Heplisav-b Injection, Solution
NDC Package 43528-003-05
Package Information
Heplisav-b (hepatitis b vaccine (recombinant) adjuvanted) injection is hEPLISAV-B is indicated for prevention of infection caused by all known subtypes of 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
- 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
Regulatory & Marketing
Hierarchy Structure
- 43528 - Dynavax Technologies Corporation
- 43528-003 - Heplisav-b
- 43528-003-05 - 5 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE (43528-003-01)
- 43528-003 - Heplisav-b
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.
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 product is billed per "ML" milliliter and contains an estimated amount of 2.5 billable units per package. 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.
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.. There are 2.5 total billable units per package. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
