Nexletol Tablet, Film Coated
NDC Package 72426-118-99

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

Package Information

Nexletol (bempedoic acid) tablets is nEXLETOL is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C. This formulation utilizes a tablet, film coated delivery system. Marketed by Esperion Therapeutics, Inc., this product is identified by NDC 72426-118 and is authorized under FDA application NDA211616.

Identification & Billing

NDC Package Code
72426-118-99
Package Description
7 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
72426-118
11-Digit Billing Format
72426011899
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nexletol
Non-Proprietary Name
Bempedoic Acid
Substance Name
Bempedoic Acid
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
BEMPEDOIC ACID 180 mg/1
Pharmacologic Class
Usage Information
NEXLETOL is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C.

Regulatory & Marketing

Labeler Name
Esperion Therapeutics, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA211616
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-06-2020
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (72426-118). Click a package code to view its specific billing and regulatory data.

72426-118-03
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

* 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 72426-118-99 identifies a specific commercial package of 7 tablet, film coated in 1 blister pack of Nexletol, a human prescription drug labeled by Esperion Therapeutics, Inc.. This tablet, film coated is formulated for oral use and contains bempedoic acid 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 Esperion Therapeutics, Inc. on March 06, 2020. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72426011899. 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)
72426-118-99
11-Digit CMS (5-4-2)
72426-0118-99

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