Gintuit
NDC Package 42606-004-01

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.

Gintuit is (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. Marketed by Organogenesis, Inc, this product is identified by NDC 42606-004 and is authorized under FDA application BLA125400.

Identification & Billing

NDC Package Code
42606-004-01
Package Description
44.2 cm2 in 1 TRAY
Product Code
42606-004
11-Digit Billing Format
42606000401

Clinical Specifications

Proprietary Name
Gintuit
Dosage Form
-
Usage Information
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.

Regulatory & Marketing

Labeler Name
Organogenesis, Inc
FDA Application #
BLA125400
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
03-15-2012
Listing Expiration
12-31-2017
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 42606-004-01 identifies a specific commercial package of 44.2 cm2 in 1 tray of Gintuit, labeled by Organogenesis, Inc. 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 Organogenesis, Inc on March 15, 2012. The current certification is valid through December 31, 2017.

How is this Organogenesis, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42606000401. 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 (5-3-2)
42606-004-01
11-Digit CMS (5-4-2)
42606-0004-01

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