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  5. NDC Package Code: 70436-025-80 Bivalirudin

NDC Package 70436-025-80 Bivalirudin

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

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
70436-025-80
Package Description:
1 INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION in 1 VIAL, SINGLE-DOSE
Product Code:
70436-025
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:
70436002580
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 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:
    Slate Run Pharmaceuticals, Llc
    Dosage Form:
    Injection, Powder, Lyophilized, For Suspension - A liquid preparation, intended for parenteral use that contains solids suspended in a suitable fluid medium and conforms in all respects to the requirements for Sterile Suspensions; the medicinal agents intended for the suspension are prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures.
    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:
    ANDA213078
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-30-2021
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    70436-025-8210 INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION in 1 CARTON

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 70436-025-80?

    The NDC Packaged Code 70436-025-80 is assigned to a package of 1 injection, powder, lyophilized, for suspension in 1 vial, single-dose of Bivalirudin, a human prescription drug labeled by Slate Run Pharmaceuticals, Llc. The product's dosage form is injection, powder, lyophilized, for suspension and is administered via intravenous form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 70436-025 included in the NDC Directory?

    Yes, Bivalirudin with product code 70436-025 is active and included in the NDC Directory. The product was first marketed by Slate Run Pharmaceuticals, Llc on June 30, 2021 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 70436-025-80?

    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 1.

    What is the 11-digit format for NDC 70436-025-80?

    The 11-digit format is 70436002580. 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
    5-3-270436-025-805-4-270436-0025-80