Ipol Injection, Suspension
NDC Package 49281-860-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Ipol (poliovirus type 1 antigen (formaldehyde inactivated), poliovirus type 2 antigen (formaldehyde inactivated), and poliovirus type 3 antigen (formaldehyde inactivated)) injection is this vaccine is used to prevent a certain virus infection (polio). This formulation utilizes a injection, suspension delivery system. Marketed by Sanofi Vaccines Us Inc., this product is identified by NDC 49281-860 and is authorized under FDA application BLA103930.

Identification & Billing

NDC Package Code
49281-860-10
Package Description
1 VIAL, MULTI-DOSE in 1 PACKAGE / 5 mL in 1 VIAL, MULTI-DOSE (49281-860-78)
Product Code
49281-860
11-Digit Billing Format
49281086010
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • 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]

Clinical Specifications

Proprietary Name
Ipol
Non-Proprietary Name
Poliovirus Type 1 Antigen (formaldehyde Inactivated), Poliovirus Type 2 Antigen (formaldehyde Inactivated), And Poliovirus Type 3 Antigen (formaldehyde Inactivated)
Substance Name
Poliovirus Type 1 Antigen (formaldehyde Inactivated); Poliovirus Type 2 Antigen (formaldehyde Inactivated); Poliovirus Type 3 Antigen (formaldehyde Inactivated)
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
Intramuscular - Administration within a muscle.
Active Ingredient(s)
Pharmacologic Class
Usage Information
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.

Regulatory & Marketing

Labeler Name
Sanofi Vaccines Us Inc.
Product Type
Vaccine
FDA Application #
BLA103930
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
12-21-1990
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 49281-860-10 identifies a specific commercial package of 1 vial, multi-dose in 1 package / 5 ml in 1 vial, multi-dose (49281-860-78) of Ipol, a vaccine label labeled by Sanofi Vaccines Us Inc.. This injection, suspension is formulated for intramuscular use and contains poliovirus type 1 antigen (formaldehyde inactivated); poliovirus type 2 antigen (formaldehyde inactivated); poliovirus type 3 antigen (formaldehyde inactivated) as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Sanofi Vaccines Us Inc. on December 21, 1990. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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.

How is this Sanofi Vaccines Us Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49281086010. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
49281-860-10
11-Digit CMS (5-4-2)
49281-0860-10

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.