Hibsago Injection, Solution
NDC Package 0173-0941-39

11-digit billing NDC: 00173094139
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Hibsago (bepirovirsen) injection is hIBSAGO is indicated in combination with nucleos(t)ide analog reverse transcriptase inhibitor (NrtI) therapy for treatment of chronic hepatitis B virus (HBV) infection in adult patients without cirrhosis:•who have been on NrtI therapy for at least 6 months and have suppressed HBV deoxyribonucleic acid (DNA), and•who have HBV surface antigen (HBsAg) levels less than or equal to 3,000 IU/mL as determined by an FDA-authorized test [see Dosage and Administration (2.2)]. This formulation utilizes a injection, solution delivery system. Marketed by Glaxosmithkline Llc, this product is identified by NDC 0173-0941 and is authorized under FDA application NDA221276.

Identification & Billing

NDC Package Code
0173-0941-39
Package Description
2 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE
Product Code
0173-0941
11-Digit Billing Format
00173094139

Clinical Specifications

Proprietary Name
Hibsago
Non-Proprietary Name
Bepirovirsen
Substance Name
Bepirovirsen Sodium
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
BEPIROVIRSEN SODIUM 150 mg/mL
Usage Information
HIBSAGO is indicated in combination with nucleos(t)ide analog reverse transcriptase inhibitor (NrtI) therapy for treatment of chronic hepatitis B virus (HBV) infection in adult patients without cirrhosis:•who have been on NrtI therapy for at least 6 months and have suppressed HBV deoxyribonucleic acid (DNA), and•who have HBV surface antigen (HBsAg) levels less than or equal to 3,000 IU/mL as determined by an FDA-authorized test [see Dosage and Administration (2.2)].

Regulatory & Marketing

Labeler Name
Glaxosmithkline Llc
Product Type
Human Prescription Drug
FDA Application #
NDA221276
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-20-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0173-0941). Click a package code to view its specific billing and regulatory data.

0173-0941-66
2 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE

* 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 0173-0941-39 identifies a specific commercial package of 2 syringe in 1 carton / 1 ml in 1 syringe of Hibsago, a human prescription drug labeled by Glaxosmithkline Llc. This injection, solution is formulated for subcutaneous use and contains bepirovirsen sodium 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 Glaxosmithkline Llc on October 20, 2026. The current certification is valid through December 31, 2027.

How is this Glaxosmithkline Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00173094139. 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 (4-4-2)
0173-0941-39
11-Digit CMS (5-4-2)
00173-0941-39

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