Heplisav-b Injection, Solution
NDC Package 43528-003-05

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

Package Information

Heplisav-b (hepatitis b vaccine (recombinant) adjuvanted) injection is this vaccine is used to help prevent infection from the hepatitis B virus. This formulation utilizes a injection, solution delivery system. Marketed by Dynavax Technologies Corporation, this product is identified by NDC 43528-003 and is authorized under FDA application BLA125428.

Identification & Billing

NDC Package Code
43528-003-05
Package Description
5 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE (43528-003-01)
Product Code
43528-003
11-Digit Billing Format
43528000305
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1994347 - hepatitis B surface antigen vaccine 20 MCG in 0.5 ML Injection
  • RxCUI: 1994347 - 0.5 ML hepatitis B surface antigen vaccine 0.04 MG/ML Injection
  • RxCUI: 1994347 - hepatitis B surface antigen vaccine 0.04 MG/ML per 0.5 ML Injection
  • RxCUI: 1994347 - hepatitis B surface antigen vaccine 20 MCG per 0.5 ML Injection
  • RxCUI: 1994347 - hepatitis B vaccine (recombinant) pediatric/adolescent 20 MCG in 0.5 ML Injection

Clinical Specifications

Proprietary Name
Heplisav-b
Non-Proprietary Name
Hepatitis B Vaccine (recombinant) Adjuvanted
Substance Name
Hepatitis B Virus Subtype Adw Hbsag Surface Protein Antigen
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.
Active Ingredient(s)
HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN 20 ug/.5mL
Pharmacologic Class
Usage Information
This vaccine is used to help prevent infection from the hepatitis B virus. Hepatitis B infection can cause serious problems including liver failure, persistent hepatitis B infection, cirrhosis, and liver cancer. Preventing infection can prevent these problems. Hepatitis B vaccine is a genetically engineered (man-made in the laboratory) piece of the virus. It does not contain live virus, so you cannot get hepatitis from the vaccine. This vaccine works by helping the body produce immunity (through antibody production) that will prevent you from getting infection from hepatitis B virus. Hepatitis B vaccine does not protect you from other virus infections (such as HIV virus which causes AIDS; hepatitis A, hepatitis C or hepatitis E; HPV virus which causes genital warts and other problems). The vaccine is recommended for people of all ages, especially those at an increased risk of getting the infection. Those at an increased risk include health care personnel, laboratory workers who handle blood and patient specimens, police, fire and emergency medical personnel who give first aid treatment, hemophiliacs, dialysis patients, people who live with or spend much time with people with persistent hepatitis B infections, people with multiple sex partners, men who have sex with men, sex workers, injection drug abusers, and people traveling to high-risk areas.

Regulatory & Marketing

Labeler Name
Dynavax Technologies Corporation
Product Type
Vaccine
FDA Application #
BLA125428
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
01-01-2018
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.

90739
Source: AWP
HEPB VACC 2 DOSE ADULT IM
HCPCS Dosage 1 DOSE
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 43528-003-05 identifies a specific commercial package of 5 syringe in 1 carton / .5 ml in 1 syringe (43528-003-01) of Heplisav-b, a vaccine label labeled by Dynavax Technologies Corporation. This injection, solution is formulated for intramuscular use and contains hepatitis b virus subtype adw 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 Dynavax Technologies Corporation on January 01, 2018. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This vaccine is used to help prevent infection from the hepatitis B virus. Hepatitis B infection can cause serious problems including liver failure, persistent hepatitis B infection, cirrhosis, and liver cancer. Preventing infection can prevent these problems. Hepatitis B vaccine is a genetically engineered (man-made in the laboratory) piece of the virus. It does not contain live virus, so you cannot get hepatitis from the vaccine. This vaccine works by helping the body produce immunity (through antibody production) that will prevent you from getting infection from hepatitis B virus. Hepatitis B vaccine does not protect you from other virus infections (such as HIV virus which causes AIDS; hepatitis A, hepatitis C or hepatitis E; HPV virus which causes genital warts and other problems). The vaccine is recommended for people of all ages, especially those at an increased risk of getting the infection. Those at an increased risk include health care personnel, laboratory workers who handle blood and patient specimens, police, fire and emergency medical personnel who give first aid treatment, hemophiliacs, dialysis patients, people who live with or spend much time with people with persistent hepatitis B infections, people with multiple sex partners, men who have sex with men, sex workers, injection drug abusers, and people traveling to high-risk areas.

How is this Dynavax Technologies Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43528000305. 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)
43528-003-05
11-Digit CMS (5-4-2)
43528-0003-05

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