NDC 63361-245 Vaxelis
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Product Information
Get all the details for National Drug Code (NDC) 63361-245 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.
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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.
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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
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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..
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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.
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Tetanus, Diphtheria, Pertussis (Tdap) Vaccine
Why get vaccinated? Tdap vaccine can prevent tetanus, diphtheria, and pertussis. Diphtheria and pertussis spread from person to person. Tetanus enters the body through cuts or wounds. TETANUS (T) causes painful stiffening of the muscles. Tetanus can lead to serious health problems, including being unable to open the mouth, having trouble swallowing and breathing, or death. DIPHTHERIA (D) can lead to difficulty breathing, heart failure, paralysis, 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.
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[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".
