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  5. NDC Package Code: 52958-034-01 Bivalirudin

NDC Package 52958-034-01 Bivalirudin

Injection, Powder, Lyophilized, For Solution 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:
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
Proprietary Name:
Bivalirudin
Non-Proprietary Name:
Bivalirudin
Substance Name:
Bivalirudin
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.
11-Digit NDC Billing Format:
52958003401
NDC to RxNorm Crosswalk:
  • RxCUI: 308769 - bivalirudin 250 MG Injection
  • RxCUI: 308769 - bivalirudin 250 MG (as bivalirudin trifluoroacetate 275 MG) per 5 ML Injection
  • RxCUI: 308769 - bivalirudin 50 MG/ML Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Hainan Shuangcheng Pharmaceuticals Co., Ltd.
    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(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • BIVALIRUDIN 250 mg/1
    • Pharmacologic Class(es):
  • Anti-coagulant - [EPC] (Established Pharmacologic Class)
  • Direct Thrombin Inhibitor - [EPC] (Established Pharmacologic Class)
  • Thrombin Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA210031
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-23-2019
    Listing Expiration Date:
    12-31-2024
    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 52958-034-01?

    The NDC Packaged Code 52958-034-01 is assigned to a 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.. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form.

    Is NDC 52958-034 included in the NDC Directory?

    Yes, Bivalirudin with product code 52958-034 is active and included in the NDC Directory. The product was first marketed by Hainan Shuangcheng Pharmaceuticals Co., Ltd. on October 23, 2019 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 52958-034-01?

    The 11-digit format is 52958003401. 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
    5-3-252958-034-015-4-252958-0034-01