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  5. NDC Package Code: 75987-080-10 Krystexxa

NDC Package 75987-080-10 Krystexxa

Pegloticase Injection, Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
75987-080-10
Package Description:
1 VIAL in 1 CARTON / 1 mL in 1 VIAL
Product Code:
75987-080
Proprietary Name:
Krystexxa
Non-Proprietary Name:
Pegloticase
Substance Name:
Pegloticase
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.
11-Digit NDC Billing Format:
75987008010
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1011653 - pegloticase 8 MG in 1 ML Injection
  • RxCUI: 1011653 - 1 ML pegloticase 8 MG/ML Injection
  • RxCUI: 1011653 - pegloticase (as uricase protein) 8 MG per 1 ML Injection
  • RxCUI: 1011653 - pegloticase 8 MG per 1 ML Injection
  • RxCUI: 1011657 - Krystexxa 8 MG in 1 ML Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Horizon Therapeutics Usa, Inc.
    Dosage Form:
    Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • PEGLOTICASE 8 mg/mL
    • Pharmacologic Class(es):
  • Urate Oxidase - [CS]
  • Uric Acid-specific Enzyme - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    BLA125293
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    09-14-2010
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 75987-080-10 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    75987008010J2507Pegloticase injection1 MG1188

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 75987-080-10?

    The NDC Packaged Code 75987-080-10 is assigned to a package of 1 vial in 1 carton / 1 ml in 1 vial of Krystexxa, a human prescription drug labeled by Horizon Therapeutics Usa, Inc.. The product's dosage form is injection, solution and is administered via intravenous form.

    Is NDC 75987-080 included in the NDC Directory?

    Yes, Krystexxa with product code 75987-080 is active and included in the NDC Directory. The product was first marketed by Horizon Therapeutics Usa, Inc. on September 14, 2010 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 75987-080-10?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 75987-080-10?

    The 11-digit format is 75987008010. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-275987-080-105-4-275987-0080-10