Heplisav-b
NDC 43528-002

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 43528-002?
  4. Heplisav-b Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Heplisav-b is a BLA-approved product labeled by Dynavax Technologies Corporation. This vaccine is used to help prevent infection from the hepatitis B virus. It is supplied as a product. This product entry covers the primary NDC 43528-002 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
43528-002
Proprietary Name:
Heplisav-b
Product Type: [3]
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Dynavax Technologies Corporation
Labeler Code:
43528
Product Label ID:
d61c7f99-438b-4cac-ae10-997ff4c0fd1f
FDA Application Number: [6]
BLA125428
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.

Marketing Timeline

Start Marketing Date: [9]
01-01-2018
End Marketing Date: [10]
10-17-2019
Listing Expiration Date: [11]
10-17-2019
Exclude Flag: [12]
D

Code Structure Chart

Product Details

What is NDC 43528-002?

The NDC code 43528-002 is assigned by the FDA to the product Heplisav-b. This pharmaceutical product is labeled by Dynavax Technologies Corporation and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 43528-002-05. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

  • HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN (UNII: XL4HLC6JH6)
  • HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN (UNII: XL4HLC6JH6) (Active Moiety)

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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

* Please review the full disclaimer at the bottom of this page.

Patient Education

Hepatitis B Vaccine


Why get vaccinated against hepatitis B? Hepatitis B vaccine can prevent hepatitis B. Hepatitis B is a liver disease that can cause mild illness lasting a few weeks, or it can lead to a serious, lifelong illness. Acute hepatitis B virus infection is a short-term illness that can lead to fever, fatigue, loss of appetite, nausea, vomiting, jaundice (yellow skin or eyes, dark urine, clay-colored bowel movements), and pain in the muscles, joints, and stomach. Chronic hepatitis B virus infection is a long-term illness that occurs when the hepatitis B virus remains in a person's body. Most people who go on to develop chronic hepatitis B do not have symptoms, but it is still very serious and can lead to liver damage (cirrhosis), liver cancer, and death. Chronically infected people can spread hepatitis B virus to others, even if they do not feel or look sick themselves. Hepatitis B is spread when blood, semen, or other body fluid infected with the hepatitis B virus enters the body of a person who is not infected. People can become infected with the virus through: Birth (if a pregnant person has hepatitis B, their baby can become infected) Sharing items such as razors or toothbrushes with an infected person Contact with the blood or open sores of an infected person Sex with an infected partner Sharing needles, syringes, or other drug-injection equipment Exposure to blood from needlesticks or other sharp instruments Most people who are vaccinated with hepatitis B vaccine are immune for life..
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* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What 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.
What 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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".