Hepagam B Injection, Solution
NDC Package 49591-052-51

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

Package Information

Hepagam B (human hepatitis b virus immune globulin) injection is a medication used to prevent a certain serious virus infection (hepatitis B) in people who have been exposed to this virus under certain conditions (such as direct contact with blood or body fluids containing this virus). This formulation utilizes a injection, solution delivery system. Marketed by Kamada Ltd., this product is identified by NDC 49591-052 and is authorized under FDA application BLA125035.

Identification & Billing

NDC Package Code
49591-052-51
Package Description
1 VIAL, GLASS in 1 CARTON / 1 mL in 1 VIAL, GLASS (49591-052-11)
Product Code
49591-052
11-Digit Billing Format
49591005251
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1658125 - hepatitis B immune globulin (human) > 312 UNT/ML in 5 ML Injection
  • RxCUI: 1658125 - 5 ML hepatitis B immune globulin 312 UNT/ML Injection
  • RxCUI: 1658147 - hepatitis B immune globulin (human) > 312 UNT/ML in 1 ML Injection
  • RxCUI: 1658147 - 1 ML hepatitis B immune globulin 312 UNT/ML Injection
  • RxCUI: 1658159 - HepaGam B > 312 UNT/ML in 1 ML Injection

Clinical Specifications

Proprietary Name
Hepagam B
Non-Proprietary Name
Human Hepatitis B Virus Immune Globulin
Substance Name
Human Hepatitis B Virus Immune Globulin
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
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN 312 [iU]/mL
Pharmacologic Class
Usage Information
This medication is used to prevent a certain serious virus infection (hepatitis B) in people who have been exposed to this virus under certain conditions (such as direct contact with blood or body fluids containing this virus). Certain brands of this medication may also be given after a liver transplant to prevent return of hepatitis B infection in people with previous infection. Ask your doctor or pharmacist if you have questions about your particular brand. This medication is made from healthy human blood that has high levels of certain defensive substances (antibodies) that help fight hepatitis B.

Regulatory & Marketing

Labeler Name
Kamada Ltd.
Product Type
Plasma Derivative
FDA Application #
BLA125035
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
10-01-2025
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 49591-052-51 identifies a specific commercial package of 1 vial, glass in 1 carton / 1 ml in 1 vial, glass (49591-052-11) of Hepagam B, a plasma derivative labeled by Kamada Ltd.. This injection, solution is formulated for intramuscular; intravenous use and contains human hepatitis b virus immune globulin 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 Kamada Ltd. on October 01, 2025. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to prevent a certain serious virus infection (hepatitis B) in people who have been exposed to this virus under certain conditions (such as direct contact with blood or body fluids containing this virus). Certain brands of this medication may also be given after a liver transplant to prevent return of hepatitis B infection in people with previous infection. Ask your doctor or pharmacist if you have questions about your particular brand. This medication is made from healthy human blood that has high levels of certain defensive substances (antibodies) that help fight hepatitis B.

How is this Kamada Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49591005251. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
49591-052-51
11-Digit CMS (5-4-2)
49591-0052-51

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