Glucarpidase Liquid
NDC Package 76356-101-01

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Glucarpidase liquids is a bulk ingredient utilized for pharmaceutical compounding or manufacturing. This formulation utilizes a liquid delivery system. Marketed by Kaneka Eurogentec Sa, this product is identified by NDC 76356-101.

Identification & Billing

NDC Package Code
76356-101-01
Package Description
10000 mL in 1 PACKAGE
Product Code
76356-101
11-Digit Billing Format
76356010101

Clinical Specifications

Proprietary Name
Glucarpidase
Non-Proprietary Name
Glucarpidase
Substance Name
Glucarpidase
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Active Ingredient(s)
GLUCARPIDASE 1000 U/mL

Regulatory & Marketing

Labeler Name
Kaneka Eurogentec Sa
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING - A category specifying that a bulk product is intended for use on humans and requires a prescription.
Start Marketing Date
11-02-2015
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 76356-101-01 identifies a specific commercial package of 10000 ml in 1 package of Glucarpidase (UNFINISHED drug), a bulk ingredient labeled by Kaneka Eurogentec Sa. This liquid is formulated for use and contains glucarpidase 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 Kaneka Eurogentec Sa on November 02, 2015. The current certification is valid through December 31, 2026.

How is this Kaneka Eurogentec Sa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76356010101. 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)
76356-101-01
11-Digit CMS (5-4-2)
76356-0101-01

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