Lynavoy Tablet, Film Coated
NDC Package 69516-140-60

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

Package Information

Lynavoy (linerixibat) tablets is lYNAVOY is indicated for the treatment of cholestatic pruritus associated with primary biliary cholangitis (PBC) in adult patients.Limitations of UseAvoid use of LYNAVOY in patients with decompensated cirrhosis or those with prior or active hepatic decompensation events (e.g. This formulation utilizes a tablet, film coated delivery system. Marketed by Intercept Pharmaceuticals Inc, this product is identified by NDC 69516-140 and is authorized under FDA application NDA220295.

Identification & Billing

NDC Package Code
69516-140-60
Package Description
60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
69516-140
11-Digit Billing Format
69516014060
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lynavoy
Non-Proprietary Name
Linerixibat
Substance Name
Linerixibat
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)
LINERIXIBAT 40 mg/1
Pharmacologic Class
Usage Information
LYNAVOY is indicated for the treatment of cholestatic pruritus associated with primary biliary cholangitis (PBC) in adult patients.Limitations of UseAvoid use of LYNAVOY in patients with decompensated cirrhosis or those with prior or active hepatic decompensation events (e.g. variceal hemorrhage, ascites, hepatic encephalopathy) [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

Regulatory & Marketing

Labeler Name
Intercept Pharmaceuticals Inc
Product Type
Human Prescription Drug
FDA Application #
NDA220295
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-11-2026
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.

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Frequently Asked Questions

What is the distribution configuration for this product package?

The code 69516-140-60 identifies a specific commercial package of 60 tablet, film coated in 1 bottle, plastic of Lynavoy, a human prescription drug labeled by Intercept Pharmaceuticals Inc. This tablet, film coated is formulated for oral use and contains linerixibat 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 Intercept Pharmaceuticals Inc on June 11, 2026. The current certification is valid through December 31, 2027.

How is this Intercept Pharmaceuticals Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69516014060. 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)
69516-140-60
11-Digit CMS (5-4-2)
69516-0140-60

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