Praxbind Injection
NDC Package 0597-0197-05

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Praxbind (idarucizumab) injection is 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. This formulation utilizes a injection delivery system. Marketed by Boehringer Ingelheim Pharmaceuticals, Inc., this product is identified by NDC 0597-0197 and is authorized under FDA application BLA761025.

Identification & Billing

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
11-Digit Billing Format
00597019705
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Praxbind
Non-Proprietary Name
Idarucizumab
Substance Name
Idarucizumab
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
IDARUCIZUMAB 50 mg/mL
Pharmacologic Class
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

Regulatory & Marketing

Labeler Name
Boehringer Ingelheim Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761025
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
10-21-2015
Listing Expiration
12-31-2026
Exclude Flag
N
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 0597-0197-05 identifies a specific commercial 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.. This injection is formulated for intravenous use and contains idarucizumab 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 Boehringer Ingelheim Pharmaceuticals, Inc. on October 21, 2015. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00597019705. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (4-4-2)
0597-0197-05
11-Digit CMS (5-4-2)
00597-0197-05

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