Livdelzi Capsule
NDC Package 61958-3301-2

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

Livdelzi (seladelpar lysine) capsules is lIVDELZI is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.This indication is approved under accelerated approval based on a reduction of alkaline phosphatase (ALP) [see Clinical Studies (14)]. This formulation utilizes a capsule delivery system. Marketed by Gilead Sciences, Inc, this product is identified by NDC 61958-3301 and is authorized under FDA application NDA217899.

Identification & Billing

NDC Package Code
61958-3301-2
Package Description
30 CAPSULE in 1 BOTTLE
Product Code
61958-3301
11-Digit Billing Format
61958330102
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Livdelzi
Non-Proprietary Name
Seladelpar Lysine
Substance Name
Seladelpar Lysine
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SELADELPAR LYSINE 10 mg/1
Usage Information
LIVDELZI is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.This indication is approved under accelerated approval based on a reduction of alkaline phosphatase (ALP) [see Clinical Studies (14)]. Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Regulatory & Marketing

Labeler Name
Gilead Sciences, Inc
Product Type
Human Prescription Drug
FDA Application #
NDA217899
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-14-2024
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 (61958-3301). Click a package code to view its specific billing and regulatory data.

61958-3301-1
30 CAPSULE in 1 BOTTLE

* 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 61958-3301-2 identifies a specific commercial package of 30 capsule in 1 bottle of Livdelzi, a human prescription drug labeled by Gilead Sciences, Inc. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This capsule is formulated for oral use and contains seladelpar lysine 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 Gilead Sciences, Inc on August 14, 2024. The current certification is valid through December 31, 2027.

How is this Gilead Sciences, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61958330102. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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 (5-4-1)
61958-3301-2
11-Digit CMS (5-4-2)
61958-3301-02

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