Hepagam B
NDC Package 70257-052-51

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Hepagam B 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). Marketed by Saol Therapeutics, this product is identified by NDC 70257-052 and is authorized under FDA application BLA125035.

Identification & Billing

NDC Package Code
70257-052-51
Package Description
1 VIAL, GLASS in 1 CARTON / 1 mL in 1 VIAL, GLASS (70257-052-11)
Product Code
70257-052
11-Digit Billing Format
70257005251
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Hepagam B
Dosage Form
-
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
Saol Therapeutics
FDA Application #
BLA125035
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
01-03-2019
End Marketing Date
09-30-2025
Listing Expiration
09-30-2025
Exclude Flag
D
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 70257-052-51 identifies a specific commercial package of 1 vial, glass in 1 carton / 1 ml in 1 vial, glass (70257-052-11) of Hepagam B, labeled by Saol Therapeutics. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Saol Therapeutics on January 03, 2019. The current certification is valid through September 30, 2025.

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 Saol Therapeutics product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70257005251. 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)
70257-052-51
11-Digit CMS (5-4-2)
70257-0052-51

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