Lerochol Injection, Solution
NDC 84685-300

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 84685-300?
  4. Lerochol Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

Lerochol (lerodalcibep-liga) is a BLA-approved product labeled by Lib Therapeutics, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a injection, solution for subcutaneous administration. This product entry covers the primary NDC 84685-300 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
84685-300
Proprietary Name:
Lerochol
Non-Proprietary Name: [1]
Lerodalcibep-liga
Substance Name: [2]
Lerodalcibep
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

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): [4]
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.

Labeler & Regulatory Data

Labeler Name: [5]
Lib Therapeutics, Inc.
Labeler Code:
84685
Product Label ID:
422f8b04-6ce8-4e64-a0a9-0ccc9a4a5860
FDA Application Number: [6]
BLA761427
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.

Marketing Timeline

Start Marketing Date: [9]
12-15-2025
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 84685-300?

The NDC code 84685-300 is assigned by the FDA to the product Lerochol. It is commonly known by its generic name, lerodalcibep-liga. This pharmaceutical product is labeled by Lib Therapeutics, Inc. and is currently categorized as listed product. The medication is a injection, solution administered via subcutaneous route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 84685-300-01. 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?

LEROCHOLTM is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).

What are Active Ingredients of this product?

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.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

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:

* Please review the full disclaimer at the bottom of this page.

Patient Education

Lerodalcibep-liga Injection


Lerodalcibep-liga injection is used to lower cholesterol (fat-like substance that can build up and clog blood vessels causing heart attack or stroke or other health condition). Lerodalcibep-liga is in a class of medications called proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor monoclonal antibodies. It works by stopping the production of cholesterol.
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Cholesterol Medicines


What is cholesterol?

Cholesterol is a waxy, fat-like substance that's found in all the cells in your body. Your body needs some cholesterol to work properly. But if you have too much of it in your blood, it can stick to the walls of your arteries and narrow or even block them. This puts you at risk for coronary artery disease and other heart diseases.

Cholesterol is made by your liver. It travels through the blood on proteins called lipoproteins. One type of lipoprotein, LDL, is sometimes called the "bad" cholesterol. A high LDL level leads to a buildup of cholesterol in your arteries. Another type, HDL, is sometimes called the "good" cholesterol. It carries cholesterol from other parts of your body back to your liver. Then your liver removes the cholesterol from your body.

What are the treatments for high cholesterol?

If you have high cholesterol, lifestyle changes can help you lower your cholesterol levels. But sometimes the lifestyle changes are not enough, and you need to take cholesterol medicines. But you should still continue with the lifestyle changes even though you are taking medicines.

Who needs cholesterol medicines?

Your health care provider may prescribe cholesterol medicines for you if:

  • You have already had a heart attack or stroke, or you have peripheral arterial disease
  • Your LDL (bad) cholesterol level is 190 mg/dL or higher
  • You are 40-75 years old, you have diabetes, and your LDL cholesterol level is 70 mg/dL or higher
  • You are 40-75 years old, you have a high risk of developing heart disease or stroke, and your LDL cholesterol level is 70 mg/dL or higher

What are the different types of cholesterol medicines?

There are several types of cholesterol-lowering drugs available, including:

  • Statins. They reduce the amount of cholesterol made in the liver. They also increase your liver's ability to remove LDL cholesterol that is already in the blood. Statins are the most common medicines used to treat high cholesterol.
  • Bile acid sequestrants. They keep bile acids, which digest fats and oils, from being absorbed into the body. But your body needs bile acids, so your liver will make more of them. It makes them by breaking down LDL cholesterol, so this helps lower your LDL cholesterol. Your provider may prescribe these medicines if you cannot take statins or if statins alone are not lowering your cholesterol enough.
  • Cholesterol absorption inhibitors. They block how cholesterol is absorbed into the body. They are also used if you cannot take statins or if statins alone are not lowering your cholesterol enough.
  • Nicotinic acid (niacin). It is a type of B vitamin. It reduces the amount of fats made by your liver, so it lowers your LDL cholesterol and triglycerides. Niacin also raises HDL cholesterol. Even though you can buy niacin without a prescription, you should talk to your provider before taking it to lower your cholesterol. High doses of niacin can cause serious side effects.
  • PCSK9 inhibitors. These are medicines that you inject under your skin. They block a protein called PCSK9. This helps your liver remove and clear LDL cholesterol from your blood. Your provider may prescribe a PCSK9 inhibitor and a statin if you are at high risk of complications like heart attack or stroke, or if you have familial hypercholesterolemia (FH). FH is an inherited disorder that causes very high levels of cholesterol in the blood.
  • Fibrates. They lower triglycerides in several complex ways, including reducing the amount of triglycerides made by the liver. They may also help increase HDL cholesterol and may lower LDL levels a bit. If you take them with statins, it might increase the risk of side effects.
  • Combination medicines. They include more than one type of cholesterol-lowering medicine. There are also combination medicines that can treat both high blood pressure and cholesterol.

There are also a few other cholesterol medicines (lomitapide and mipomersen) that are only for people who have FH.

How does my health care provider decide which cholesterol medicine I should take?

When deciding which medicine you should take and which dose you need, your provider will consider:

  • Your cholesterol levels.
  • Your risk for heart disease and stroke.
  • Your age.
  • Any other health problems you have.
  • Possible side effects of the medicines. Higher doses are more likely to cause side effects, especially over time.

Medicines can help control your cholesterol, but they don't cure it. You need to keep taking your medicines and get regular cholesterol checks to make sure that your cholesterol levels are in a healthy range.


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* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
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 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".