Bivalirudin
NDC Package 75929-217-01

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 EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Bivalirudin is for injection is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome. Marketed by Pharma Packaging Solutions, Llc Dba Tjoapack Llc, this product is identified by NDC 75929-217 and is authorized under FDA application NDA020873.

Identification & Billing

NDC Package Code
75929-217-01
Package Description
10 VIAL, SINGLE-USE in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE
Product Code
75929-217
11-Digit Billing Format
75929021701
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Bivalirudin
Dosage Form
-
Usage Information
Bivalirudin for injection is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome.

Regulatory & Marketing

Labeler Name
Pharma Packaging Solutions, Llc Dba Tjoapack Llc
FDA Application #
NDA020873
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
12-21-2020
Listing Expiration
12-31-2025
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 75929-217-01 identifies a specific commercial package of 10 vial, single-use in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-use of Bivalirudin, labeled by Pharma Packaging Solutions, Llc Dba Tjoapack Llc. 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 Pharma Packaging Solutions, Llc Dba Tjoapack Llc on December 21, 2020. The current certification is valid through December 31, 2025.

How is this Pharma Packaging Solutions, Llc Dba Tjoapack Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 75929021701. 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)
75929-217-01
11-Digit CMS (5-4-2)
75929-0217-01

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