NDC Package 0409-8300-15 Bivalirudin

Injection, Powder, Lyophilized, For Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

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:
0409-8300-15
Package Description:
10 VIAL, PATENT DELIVERY SYSTEM in 1 TRAY / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM (0409-8300-25)
Product Code:
Proprietary Name:
Bivalirudin
Non-Proprietary Name:
Bivalirudin
Substance Name:
Bivalirudin
Usage Information:
Bivalirudin 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:
00409830015
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
10 EA
Product Type:
Human Prescription Drug
Labeler Name:
Hospira, Inc.
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):
    Sample Package:
    No
    FDA Application Number:
    ANDA090811
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-30-2015
    End Marketing Date:
    08-01-2024
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0409-8300-1010 VIAL, SINGLE-DOSE in 1 TRAY / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0409-8300-20)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0409-8300-15?

    The NDC Packaged Code 0409-8300-15 is assigned to a package of 10 vial, patent delivery system in 1 tray / 1 injection, powder, lyophilized, for solution in 1 vial, patent delivery system (0409-8300-25) of Bivalirudin, a human prescription drug labeled by Hospira, Inc.. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form.This product is billed for "EA" each discreet unit and contains an estimated amount of 10 billable units per package.

    Is NDC 0409-8300 included in the NDC Directory?

    Yes, Bivalirudin with product code 0409-8300 is active and included in the NDC Directory. The product was first marketed by Hospira, Inc. on July 30, 2015.

    What is the NDC billing unit for package 0409-8300-15?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 10.

    What is the 11-digit format for NDC 0409-8300-15?

    The 11-digit format is 00409830015. 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
    4-4-20409-8300-155-4-200409-8300-15