Ipol Injection, Suspension
NDC 49281-860

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 49281-860?
  4. Ipol Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes
  10. Patient Education

Product Information

Ipol (poliovirus type 1 antigen (formaldehyde inactivated), poliovirus type 2 antigen (formaldehyde inactivated), and poliovirus type 3 antigen (formaldehyde inactivated)) is a BLA-approved product labeled by Sanofi Pasteur Inc.. This vaccine is used to prevent a certain virus infection (polio). It is supplied as a injection, suspension for intramuscular administration. This product entry covers the primary NDC 49281-860 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
49281-860
Proprietary Name:
Ipol
Non-Proprietary Name: [1]
Poliovirus Type 1 Antigen (formaldehyde Inactivated), Poliovirus Type 2 Antigen (formaldehyde Inactivated), And Poliovirus Type 3 Antigen (formaldehyde Inactivated)
Substance Name: [2]
Poliovirus Type 1 Antigen (formaldehyde Inactivated); Poliovirus Type 2 Antigen (formaldehyde Inactivated); Poliovirus Type 3 Antigen (formaldehyde Inactivated)
NDC Directory Status:
Vaccine
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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Clinical Specifications

Dosage Form:
Injection, Suspension - A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa.
Administration Route(s): [4]
Intramuscular - Administration within a muscle.

Labeler & Regulatory Data

Labeler Name: [5]
Sanofi Pasteur Inc.
Labeler Code:
49281
Product Label ID:
34a647f5-8728-451b-b918-94c8acd15974
FDA Application Number: [6]
BLA103930
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.

Marketing Timeline

Start Marketing Date: [9]
12-21-1990
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 49281-860?

The NDC code 49281-860 is assigned by the FDA to the product Ipol. It is commonly known by its generic name, poliovirus type 1 antigen (formaldehyde inactivated), poliovirus type 2 antigen (formaldehyde inactivated), and poliovirus type 3 antigen (formaldehyde inactivated). This pharmaceutical product is labeled by Sanofi Pasteur Inc. and is currently categorized as listed product. The medication is a injection, suspension administered via intramuscular route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 49281-860-10. 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 is used to prevent a certain virus infection (polio). Polio is a virus that affects mainly young children. It is usually spread by person-to-person contact. It can also be spread by eating/drinking contaminated food or water. Most people who get infected with polio have mild or no symptoms. However, some infections can be very serious and can cause inability to move (paralysis) in part of the body, such as the arms, legs, or breathing muscles. There is no cure for polio infection, but it can be prevented by vaccination. This vaccine works by increasing the body's natural defense (immunity) against the polio virus. Polio vaccine is usually given to infants and children as part of routine immunization. It may also be given to adults who haven't been immunized or who may be at increased risk for polio infection, for example by travel to countries where polio is common. Vaccines may not fully protect everyone who receives them.

What are Active Ingredients of this product?

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.

Which are the associated UNII Codes?

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

  • 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 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: 763103 - poliovirus vaccine, inactivated (IPV) Injectable Suspension
  • RxCUI: 763103 - poliovirus vaccine inactivated, type 1 (Mahoney) 80 UNT/ML / poliovirus vaccine inactivated, type 2 (MEF-1) 16 UNT/ML / poliovirus vaccine inactivated, type 3 (Saukett) 64 UNT/ML Injectable Suspension
  • RxCUI: 763103 - poliovirus vaccine inactivated, type 1 (Mahoney) 40 UNT/ML / poliovirus vaccine inactivated, type 2 (MEF-1) 8 UNT/ML / poliovirus vaccine inactivated, type 3 (Saukett) 32 UNT/ML per 0.5 ML Injectable Suspension
  • RxCUI: 763106 - IPOL vaccine Injectable Suspension
  • RxCUI: 763106 - poliovirus vaccine inactivated, type 1 (Mahoney) 80 UNT/ML / poliovirus vaccine inactivated, type 2 (MEF-1) 16 UNT/ML / poliovirus vaccine inactivated, type 3 (Saukett) 64 UNT/ML Injectable Suspension [Ipol]

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Patient Education

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]


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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 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.
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 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.
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".