Acthib Kit
NDC 49281-545

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 49281-545?
  4. Acthib Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Patient Education

Product Information

Acthib (haemophilus influenzae type b strain 1482 capsular polysaccharide tetanus toxoid conjugate antigen) is a BLA-approved product labeled by Sanofi Vaccines Us Inc.. This vaccine helps protect young children from Haemophilus influenzae type b (Hib) infection. It is supplied as a kit. This product entry covers the primary NDC 49281-545 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
49281-545
Proprietary Name:
Acthib
Non-Proprietary Name: [1]
Haemophilus Influenzae Type B Strain 1482 Capsular Polysaccharide Tetanus Toxoid Conjugate Antigen
NDC Directory Status:
Vaccine
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Kit - A packaged collection of related material.

Labeler & Regulatory Data

Labeler Name: [5]
Sanofi Vaccines Us Inc.
Labeler Code:
49281
Product Label ID:
8143d01c-4911-40db-95b2-47f3ebea2a7d
FDA Application Number: [6]
BLA103935
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.

Marketing Timeline

Start Marketing Date: [9]
03-30-1993
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 49281-545?

The NDC code 49281-545 is assigned by the FDA to the product Acthib. It is commonly known by its generic name, haemophilus influenzae type b strain 1482 capsular polysaccharide tetanus toxoid conjugate antigen. This pharmaceutical product is labeled by Sanofi Vaccines Us Inc. and is currently categorized as listed product. The medication is a kit. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 49281-545-03. 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 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 the associated UNII Codes?

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

  • HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN (UNII: FLV5I5W26R)
  • HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN (UNII: FLV5I5W26R) (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: 1300466 - Haemophilus b conjugate vaccine (tetanus toxoid conjugate) (Hib generic for ActHIB) 0.5 mL Injection
  • RxCUI: 1300466 - 0.5 ML Haemophilus influenzae type b strain 1482, capsular polysaccharide inactivated tetanus toxoid conjugate vaccine 0.068 MG/ML Injection
  • RxCUI: 1300466 - purified capsular polysaccharide 10 MCG conjugated to inactivated tetanus toxoid 24 MCG per 0.5 ML Injection
  • RxCUI: 1300468 - ActHIB vaccine 0.5 ML Injection
  • RxCUI: 1300468 - 0.5 ML Haemophilus influenzae type b strain 1482, capsular polysaccharide inactivated tetanus toxoid conjugate vaccine 0.068 MG/ML Injection [ActHIB]

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

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 full disclaimer at the bottom of this page.

Product & Regulatory Definitions
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.
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.
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 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".