Pentacel
NDC Package 49281-510-05

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

Package Information

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

Pentacel is a medication a combination of vaccines against diphtheria, tetanus (lockjaw), pertussis (whooping cough), polio, and Haemophilus influenzae B infection. Marketed by Sanofi Pasteur Inc., this product is identified by NDC 49281-510 and is authorized under FDA application BLA125145.

Identification & Billing

NDC Package Code
49281-510-05
Package Description
1 KIT in 1 PACKAGE * .5 mL in 1 VIAL, SINGLE-DOSE (49281-560-05) * .5 mL in 1 VIAL, SINGLE-DOSE (49281-548-58)
Product Code
49281-510
11-Digit Billing Format
49281051005
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.

Clinical Specifications

Proprietary Name
Pentacel
Dosage Form
-
Usage Information
This medication is a combination of vaccines against diphtheria, tetanus (lockjaw), pertussis (whooping cough), polio, and Haemophilus influenzae B infection. Vaccination is the best way to protect against these life-threatening infections. Vaccines work by causing the body to produce its own protection (antibodies). This combination of vaccines is usually used in infants and children who are between 6 weeks and 4 years old.

Regulatory & Marketing

Labeler Name
Sanofi Pasteur Inc.
FDA Application #
BLA125145
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
06-20-2008
End Marketing Date
10-02-2022
Listing Expiration
10-02-2022
Exclude Flag
D
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 49281-510-05 identifies a specific commercial package of 1 kit in 1 package * .5 ml in 1 vial, single-dose (49281-560-05) * .5 ml in 1 vial, single-dose (49281-548-58) of Pentacel, labeled by Sanofi Pasteur Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Sanofi Pasteur Inc. on June 20, 2008. The current certification is valid through October 02, 2022.

What are the primary indications for this medication?

This medication is a combination of vaccines against diphtheria, tetanus (lockjaw), pertussis (whooping cough), polio, and Haemophilus influenzae B infection. Vaccination is the best way to protect against these life-threatening infections. Vaccines work by causing the body to produce its own protection (antibodies). This combination of vaccines is usually used in infants and children who are between 6 weeks and 4 years old.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49281051005. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
49281-510-05
11-Digit CMS (5-4-2)
49281-0510-05

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