NDC 76431-105 Juxtapid
Lomitapide Mesylate Capsule Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 76431 - Amryt Pharmaceuticals Dac
- 76431-105 - Juxtapid
Product Characteristics
Product Packages
NDC Code 76431-105-01
Package Description: 28 CAPSULE in 1 BOTTLE
Product Details
What is NDC 76431-105?
What are the uses for Juxtapid?
What are Juxtapid Active Ingredients?
Which are Juxtapid 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 Juxtapid?
- 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
Which are the Pharmacologic Classes for Juxtapid?
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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 disclaimer below.
[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.
[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.
[6] 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.
[8] 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.
[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.
[11] 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.
[12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".