Pegloticase Solution
NDC Package 84606-6824-1

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.

Pegloticase solution is pegloticase is used to treat gout which has not responded to the usual treatments. This formulation utilizes a solution delivery system. Marketed by Bio-technology General (israel) Ltd., this product is identified by NDC 84606-6824.

Identification & Billing

NDC Package Code
84606-6824-1
Package Description
1800 mL in 1 BOTTLE, GLASS
Product Code
84606-6824
11-Digit Billing Format
84606682401

Clinical Specifications

Proprietary Name
Pegloticase
Non-Proprietary Name
Pegloticase
Substance Name
Pegloticase
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Active Ingredient(s)
PEGLOTICASE 8 mg/mL
Usage Information
Pegloticase is used to treat gout which has not responded to the usual treatments. It works by lowering high levels of uric acid in your body. Increased uric acid in your body can cause gout.

Regulatory & Marketing

Labeler Name
Bio-technology General (israel) Ltd.
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
12-01-2010
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 84606-6824-1 identifies a specific commercial package of 1800 ml in 1 bottle, glass of Pegloticase (UNFINISHED drug), drug for further processing labeled by Bio-technology General (israel) Ltd.. This solution is formulated for use and contains pegloticase 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 Bio-technology General (israel) Ltd. on December 01, 2010. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Pegloticase is used to treat gout which has not responded to the usual treatments. It works by lowering high levels of uric acid in your body. Increased uric acid in your body can cause gout.

How is this Bio-technology General (israel) Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84606682401. 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 (5-4-1)
84606-6824-1
11-Digit CMS (5-4-2)
84606-6824-01

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