicated for topical (non-submerged) application to a surgically created vascular wound bed in the treatment of mucogingival conditions in adults.GINTUIT is not intended to provide root coverage.

Which are Gintuit UNII Codes?

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

  • FORESKIN FIBROBLAST (NEONATAL) (UNII: T34C307W5N)
  • FORESKIN FIBROBLAST (NEONATAL) (UNII: T34C307W5N) (Active Moiety)
  • BOVINE TYPE I COLLAGEN (UNII: FHJ3ATL51C)
  • BOVINE TYPE I COLLAGEN (UNII: FHJ3ATL51C) (Active Moiety)
  • FORESKIN KERATINOCYTE (NEONATAL) (UNII: ZJO8CP3Q2A)
  • FORESKIN KERATINOCYTE (NEONATAL) (UNII: ZJO8CP3Q2A) (Active Moiety)

* Please review the disclaimer below.

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".