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  5. NDC Package Code: 0597-0197-05 Praxbind

NDC Package 0597-0197-05 Praxbind

Idarucizumab Injection Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
0597-0197-05
Package Description:
2 VIAL, SINGLE-DOSE in 1 CARTON / 50 mL in 1 VIAL, SINGLE-DOSE
Product Code:
0597-0197
Proprietary Name:
Praxbind
Non-Proprietary Name:
Idarucizumab
Substance Name:
Idarucizumab
Usage Information:
PRAXBIND is indicated in patients treated with Pradaxa when reversal of the anticoagulant effects of dabigatran is needed:For emergency surgery/urgent proceduresIn life-threatening or uncontrolled bleeding
11-Digit NDC Billing Format:
00597019705
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1716195 - idaruCIZUmab 2.5 GM in 50 ML Injection
  • RxCUI: 1716195 - 50 ML idarucizumab 50 MG/ML Injection
  • RxCUI: 1716195 - idarucizumab 2.5 GM per 50 ML Injection
  • RxCUI: 1716200 - Praxbind 2.5 GM in 50 ML Injection
  • RxCUI: 1716200 - 50 ML idarucizumab 50 MG/ML Injection [Praxbind]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Boehringer Ingelheim Pharmaceuticals, Inc.
    Dosage Form:
    Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • IDARUCIZUMAB 50 mg/mL
    • Pharmacologic Class(es):
  • Antibodies, Monoclonal, Humanized - [CS]
  • Humanized Monoclonal Antibody Fragment - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    BLA761025
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    10-21-2015
    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.

    Frequently Asked Questions

    What is NDC 0597-0197-05?

    The NDC Packaged Code 0597-0197-05 is assigned to a package of 2 vial, single-dose in 1 carton / 50 ml in 1 vial, single-dose of Praxbind, a human prescription drug labeled by Boehringer Ingelheim Pharmaceuticals, Inc.. The product's dosage form is injection and is administered via intravenous form.

    Is NDC 0597-0197 included in the NDC Directory?

    Yes, Praxbind with product code 0597-0197 is active and included in the NDC Directory. The product was first marketed by Boehringer Ingelheim Pharmaceuticals, Inc. on October 21, 2015 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 0597-0197-05?

    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 0597-0197-05?

    The 11-digit format is 00597019705. 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 4-4-2 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
    4-4-20597-0197-055-4-200597-0197-05