Icg
NDC Package 70599-424-02

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.

Icg is for Injection Set, a tricarbocyanine dye, is indicated for use with the KARL STORZ ICG Imaging System to provide real-time endoscopic visible and near-infrared fluorescence imaging. Marketed by Karl Storz Endoscopy-america, Inc., this product is identified by NDC 70599-424 and is authorized under FDA application ANDA040811.

Identification & Billing

NDC Package Code
70599-424-02
Package Description
6 PACKAGE in 1 CARTON / 1 KIT in 1 PACKAGE * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 10 mL in 1 VIAL, PLASTIC (0409-4887-17)
Product Code
70599-424
11-Digit Billing Format
70599042402

Clinical Specifications

Proprietary Name
Icg
Dosage Form
-
Usage Information
ICG for Injection Set, a tricarbocyanine dye, is indicated for use with the KARL STORZ ICG Imaging System to provide real-time endoscopic visible and near-infrared fluorescence imaging. Indocyanine Green for Injection, USP used in conjunction with the KARL STORZ ICG Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as:

Regulatory & Marketing

Labeler Name
Karl Storz Endoscopy-america, Inc.
FDA Application #
ANDA040811
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-01-2016
Listing Expiration
12-31-2021
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 70599-424-02 identifies a specific commercial package of 6 package in 1 carton / 1 kit in 1 package * 1 injection, powder, lyophilized, for solution in 1 vial * 10 ml in 1 vial, plastic (0409-4887-17) of Icg, labeled by Karl Storz Endoscopy-america, 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 Karl Storz Endoscopy-america, Inc. on June 01, 2016. The current certification is valid through December 31, 2021.

How is this Karl Storz Endoscopy-america, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70599042402. 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)
70599-424-02
11-Digit CMS (5-4-2)
70599-0424-02

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