Hepcludex Injection, Powder, Lyophilized, For Solution
NDC Package 61958-3104-1

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

Package Information

Hepcludex (bulevirtide) injection is hEPCLUDEX is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis.This indication is approved under accelerated approval based on a decrease in HDV RNA and alanine aminotransferase (ALT) normalization [see Clinical Studies (14)]. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Gilead Sciences, Inc., this product is identified by NDC 61958-3104 and is authorized under FDA application BLA761468.

Identification & Billing

NDC Package Code
61958-3104-1
Package Description
30 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (61958-3104-2)
Product Code
61958-3104
11-Digit Billing Format
61958310401
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Hepcludex
Non-Proprietary Name
Bulevirtide
Substance Name
Bulevirtide Acetate
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
BULEVIRTIDE ACETATE 8.5 mg/1
Usage Information
HEPCLUDEX is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis.This indication is approved under accelerated approval based on a decrease in HDV RNA and alanine aminotransferase (ALT) normalization [see Clinical Studies (14)]. An improvement in disease-related clinical outcomes has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Regulatory & Marketing

Labeler Name
Gilead Sciences, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761468
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
05-22-2026
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.

* 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 61958-3104-1 identifies a specific commercial package of 30 vial, single-dose in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose (61958-3104-2) of Hepcludex, a human prescription drug labeled by Gilead Sciences, Inc.. This injection, powder, lyophilized, for solution is formulated for subcutaneous use and contains bulevirtide acetate 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 May 22, 2026. 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: 61958310401. 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)
61958-3104-1
11-Digit CMS (5-4-2)
61958-3104-01

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