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  4. NDC Product Code: 49281-562 Quadracel

NDC 49281-562 Quadracel

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 49281-562?
  5. Quadracel Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Patient Education

Product Information

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

Get all the details for National Drug Code (NDC) 49281-562 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
49281-562
Proprietary Name:
Quadracel
Product Type: [3]
Labeler Name: [5]
Sanofi Pasteur Inc.
Labeler Code:
49281
Product Label ID:
99d971ad-54da-420d-b025-eb2dab8c4ec9
FDA Application Number: [6]
BLA125525
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date: [9]
03-24-2015
End Marketing Date: [10]
05-18-2024
Listing Expiration Date: [11]
05-18-2024
Exclude Flag: [12]
D
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - WHITE TO OFF-WHITE)

Code Structure Chart

Product Details

What is NDC 49281-562?

The NDC code 49281-562 is assigned by the FDA to the product Quadracel which is product labeled by Sanofi Pasteur Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 49281-562-10 10 vial, single-use in 1 package / .5 ml in 1 vial, single-use (49281-562-58). 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 Quadracel?

Quadracel™ is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis and poliomyelitis. A single dose of Quadracel is approved for use in children 4 through 6 years of age as a fifth dose in the diphtheria, tetanus, pertussis vaccination (DTaP) series, and as a fourth or fifth dose in the inactivated poliovirus vaccination (IPV) series, in children who have received 4 doses of Pentacel® [Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus and Haemophilus b conjugate (Tetanus Toxoid Conjugate) Vaccine] and/or DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed).

Which are Quadracel UNII Codes?

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

  • CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: IRH51QN26H)
  • CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: IRH51QN26H) (Active Moiety)
  • CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: K3W1N8YP13)
  • CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: K3W1N8YP13) (Active Moiety)
  • BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED) (UNII: F4TN0IPY37)
  • BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED) (UNII: F4TN0IPY37) (Active Moiety)
  • BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 8C367IY4EY)
  • BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 8C367IY4EY) (Active Moiety)
  • BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (UNII: 63GD90PP8X)
  • BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (UNII: 63GD90PP8X) (Active Moiety)
  • BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN (UNII: 1O0600285A)
  • BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN (UNII: 1O0600285A) (Active Moiety)
  • POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 0LVY784C09)
  • POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 0LVY784C09) (Active Moiety)
  • POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 23JE9KDF4R)
  • POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 23JE9KDF4R) (Active Moiety)
  • POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 459ROM8M9M)
  • POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 459ROM8M9M) (Active Moiety)

Which are Quadracel 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:

* Please review the disclaimer below.

Patient Education

Diphtheria, Tetanus, and Pertussis (DTaP) Vaccine


Why get vaccinated? DTaP vaccine can prevent diphtheria, tetanus, and pertussis. Diphtheria and pertussis spread from person to person. Tetanus enters the body through cuts or wounds. DIPHTHERIA (D) can lead to difficulty breathing, heart failure, paralysis, and death. TETANUS (T) causes painful tightening of the muscles. Tetanus can lead to serious health problems, including being unable to open the mouth, having trouble swallowing and breathing, or death. PERTUSSIS (aP), also known as "whooping cough," can cause uncontrollable, violent coughing that makes it hard to breathe, eat, or drink. Pertussis can be extremely serious especially in babies and young children, causing pneumonia, convulsions, brain damage, or death. In teens and adults, it can cause weight loss, loss of bladder control, passing out, and rib fractures from severe coughing.
[Learn More]


Polio Vaccine


Why get vaccinated? Polio vaccine can prevent polio. Polio (or poliomyelitis) is a disabling and lifethreatening disease caused by poliovirus, which can infect a person's spinal cord, leading to paralysis. Most people infected with polio have no symptoms, and many recover without complications. Some people will experience sore throat, fever, tiredness, nausea, headache, or stomach pain. A smaller group of people will develop more serious symptoms that affect the brain and spinal cord: Paresthesia (feeling of pins and needles in the legs), Meningitis (infection of the covering of the spinal cord and/or brain), or Paralysis (can't move parts of the body) or weakness in the arms, legs, or both. Paralysis is the most severe symptom associated with polio because it can lead to permanent disability and death. Improvements in limb paralysis can occur, but in some people new muscle pain and weakness may develop 15 to 40 years later. This is called "post-polio syndrome. Polio has been eliminated from the United States, but it still occurs in other parts of the world. The best way to protect yourself and keep the United States polio-free is to maintain high immunity (protection) in the population against polio through vaccination.
[Learn More]


* Please review the disclaimer below.

Product Footnotes

[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.

[10] 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.

[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, 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".