NDC Code 0005-0100-02
Package Description: 1 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE (0005-0100-01)
NDC Code 0005-0100-05
Package Description: 5 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE (0005-0100-01)
NDC Code 0005-0100-10
Package Description: 10 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE (0005-0100-01)
Serogroup B Meningococcal Vaccine (MenB)
Why get vaccinated? Meningococcal B vaccine can help protect against meningococcal disease caused by serogroup B. A different meningococcal vaccine is available that can help protect against serogroups A, C, W, and Y. Meningococcal disease can cause meningitis (infection of the lining of the brain and spinal cord) and infections of the blood. Even when it is treated, meningococcal disease kills 10 to 15 infected people out of 100. And of those who survive, about 10 to 20 out of every 100 will suffer disabilities such as hearing loss, brain damage, kidney damage, loss of limbs, nervous system problems, or severe scars from skin grafts. Meningococcal disease is rare and has declined in the United States since the 1990s. However, it is a severe disease with a significant risk of death or lasting disabilities in people who get it. Anyone can get meningococcal disease. Certain people are at increased risk, including: Infants younger than one year old Adolescents and young adults 16 through 23 years old People with certain medical conditions that affect the immune system Microbiologists who routinely work with isolates of N. meningitidis, the bacteria that cause meningococcal disease People at risk because of an outbreak in their community
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 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 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.
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 What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.
 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.
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 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.
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