Engerix-b Injection, Suspension
NDC Package 58160-821-52

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. Frequently Asked Questions

Package Information

Engerix-b (hepatitis b vaccine (recombinant)) injection is eNGERIX-B® is indicated for immunization against infection caused by all known subtypes of hepatitis B virus. This formulation utilizes a injection, suspension delivery system. Marketed by Glaxosmithkline Biologicals Sa, this product is identified by NDC 58160-821 and is authorized under FDA application BLA103239.

Identification & Billing

NDC Package Code
58160-821-52
Package Description
10 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE (58160-821-43)
Product Code
58160-821
11-Digit Billing Format
58160082152
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1658156 - hepatitis B vaccine (recombinant) adult 20 MCG in 1 ML Injection
  • RxCUI: 1658156 - 1 ML hepatitis B surface antigen vaccine 0.02 MG/ML Injection
  • RxCUI: 1658156 - hepatitis B surface antigen vaccine 20 MCG per 1 ML Injection
  • RxCUI: 1658157 - ENGERIX-B adult 20 MCG in 1 ML Injection
  • RxCUI: 1658157 - 1 ML hepatitis B surface antigen vaccine 0.02 MG/ML Injection [Engerix-B]

Clinical Specifications

Proprietary Name
Engerix-b
Non-Proprietary Name
Hepatitis B Vaccine (recombinant)
Substance Name
Hepatitis B Virus Subtype Adw2 Hbsag Surface Protein Antigen
Dosage Form
Injection, Suspension - A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa.
Administration Route
Intramuscular - Administration within a muscle.
Active Ingredient(s)
HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN 20 ug/mL
Usage Information
ENGERIX-B® is indicated for immunization against infection caused by all known subtypes of hepatitis B virus.

Regulatory & Marketing

Labeler Name
Glaxosmithkline Biologicals Sa
Product Type
Vaccine
FDA Application #
BLA103239
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
03-28-2007
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

90740
Source: AWP
HEPB VACC 3 DOSE IMMUNSUP IM
HCPCS Dosage 40 MCG
Units / Pkg 5

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 (58160-821). Click a package code to view its specific billing and regulatory data.

58160-821-11
10 VIAL in 1 CARTON / 1 mL in 1 VIAL (58160-821-01)

* 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 58160-821-52 identifies a specific commercial package of 10 syringe in 1 carton / 1 ml in 1 syringe (58160-821-43) of Engerix-b, a vaccine label labeled by Glaxosmithkline Biologicals Sa. This injection, suspension is formulated for intramuscular use and contains hepatitis b virus subtype adw2 hbsag surface protein antigen 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 Biologicals Sa on March 28, 2007. The current certification is valid through December 31, 2027.

How is this Glaxosmithkline Biologicals Sa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58160082152. 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)
58160-821-52
11-Digit CMS (5-4-2)
58160-0821-52

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