Juxtapid
NDC 76431-130
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
Juxtapid is a NDA-approved product labeled by Amryt Pharmaceuticals Dac. 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). It is supplied as a orange product. This product entry covers the primary NDC 76431-130 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
76431-130
Proprietary Name:
Juxtapid
Product Type: [3]
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
76431
Product Label ID:
FDA Application Number: [6]
NDA203858
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
01-03-2013
End Marketing Date: [10]
07-29-2025
Listing Expiration Date: [11]
07-29-2025
Exclude Flag: [12]
D
Product Characteristics
Color(s):
ORANGE (C48331 - SWEDISH ORANGE)
WHITE (C48325)
YELLOW (C48330)
WHITE (C48325)
YELLOW (C48330)
Shape:
CAPSULE (C48336)
Size(s):
19 MM
22 MM
22 MM
Imprint(s):
A733;5MG
A733;10MG
A733;20MG
A733;30MG
Score:
1
Code Structure Chart
Product Details
What is NDC 76431-130?
The NDC code 76431-130 is assigned by the FDA to the product Juxtapid. This pharmaceutical product is labeled by Amryt Pharmaceuticals Dac and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 76431-130-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
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.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- LOMITAPIDE MESYLATE (UNII: X4S83CP54E)
- LOMITAPIDE (UNII: 82KUB0583F) (Active Moiety)
What is the NDC to RxNorm Crosswalk for this product?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
- 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
* Please review the full disclaimer at the bottom of this page.
Patient Education
Lomitapide
Lomitapide is used along with diet changes (restriction of cholesterol and fat intake) and other treatments to reduce the amount of low-density lipoprotein (LDL) cholesterol ('bad cholesterol'), total cholesterol, and other fatty substances in the blood in people that have homozygous familial hypercholesterolemia (HoFH; an inherited condition in which cholesterol cannot be removed from the body normally). Lomitapide should not be used to decrease cholesterol levels in people who do not have HoFH. Lomitapide is in a class of medications called cholesterol-lowering medications. It works by slowing the production of cholesterol in the body to decrease the amount of cholesterol that may build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body. Accumulation of cholesterol and fats along the walls of your arteries (a process known as atherosclerosis) decreases blood flow and, therefore, the oxygen supply to your heart, brain, and other parts of your body. Lowering your blood level of cholesterol and fats may help prevent heart disease, angina (chest pain), strokes, and heart attacks.
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* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
