Krystexxa
NDC Package 54396-801-01

11-digit billing NDC: 54396080101 · Billing unit: ML · 1 ML per package
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.

Krystexxa is ® (pegloticase) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.Gout refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.Important Limitations of Use:KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia. Marketed by Savient Pharmaceuticals, Inc., this product is identified by NDC 54396-801 and is authorized under FDA application BLA125293.

Identification & Billing

NDC Package Code
54396-801-01
Package Description
1 VIAL in 1 CARTON / 1 mL in 1 VIAL
Product Code
54396-801
11-Digit Billing Format
54396080101
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
1 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Krystexxa
Dosage Form
-
Usage Information
KRYSTEXXA® (pegloticase) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.Gout refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.Important Limitations of Use:KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.

Regulatory & Marketing

Labeler Name
Savient Pharmaceuticals, Inc.
FDA Application #
BLA125293
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
09-14-2010
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 54396-801-01 identifies a specific commercial package of 1 vial in 1 carton / 1 ml in 1 vial of Krystexxa, labeled by Savient Pharmaceuticals, Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 1 billable units per package. 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 Savient Pharmaceuticals, Inc. on September 14, 2010. The current certification is valid through December 31, 2017.

How is this Savient Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54396080101. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 1 total billable units per package. 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)
54396-801-01
11-Digit CMS (5-4-2)
54396-0801-01

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