Acthib Kit
NDC Package 49281-545-03
Package Information
Acthib (haemophilus influenzae type b strain 1482 capsular polysaccharide tetanus toxoid conjugate antigen) kits is this vaccine helps protect young children from Haemophilus influenzae type b (Hib) infection. This formulation utilizes a kit delivery system. Marketed by Sanofi Vaccines Us Inc., this product is identified by NDC 49281-545 and is authorized under FDA application BLA103935.
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.
- 49281-545 - Acthib
- 49281-545-03 - 1 KIT in 1 CARTON * .6 mL in 1 VIAL, SINGLE-DOSE (49281-546-58) * .5 mL in 1 VIAL, SINGLE-DOSE (49281-547-58)
- 49281-545 - Acthib
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 49281-545-03 identifies a specific commercial package of 1 kit in 1 carton * .6 ml in 1 vial, single-dose (49281-546-58) * .5 ml in 1 vial, single-dose (49281-547-58) of Acthib, 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 March 30, 1993. The current certification is valid through December 31, 2027.
What are the primary indications for this medication?
This vaccine helps protect young children from Haemophilus influenzae type b (Hib) infection. Hib is a bacterial infection that can cause serious illness, including brain infection (meningitis). Children younger than age 5 are at highest risk for infection. Vaccination is the best way to protect against this life-threatening disease. Vaccines work by causing the body to produce its own protection (antibodies). This vaccine is not usually used in children over the age of 4 or in adults.
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: 49281054503. 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.
