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  5. NDC Package Code: 76431-110-01 Juxtapid

NDC Package 76431-110-01 Juxtapid

Lomitapide Mesylate Capsule Oral - 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:
76431-110-01
Package Description:
28 CAPSULE in 1 BOTTLE
Product Code:
76431-110
Proprietary Name:
Juxtapid
Non-Proprietary Name:
Lomitapide Mesylate
Substance Name:
Lomitapide Mesylate
Usage Information:
This medication is used along with a low-fat diet and other treatments for a certain inherited condition that causes very high cholesterol levels (homozygous familial hypercholesterolemia). Very high cholesterol levels increase your risk of developing heart and blood vessel disease. Lomitapide works by decreasing your body's production of cholesterol.
11-Digit NDC Billing Format:
76431011001
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
28 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1364484 - lomitapide 10 MG Oral Capsule
  • RxCUI: 1364484 - lomitapide (as lomitapide mesylate) 10 MG Oral Capsule
  • RxCUI: 1364490 - Juxtapid 10 MG Oral Capsule
  • RxCUI: 1364490 - lomitapide 10 MG Oral Capsule [Juxtapid]
  • RxCUI: 1364490 - Juxtapid (as lomitapide mesylate) 10 MG Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Amryt Pharmaceuticals Dac
    Dosage Form:
    Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • LOMITAPIDE MESYLATE 10 mg/1
    • Pharmacologic Class(es):
  • Cytochrome P450 3A4 Inhibitors - [MoA] (Mechanism of Action)
  • Microsomal Triglyceride Transfer Protein Inhibitor - [EPC] (Established Pharmacologic Class)
  • Microsomal Triglyceride Transfer Protein Inhibitors - [MoA] (Mechanism of Action)
  • P-Glycoprotein Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA203858
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    01-03-2013
    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 76431-110-01?

    The NDC Packaged Code 76431-110-01 is assigned to a package of 28 capsule in 1 bottle of Juxtapid, a human prescription drug labeled by Amryt Pharmaceuticals Dac. The product's dosage form is capsule and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 28 billable units per package.

    Is NDC 76431-110 included in the NDC Directory?

    Yes, Juxtapid with product code 76431-110 is active and included in the NDC Directory. The product was first marketed by Amryt Pharmaceuticals Dac on January 03, 2013 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 76431-110-01?

    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 28.

    What is the 11-digit format for NDC 76431-110-01?

    The 11-digit format is 76431011001. 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
    5-3-276431-110-015-4-276431-0110-01