Lerochol Injection, Solution
NDC Package 84685-300-01

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

Package Information

Lerochol (lerodalcibep-liga) injection is 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). This formulation utilizes a injection, solution delivery system. Marketed by Lib Therapeutics, Inc., this product is identified by NDC 84685-300 and is authorized under FDA application BLA761427.

Identification & Billing

NDC Package Code
84685-300-01
Package Description
1 SYRINGE in 1 CARTON / 1.2 mL in 1 SYRINGE
Product Code
84685-300
11-Digit Billing Format
84685030001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lerochol
Non-Proprietary Name
Lerodalcibep-liga
Substance Name
Lerodalcibep
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
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
LERODALCIBEP 300 mg/1.2mL
Usage Information
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).

Regulatory & Marketing

Labeler Name
Lib Therapeutics, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761427
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
12-15-2025
Listing Expiration
12-31-2026
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 84685-300-01 identifies a specific commercial package of 1 syringe in 1 carton / 1.2 ml in 1 syringe of Lerochol, a human prescription drug labeled by Lib Therapeutics, Inc.. This injection, solution is formulated for subcutaneous use and contains lerodalcibep 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 Lib Therapeutics, Inc. on December 15, 2025. The current certification is valid through December 31, 2026.

How is this Lib Therapeutics, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84685030001. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
84685-300-01
11-Digit CMS (5-4-2)
84685-0300-01

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