Pedvaxhib Injection, Suspension
NDC Package 0006-4897-00

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

Package Information

Pedvaxhib (haemophilus b conjugate vaccine (meningococcal protein conjugate)) injection is this vaccine helps protect young children from Haemophilus influenzae type b (Hib) infection. This formulation utilizes a injection, suspension delivery system. Marketed by Merck Sharp & Dohme Llc, this product is identified by NDC 0006-4897 and is authorized under FDA application BLA103237.

Identification & Billing

NDC Package Code
0006-4897-00
Package Description
10 VIAL, SINGLE-DOSE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-DOSE (0006-4897-01)
Product Code
0006-4897
11-Digit Billing Format
00006489700
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 798447 - Haemophilus b (meningococcal protein conjugate) (Hib) 0.5 mL Injection
  • RxCUI: 798447 - 0.5 ML Haemophilus influenzae b (Ross strain) capsular polysaccharide meningococcal protein conjugate vaccine 0.265 MG/ML Injection
  • RxCUI: 798447 - Haemophilus b conjugate vaccine (meningococcal protein conjugate) 0.5 ML Injection
  • RxCUI: 798451 - PedvaxHIB vaccine 0.5 ML Injection
  • RxCUI: 798451 - 0.5 ML Haemophilus influenzae b (Ross strain) capsular polysaccharide meningococcal protein conjugate vaccine 0.265 MG/ML Injection [PedvaxHIB]

Clinical Specifications

Proprietary Name
Pedvaxhib
Non-Proprietary Name
Haemophilus B Conjugate Vaccine (meningococcal Protein Conjugate)
Substance Name
Haemophilus Influenzae Type B Capsular Polysaccharide Meningococcal Outer Membrane Protein Conjugate Antigen
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)
HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN 7.5 ug/.5mL
Pharmacologic Class
Usage Information
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.

Regulatory & Marketing

Labeler Name
Merck Sharp & Dohme Llc
Product Type
Vaccine
FDA Application #
BLA103237
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
12-20-1989
Listing Expiration
12-31-2026
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 0006-4897-00 identifies a specific commercial package of 10 vial, single-dose in 1 carton / .5 ml in 1 vial, single-dose (0006-4897-01) of Pedvaxhib, a vaccine label labeled by Merck Sharp & Dohme Llc. This injection, suspension is formulated for intramuscular use and contains haemophilus influenzae type b capsular polysaccharide meningococcal outer membrane protein conjugate antigen 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 Merck Sharp & Dohme Llc on December 20, 1989. 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 Merck Sharp & Dohme Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00006489700. 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 (4-4-2)
0006-4897-00
11-Digit CMS (5-4-2)
00006-4897-00

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