Pentacel Kit
NDC Package 49281-511-05
Package Information
Pentacel (diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus and haemophilus b conjugate (tetanus toxoid conjugate) vaccine) kits is a medication a combination of vaccines against diphtheria, tetanus (lockjaw), pertussis (whooping cough), polio, and Haemophilus influenzae B infection. This formulation utilizes a kit delivery system. Marketed by Sanofi Vaccines Us Inc., this product is identified by NDC 49281-511 and is authorized under FDA application BLA125145.
Identification & Billing
- RxCUI: 1300466 - Haemophilus b conjugate vaccine (tetanus toxoid conjugate) (Hib generic for ActHIB) 0.5 mL Injection
- RxCUI: 1300466 - 0.5 ML Haemophilus influenzae type b strain 1482, capsular polysaccharide inactivated tetanus toxoid conjugate vaccine 0.068 MG/ML Injection
- RxCUI: 1300466 - purified capsular polysaccharide 10 MCG conjugated to inactivated tetanus toxoid 24 MCG per 0.5 ML Injection
- RxCUI: 1300468 - ActHIB vaccine 0.5 ML Injection
- RxCUI: 1300468 - 0.5 ML Haemophilus influenzae type b strain 1482, capsular polysaccharide inactivated tetanus toxoid conjugate vaccine 0.068 MG/ML Injection [ActHIB]
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 49281 - Sanofi Vaccines Us Inc.
- 49281-511 - Pentacel
- 49281-511-05 - 1 KIT in 1 PACKAGE * .5 mL in 1 VIAL, SINGLE-DOSE (49281-561-01) * .5 mL in 1 VIAL, SINGLE-DOSE (49281-544-58)
- 49281-511 - Pentacel
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 49281-511-05 identifies a specific commercial package of 1 kit in 1 package * .5 ml in 1 vial, single-dose (49281-561-01) * .5 ml in 1 vial, single-dose (49281-544-58) of Pentacel, a vaccine label labeled by Sanofi Vaccines Us Inc.. This kit is formulated for use and contains 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 June 20, 2008. The current certification is valid through December 31, 2027.
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 Vaccines Us Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 49281051105. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
