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NDC 58160-818 Hiberix

Haemophilus B Conjugate Vaccine (tetanus Toxoid Conjugate) Kit - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 58160-818?
  4. Hiberix Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Patient Education

Product Information

NDC Product Code:
58160-818
Proprietary Name:
Hiberix
Non-Proprietary Name: [1]
Haemophilus B Conjugate Vaccine (tetanus Toxoid Conjugate)
NDC Directory Status:
Vaccine
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Glaxosmithkline Biologicals Sa
Labeler Code:
58160
Product Label ID:
745ff8df-1618-4b76-9aa1-6f42752c0dda
FDA Application Number: [6]
BLA125347
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date: [9]
12-21-2015
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
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Product Details

What is NDC 58160-818?

The NDC code 58160-818 is assigned by the FDA to the product Hiberix which is a vaccine label product labeled by Glaxosmithkline Biologicals Sa. The generic name of Hiberix is haemophilus b conjugate vaccine (tetanus toxoid conjugate). The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 58160-818-11 1 kit in 1 carton * 10 vial in 1 carton (58160-816-05) / .5 ml in 1 vial (58160-816-01) * 10 vial in 1 package (58160-817-05) / .85 ml in 1 vial (58160-817-01). 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 Hiberix?

This vaccine helps protect young children from Haemophilus influenzae type b (Hib) infection. Hib is a bacterial infection that can cause serious illness, including brain infection (meningitis). Children younger than age 5 are at highest risk for infection. Vaccination is the best way to protect against this life-threatening disease. Vaccines work by causing the body to produce its own protection (antibodies). This vaccine is not usually used in children over the age of 4 or in adults.

Which are Hiberix UNII Codes?

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

  • HAEMOPHILUS INFLUENZAE TYPE B STRAIN 20752 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN (UNII: C9R35M8XV6)
  • HAEMOPHILUS INFLUENZAE TYPE B STRAIN 20752 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN (UNII: C9R35M8XV6) (Active Moiety)

Which are Hiberix 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 Hiberix?

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: 1300808 - Haemophilus b conjugate vaccine (tetanus toxoid conjugate) (Hib generic for Hiberix) 0.5 mL Injection
  • RxCUI: 1300808 - 0.5 ML Haemophilus influenzae type b strain 20752, capsular polysaccharide inactivated tetanus toxoid conjugate vaccine 0.07 MG/ML Injection
  • RxCUI: 1300808 - Haemophilus influenzae type b strain 20,752, capsular polysaccharide inactivated tetanus toxoid conjugate vaccine 35 MCG per 0.5 ML Injection
  • RxCUI: 1300810 - HIBERIX vaccine 0.5 ML Injection
  • RxCUI: 1300810 - 0.5 ML Haemophilus influenzae type b strain 20752, capsular polysaccharide inactivated tetanus toxoid conjugate vaccine 0.07 MG/ML Injection [Hiberix]

* Please review the disclaimer below.

Patient Education

Haemophilus influenzae type b (Hib) Vaccine


Why get vaccinated? Hib vaccine can prevent Haemophilus influenzae type b (Hib) disease. Haemophilus influenzae type b can cause many different kinds of infections. These infections usually affect children under 5 years of age but can also affect adults with certain medical conditions. Hib bacteria can cause mild illness, such as ear infections or bronchitis, or they can cause severe illness, such as infections of the blood. Severe Hib infection, also called "invasive Hib disease," requires treatment in a hospital and can sometimes result in death. Before Hib vaccine, Hib disease was the leading cause of bacterial meningitis among children under 5 years old in the United States. Meningitis is an infection of the lining of the brain and spinal cord. It can lead to brain damage and deafness. Hib disease can also cause: pneumonia severe swelling in the throat, making it hard to breathe infections of the blood, joints, bones, and covering of the heart death
[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.

[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.

[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".