Hiberix Kit
NDC Package 58160-726-15
Package Information
Hiberix (haemophilus b conjugate vaccine (tetanus toxoid conjugate)) kits is this vaccine helps protect young children from Haemophilus influenzae type b (Hib) infection. This formulation utilizes a kit delivery system. Marketed by Glaxosmithkline Biologicals Sa, this product is identified by NDC 58160-726 and is authorized under FDA application BLA125347.
Identification & Billing
- RxCUI: 1300808 - Haemophilus b conjugate vaccine (tetanus toxoid conjugate) (Hib generic for Hiberix) 0.5 mL Injection
- RxCUI: 1300808 - 0.5 ML Haemophilus influenzae type b strain 20752, capsular polysaccharide inactivated tetanus toxoid conjugate vaccine 0.07 MG/ML Injection
- RxCUI: 1300808 - Haemophilus influenzae type b strain 20,752, capsular polysaccharide inactivated tetanus toxoid conjugate vaccine 35 MCG per 0.5 ML Injection
- RxCUI: 1300810 - HIBERIX vaccine 0.5 ML Injection
- RxCUI: 1300810 - 0.5 ML Haemophilus influenzae type b strain 20752, capsular polysaccharide inactivated tetanus toxoid conjugate vaccine 0.07 MG/ML Injection [Hiberix]
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 58160 - Glaxosmithkline Biologicals Sa
- 58160-726 - Hiberix
- 58160-726-15 - 1 KIT in 1 CARTON * .85 mL in 1 SYRINGE (58160-817-02) * .5 mL in 1 VIAL (58160-816-03)
- 58160-726 - Hiberix
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 58160-726-15 identifies a specific commercial package of 1 kit in 1 carton * .85 ml in 1 syringe (58160-817-02) * .5 ml in 1 vial (58160-816-03) of Hiberix, a vaccine label labeled by Glaxosmithkline Biologicals Sa. 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 Glaxosmithkline Biologicals Sa on December 20, 2023. The current certification is valid through December 31, 2026.
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 Glaxosmithkline Biologicals Sa product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 58160072615. 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.
