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  4. NDC Product Code: 75052-001 Prehevbrio

NDC 75052-001 Prehevbrio

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

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 75052-001?
  4. Prehevbrio Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

NDC Product Code:
75052-001
Proprietary Name:
Prehevbrio
Non-Proprietary Name: [1]
Hepatitis B Vaccine (recombinant)
Substance Name: [2]
Recombinant Hepatitis B Surface Antigen (isoform L); Recombinant Hepatitis B Surface Antigen (isoform M); Recombinant Hepatitis B Surface Antigen (isoform S)
NDC Directory Status:
Vaccine
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection, Suspension - A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa.
Administration Route(s): [4]
  • Intramuscular - Administration within a muscle.
    • Labeler Name: [5]
    Vbi Vaccines (delaware) Inc.
    Labeler Code:
    75052
    Product Label ID:
    36e9a878-d6c2-4808-9915-294f47b1fe3d
    FDA Application Number: [6]
    BLA125737
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    03-02-2022
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Code Structure Chart

    Product Details

    What is NDC 75052-001?

    The NDC code 75052-001 is assigned by the FDA to the product Prehevbrio which is a vaccine label product labeled by Vbi Vaccines (delaware) Inc.. The generic name of Prehevbrio is hepatitis b vaccine (recombinant). The product's dosage form is injection, suspension and is administered via intramuscular form. The product is distributed in a single package with assigned NDC code 75052-001-10 10 vial, glass in 1 carton / 1 ml in 1 vial, glass (75052-001-01). 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 Prehevbrio?

    PREHEVBRIO is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. PREHEVBRIO is approved for use in adults 18 years of age and older.

    What are Prehevbrio 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 Prehevbrio UNII Codes?

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

    • RECOMBINANT HEPATITIS B SURFACE ANTIGEN (ISOFORM S/SCI-B-VAC) (UNII: 2U8266YW9L)
    • RECOMBINANT HEPATITIS B SURFACE ANTIGEN (ISOFORM S/SCI-B-VAC) (UNII: 2U8266YW9L) (Active Moiety)
    • RECOMBINANT HEPATITIS B SURFACE ANTIGEN (ISOFORM M/SCI-B-VAC) (UNII: SND8HL4KQG)
    • RECOMBINANT HEPATITIS B SURFACE ANTIGEN (ISOFORM M/SCI-B-VAC) (UNII: SND8HL4KQG) (Active Moiety)
    • RECOMBINANT HEPATITIS B SURFACE ANTIGEN (ISOFORM L /SCI-B-VAC) (UNII: C6PFS5DX5Y)
    • RECOMBINANT HEPATITIS B SURFACE ANTIGEN (ISOFORM L /SCI-B-VAC) (UNII: C6PFS5DX5Y) (Active Moiety)

    Which are Prehevbrio 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:

    What is the NDC to RxNorm Crosswalk for Prehevbrio?

    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: 2588237 - Hepatitis B (Recombinant) Vaccine 1 ML Injection
    • RxCUI: 2588237 - 1 ML hepatitis B surface antigen (isoform L), recombinant 0.01 MG/ML / hepatitis B surface antigen (isoform M), recombinant 0.01 MG/ML / hepatitis B surface antigen (isoform S), recombinant 0.01 MG/ML Injection
    • RxCUI: 2588240 - PREHEVBRIO Hepatitis B (Recombinant) Vaccine 1 ML Injection
    • RxCUI: 2588240 - 1 ML hepatitis B surface antigen (isoform L), recombinant 0.01 MG/ML / hepatitis B surface antigen (isoform M), recombinant 0.01 MG/ML / hepatitis B surface antigen (isoform S), recombinant 0.01 MG/ML Injection [Prehevbrio]
    • RxCUI: 2588240 - Prehevbrio vaccine 1 ML Injection

    * Please review the disclaimer below.

    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..
    [Learn More]


    * 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".