Juxtapid Capsule
NDC Package 10122-430-28

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Juxtapid (lomitapide mesylate) capsules is a medication used along with a low-fat diet and other treatments for a certain inherited condition that causes very high cholesterol levels (homozygous familial hypercholesterolemia). This formulation utilizes a capsule delivery system. Marketed by Chiesi Usa, Inc., this product is identified by NDC 10122-430 and is authorized under FDA application NDA203858.

Identification & Billing

NDC Package Code
10122-430-28
Package Description
28 CAPSULE in 1 BOTTLE
Product Code
10122-430
11-Digit Billing Format
10122043028
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
28 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Juxtapid
Non-Proprietary Name
Lomitapide Mesylate
Substance Name
Lomitapide Mesylate
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
LOMITAPIDE MESYLATE 30 mg/1
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Chiesi Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA203858
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-03-2013
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 10122-430-28 identifies a specific commercial package of 28 capsule in 1 bottle of Juxtapid, a human prescription drug labeled by Chiesi Usa, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 28 billable units per package. This capsule is formulated for oral use and contains lomitapide mesylate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Chiesi Usa, Inc. on January 03, 2013. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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.

How is this Chiesi Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10122043028. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 28 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
10122-430-28
11-Digit CMS (5-4-2)
10122-0430-28

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.