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  5. NDC Package Code: 55513-760-03 Repatha

NDC Package 55513-760-03 Repatha

Evolocumab Injection, Solution Subcutaneous - 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:
55513-760-03
Package Description:
3 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE
Product Code:
55513-760
Proprietary Name:
Repatha
Non-Proprietary Name:
Evolocumab
Substance Name:
Evolocumab
Usage Information:
Evolocumab is used to help lower "bad" cholesterol (LDL) in the blood. For people who have high levels of LDL, it is used along with a proper diet, alone or other LDL-lowering treatments (such as "statin" drugs, ezetimibe, LDL apheresis). Evolocumab is also used by people who have heart disease to help prevent heart attacks and strokes. This medication belongs to a class of drugs known as monoclonal antibodies. It works by improving how well your body gets rid of LDL cholesterol. In addition to eating a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help this medication work better include exercising, losing weight if overweight, and stopping smoking. Consult your doctor for more details.
11-Digit NDC Billing Format:
55513076003
NDC to RxNorm Crosswalk:
  • RxCUI: 1665895 - evolocumab 140 MG in 1 ML Auto-Injector
  • RxCUI: 1665895 - 1 ML evolocumab 140 MG/ML Auto-Injector
  • RxCUI: 1665900 - Repatha 140 MG in 1 ML Auto-Injector
  • RxCUI: 1665900 - 1 ML evolocumab 140 MG/ML Auto-Injector [Repatha]
  • RxCUI: 1665900 - 1 ML Repatha 140 MG/ML Auto-Injector
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Amgen Inc
    Dosage Form:
    Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
    Administration Route(s):
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Active Ingredient(s):
  • EVOLOCUMAB 140 mg/mL
    • Pharmacologic Class(es):
  • Antibodies, Monoclonal - [CS]
  • PCSK9 Inhibitor - [EPC] (Established Pharmacologic Class)
  • PCSK9 Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    BLA125522
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    08-31-2015
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    55513-760-011 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE
    55513-760-022 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE
    55513-760-911 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 55513-760-03?

    The NDC Packaged Code 55513-760-03 is assigned to a package of 3 syringe in 1 carton / 1 ml in 1 syringe of Repatha, a human prescription drug labeled by Amgen Inc. The product's dosage form is injection, solution and is administered via subcutaneous form.

    Is NDC 55513-760 included in the NDC Directory?

    Yes, Repatha with product code 55513-760 is active and included in the NDC Directory. The product was first marketed by Amgen Inc on August 31, 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 11-digit format for NDC 55513-760-03?

    The 11-digit format is 55513076003. 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
    5-3-255513-760-035-4-255513-0760-03