NDC 43528-002-05 Heplisav-b

Hepatitis B Vaccine (recombinant) Adjuvanted

NDC Package Code 43528-002-05

Field Name Field Value
NDC Code 43528-002-05
Package Description 5 VIAL in 1 CARTON > .5 mL in 1 VIAL (43528-002-01)
Proprietary Name Heplisav-b Additional informationCallout TooltipWhat is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Hepatitis B Vaccine (recombinant) Adjuvanted Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
11-Digit NDC Billing Format 43528000205 Additional informationCallout TooltipNDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
Billing Unit ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Product Type Vaccine Additional informationCallout TooltipWhat kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Labeler Name Dynavax Technologies Corporation
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(s)
  • Intramuscular - Administration within a muscle.
Active Ingredient(s)
  • HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN 20 ug/.5mL
Pharmacological Class(es)
  • Inactivated Hepatitis B Virus Vaccine - [EPC] (Established Pharmacologic Class)
  • Actively Acquired Immunity - [PE] (Physiologic Effect)
  • Hepatitis B Vaccines - [Chemical/Ingredient]
  • Vaccines -
  • Inactivated - [Chemical/Ingredient]
Marketing Category BLA - A product marketed under an approved Biologic License Application. Additional informationCallout TooltipWhat is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number BLA125428 Additional informationCallout TooltipWhat is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Start Marketing Date 01-01-2018 Additional informationCallout TooltipWhat is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

The NDC Code 43528-002-05 is assigned to Heplisav-b, a vaccine lable labeled by Dynavax Technologies Corporation. The product's dosage form is injection, solution and is administered via intramuscular form.


Code Structure
  • 43528 - Dynavax Technologies Corporation
    • 43528-002 - Heplisav-b
      • 43528-002-05 - 5 VIAL in 1 CARTON

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.

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NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 43528-002-05 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
4352800020590739HEPB VACC 2 DOSE ADULT IM1 DOSE0.5515

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