43528-003 NDC - HEPLISAV-B (HEPATITIS B VACCINE (RECOMBINANT) ADJUVANTED)

Drug Information

Product NDC: 43528-003

Proprietary Name: HEPLISAV-B

Non Proprietary Name: Hepatitis B Vaccine (Recombinant) Adjuvanted

Active Ingredient(s):
  • 20 ug/.5mL HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN


Administration Route(s): INTRAMUSCULAR

Dosage Form(s): INJECTION, SOLUTION

Pharmacy Class(es):
  • Inactivated Hepatitis B Virus Vaccine [EPC];
  • Actively Acquired Immunity [PE];
  • Hepatitis B Vaccines [CS];
  • Vaccines;
  • Inactivated [CS]

Labeler Information

Labeler Name: Dynavax Technologies Corporation
Product Type: VACCINE
FDA Application Number: BLA125428
Marketing Category: BLA
Start Marketing Date:1/1/2018

Package Information

No. Package Code Package Description Billing Unit
143528-003-055 SYRINGE in 1 CARTON (43528-003-05) > .5 mL in 1 SYRINGE (43528-003-01)ML

NDC Record

Field Name Field Value Definition
PRODUCT NDC43528-003The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEVACCINEIndicates 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.
PROPRIETARY NAMEHEPLISAV-BThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEHepatitis B Vaccine (Recombinant) AdjuvantedThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTION, SOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEINTRAMUSCULARThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE1/1/2018This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEBLAProduct 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.
APPLICATION NUMBERBLA125428This 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.
LABELER NAMEDynavax Technologies CorporationName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEHEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGENThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH20 
ACTIVE INGRED UNITug/.5mL 
PHARM CLASSESInactivated Hepatitis B Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis B Vaccines [CS],Vaccines, Inactivated [CS] 

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This page was last updated on: 10/4/2019