NDC Package 0781-9158-95 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:
0781-9158-95
Package Description:
10 VIAL, SINGLE-USE in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (0781-9158-94)
Product Code:
Proprietary Name:
Bivalirudin
Non-Proprietary Name:
Bivalirudin
Substance Name:
Bivalirudin
Usage Information:
Bivalirudin is contraindicated in patients with:Active major bleeding;Hypersensitivity (e.g., anaphylaxis) to Bivalirudin or its components [see Adverse Reactions (6.3)].
11-Digit NDC Billing Format:
00781915895
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
10 EA
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:
    Sandoz 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:
    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:
    10-23-2015
    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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 0781-9158-95 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    00781915895J0583Bivalirudin1 MG1102502500

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0781-9158-95?

    The NDC Packaged Code 0781-9158-95 is assigned to a package of 10 vial, single-use in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-use (0781-9158-94) of Bivalirudin, a human prescription drug labeled by Sandoz 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 0781-9158 included in the NDC Directory?

    Yes, Bivalirudin with product code 0781-9158 is active and included in the NDC Directory. The product was first marketed by Sandoz Inc on October 23, 2015 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 NDC billing unit for package 0781-9158-95?

    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 0781-9158-95?

    The 11-digit format is 00781915895. 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
    4-4-20781-9158-955-4-200781-9158-95