Livmarli Solution
NDC Package 79378-110-01

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

Package Information

Livmarli (maralixibat chloride) solution is lIVMARLI is indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 1 year of age and older. This formulation utilizes a solution delivery system. Marketed by Mirum Pharmaceuticals Inc., this product is identified by NDC 79378-110 and is authorized under FDA application NDA214662.

Identification & Billing

NDC Package Code
79378-110-01
Package Description
1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE
Product Code
79378-110
11-Digit Billing Format
79378011001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Livmarli
Non-Proprietary Name
Maralixibat Chloride
Substance Name
Maralixibat Chloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
MARALIXIBAT CHLORIDE 9.5 mg/mL
Pharmacologic Class
Usage Information
LIVMARLI is indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 1 year of age and older.

Regulatory & Marketing

Labeler Name
Mirum Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA214662
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-29-2021
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 79378-110-01 identifies a specific commercial package of 1 bottle in 1 carton / 30 ml in 1 bottle of Livmarli, a human prescription drug labeled by Mirum Pharmaceuticals Inc.. This solution is formulated for oral use and contains maralixibat chloride 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 Mirum Pharmaceuticals Inc. on September 29, 2021. The current certification is valid through December 31, 2026.

How is this Mirum Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 79378011001. 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)
79378-110-01
11-Digit CMS (5-4-2)
79378-0110-01

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