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NDC 83703-048 Heplisav-b

Hepatitis B Vaccine (recombinant) Adjuvanted Injection, Solution Intramuscular - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 83703-048?
  4. Heplisav-b Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

NDC Product Code:
83703-048
Proprietary Name:
Heplisav-b
Non-Proprietary Name: [1]
Hepatitis B Vaccine (recombinant) Adjuvanted
Substance Name: [2]
Hepatitis B Virus Subtype Adw Hbsag Surface Protein Antigen
NDC Directory Status:
Vaccine
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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): [4]
  • Intramuscular - Administration within a muscle.
    • Labeler Name: [5]
    Bamboo Us Bidco Llc
    Labeler Code:
    83703
    Product Label ID:
    1a8b8271-208d-ecde-e063-6294a90a54c6
    FDA Application Number: [6]
    BLA125428
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    01-01-2018
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Code Structure Chart

    Product Details

    What is NDC 83703-048?

    The NDC code 83703-048 is assigned by the FDA to the product Heplisav-b which is a vaccine label product labeled by Bamboo Us Bidco Llc. The generic name of Heplisav-b is hepatitis b vaccine (recombinant) adjuvanted. The product's dosage form is injection, solution and is administered via intramuscular form. The product is distributed in a single package with assigned NDC code 83703-048-05 5 syringe in 1 carton / .5 ml in 1 syringe (83703-048-01). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Heplisav-b?

    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.

    What are Heplisav-b Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are Heplisav-b 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 Heplisav-b Inactive Ingredients 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:

    Which are the Pharmacologic Classes for Heplisav-b?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Product Footnotes

    [1] What 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.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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.

    [12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".