Ctexli Tablet, Film Coated
NDC Package 79378-310-90

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

Package Information

Ctexli (chenodiol) tablets is chenodiol is used to dissolve certain types of gallstones (non-calcified). This formulation utilizes a tablet, film coated delivery system. Marketed by Mirum Pharmaceuticals Inc., this product is identified by NDC 79378-310 and is authorized under FDA application NDA219488.

Identification & Billing

NDC Package Code
79378-310-90
Package Description
100 TABLET, FILM COATED in 1 BOTTLE
Product Code
79378-310
11-Digit Billing Format
79378031090
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ctexli
Non-Proprietary Name
Chenodiol
Substance Name
Chenodiol
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)
CHENODIOL 250 mg/1
Pharmacologic Class
Usage Information
Chenodiol is used to dissolve certain types of gallstones (non-calcified). Chenodiol is a bile acid. Chenodiol may be tried before surgery in patients that are at high risk of complications from gallstone surgery. If the gallstones do not dissolve, emergency surgery may still be needed.

Regulatory & Marketing

Labeler Name
Mirum Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA219488
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-04-2025
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 79378-310-90 identifies a specific commercial package of 100 tablet, film coated in 1 bottle of Ctexli, a human prescription drug labeled by Mirum Pharmaceuticals Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. This tablet, film coated is formulated for oral use and contains chenodiol 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 April 04, 2025. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Chenodiol is used to dissolve certain types of gallstones (non-calcified). Chenodiol is a bile acid. Chenodiol may be tried before surgery in patients that are at high risk of complications from gallstone surgery. If the gallstones do not dissolve, emergency surgery may still be needed.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 79378031090. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. 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)
79378-310-90
11-Digit CMS (5-4-2)
79378-0310-90

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