NDC Package 61958-3301-1 Livdelzi

Seladelpar Lysine Capsule Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information
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Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

61958-3301-1

Package Description:

30 CAPSULE in 1 BOTTLE

Product Code:

61958-3301

Proprietary Name:

Livdelzi

Non-Proprietary Name:

Seladelpar Lysine

Substance Name:

Seladelpar Lysine

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).

11-Digit NDC Billing Format:

61958330101

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

30 EA

Product Type:

Human Prescription Drug

Labeler Name:

Gilead Sciences, Inc

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(s):

Oral - Administration to or by way of the mouth.

Active Ingredient(s):

SELADELPAR LYSINE 10 mg/1

Sample Package:

FDA Application Number:

NDA217899

Marketing Category:

NDA - A product marketed under an approved New Drug Application.

Start Marketing Date:

08-14-2024

Listing Expiration Date:

12-31-2026

Exclude Flag:

Code Structure:

61958 - Gilead Sciences, Inc
- 61958-3301 - Livdelzi
  - 61958-3301-1 - 30 CAPSULE in 1 BOTTLE

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
61958-3301-2	30 CAPSULE in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 61958-3301-1?

The NDC Packaged Code 61958-3301-1 is assigned to a package of 30 capsule in 1 bottle of Livdelzi, a human prescription drug labeled by Gilead Sciences, Inc. The product's dosage form is capsule and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package.

Is NDC 61958-3301 included in the NDC Directory?

Yes, Livdelzi with product code 61958-3301 is active and included in the NDC Directory. The product was first marketed by Gilead Sciences, Inc on August 14, 2024 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 61958-3301-1?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 30.

What is the 11-digit format for NDC 61958-3301-1?

The 11-digit format is 61958330101. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-4-1	61958-3301-1	5-4-2	61958-3301-01

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