Bivalirudin Injection, Powder, Lyophilized, For Solution
NDC Package 52958-034-01

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

Package Information

Bivalirudin injection is 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. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Hainan Shuangcheng Pharmaceuticals Co., Ltd., this product is identified by NDC 52958-034 and is authorized under FDA application ANDA210031.

Identification & Billing

NDC Package Code
52958-034-01
Package Description
10 VIAL, SINGLE-USE in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE
Product Code
52958-034
11-Digit Billing Format
52958003401
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Bivalirudin
Non-Proprietary Name
Bivalirudin
Substance Name
Bivalirudin
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
BIVALIRUDIN 250 mg/1
Pharmacologic Class
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
Hainan Shuangcheng Pharmaceuticals Co., Ltd.
Product Type
Human Prescription Drug
FDA Application #
ANDA210031
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-23-2019
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 52958-034-01 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, a human prescription drug labeled by Hainan Shuangcheng Pharmaceuticals Co., Ltd.. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains bivalirudin 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 Hainan Shuangcheng Pharmaceuticals Co., Ltd. on October 23, 2019. The current certification is valid through December 31, 2026.

How is this Hainan Shuangcheng Pharmaceuticals Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52958003401. 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)
52958-034-01
11-Digit CMS (5-4-2)
52958-0034-01

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