Prehevbrio
NDC Package 75052-001-10

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 inactivated by the FDA.

Prehevbrio is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. Marketed by Vbi Vaccines (delaware) Inc., this product is identified by NDC 75052-001 and is authorized under FDA application BLA125737.

Identification & Billing

NDC Package Code
75052-001-10
Package Description
10 VIAL, GLASS in 1 CARTON / 1 mL in 1 VIAL, GLASS (75052-001-01)
Product Code
75052-001
11-Digit Billing Format
75052000110
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 2588237 - Hepatitis B (Recombinant) Vaccine 1 ML Injection
  • RxCUI: 2588237 - 1 ML hepatitis B surface antigen (isoform L), recombinant 0.01 MG/ML / hepatitis B surface antigen (isoform M), recombinant 0.01 MG/ML / hepatitis B surface antigen (isoform S), recombinant 0.01 MG/ML Injection
  • RxCUI: 2588240 - PREHEVBRIO Hepatitis B (Recombinant) Vaccine 1 ML Injection
  • RxCUI: 2588240 - 1 ML hepatitis B surface antigen (isoform L), recombinant 0.01 MG/ML / hepatitis B surface antigen (isoform M), recombinant 0.01 MG/ML / hepatitis B surface antigen (isoform S), recombinant 0.01 MG/ML Injection [Prehevbrio]
  • RxCUI: 2588240 - Prehevbrio vaccine 1 ML Injection

Clinical Specifications

Proprietary Name
Prehevbrio
Dosage Form
-
Usage Information
PREHEVBRIO is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. PREHEVBRIO is approved for use in adults 18 years of age and older.

Regulatory & Marketing

Labeler Name
Vbi Vaccines (delaware) Inc.
FDA Application #
BLA125737
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
03-02-2022
Listing Expiration
12-31-2025
Exclude Flag
I
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 75052-001-10 identifies a specific commercial package of 10 vial, glass in 1 carton / 1 ml in 1 vial, glass (75052-001-01) of Prehevbrio, labeled by Vbi Vaccines (delaware) Inc.. 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 Vbi Vaccines (delaware) Inc. on March 02, 2022. The current certification is valid through December 31, 2025.

How is this Vbi Vaccines (delaware) Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 75052000110. 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)
75052-001-10
11-Digit CMS (5-4-2)
75052-0001-10

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