Indocyanine Green Kit
NDC Package 70100-424-02

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Indocyanine Green (indocyanine green and water) kits is indocyanine Green for injection is indicated:. This formulation utilizes a kit delivery system. Marketed by Renew Pharmaceuticals Limited, this product is identified by NDC 70100-424 and is authorized under FDA application ANDA040811.

Identification & Billing

NDC Package Code
70100-424-02
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
70100-424
11-Digit Billing Format
70100042402
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.

Clinical Specifications

Proprietary Name
Indocyanine Green
Non-Proprietary Name
Indocyanine Green And Water
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Indocyanine Green for injection is indicated:

Regulatory & Marketing

Labeler Name
Renew Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA040811
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-01-2008
Listing Expiration
12-31-2026
Exclude Flag
N
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 70100-424-02 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 Indocyanine Green, a human prescription drug labeled by Renew Pharmaceuticals Limited. This kit is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Renew Pharmaceuticals Limited on January 01, 2008. The current certification is valid through December 31, 2026.

How is this Renew Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70100042402. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
70100-424-02
11-Digit CMS (5-4-2)
70100-0424-02

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