Vaxelis Injection, Suspension
NDC Package 63361-243-15

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

Package Information

Vaxelis (diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, haemophilus b conjugate and hepatitis b vaccine) injection is vAXELIS™ is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae (H. This formulation utilizes a injection, suspension delivery system. Marketed by Msp Vaccine Company, this product is identified by NDC 63361-243 and is authorized under FDA application BLA125563.

Identification & Billing

NDC Package Code
63361-243-15
Package Description
10 SYRINGE in 1 PACKAGE / .5 mL in 1 SYRINGE (63361-243-88)
Product Code
63361-243
11-Digit Billing Format
63361024315
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 2468237 - DTap-IPV-Hib-HepB (generic for Vaxelis) 0.5 ML Prefilled Syringe
  • RxCUI: 2468237 - 0.5 ML Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 0.04 MG/ML / Bordetella pertussis fimbriae 2/3 vaccine, inactivated 0.01 MG/ML / Bordetella pertussis pertactin vaccine, inactivated 0.006 MG/ML / Bordetella pertussis toxoid vaccine, inactivated 0.04 MG/ML / diphtheria toxoid vaccine, inactivated 30 UNT/ML / Haemophilus influenzae b (Ross strain) capsular polysaccharide meningococcal protein conjugate vaccine 0.006 MG/ML / hepatitis B surface antigen vaccine 0.02 MG/ML / poliovirus vaccine inactivated, type 1 (Mahoney) 58 UNT/ML / poliovirus vaccine inactivated, type 2 (MEF-1) 14 UNT/ML / poliovirus vaccine inactivated, type 3 (Saukett) 52 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML Prefilled Syringe
  • RxCUI: 2468237 - DTap-IPV-Hib-HepB 0.5 ML Prefilled Syringe
  • RxCUI: 2468239 - Vaxelis 0.5 ML Prefilled Syringe
  • RxCUI: 2468239 - 0.5 ML Bordetella pertussis filamentous hemagglutinin vaccine, inactivated 0.04 MG/ML / Bordetella pertussis fimbriae 2/3 vaccine, inactivated 0.01 MG/ML / Bordetella pertussis pertactin vaccine, inactivated 0.006 MG/ML / Bordetella pertussis toxoid vaccine, inactivated 0.04 MG/ML / diphtheria toxoid vaccine, inactivated 30 UNT/ML / Haemophilus influenzae b (Ross strain) capsular polysaccharide meningococcal protein conjugate vaccine 0.006 MG/ML / hepatitis B surface antigen vaccine 0.02 MG/ML / poliovirus vaccine inactivated, type 1 (Mahoney) 58 UNT/ML / poliovirus vaccine inactivated, type 2 (MEF-1) 14 UNT/ML / poliovirus vaccine inactivated, type 3 (Saukett) 52 UNT/ML / tetanus toxoid vaccine, inactivated 10 UNT/ML Prefilled Syringe [Vaxelis]

Clinical Specifications

Proprietary Name
Vaxelis
Non-Proprietary Name
Diphtheria And Tetanus Toxoids And Acellular Pertussis, Inactivated Poliovirus, Haemophilus B Conjugate And Hepatitis B Vaccine
Substance Name
Bordetella Pertussis Filamentous Hemagglutinin Antigen (formaldehyde Inactivated); Bordetella Pertussis Fimbriae 2/3 Antigen; Bordetella Pertussis Pertactin Antigen; Bordetella Pertussis Toxoid Antigen (glutaraldehyde Inactivated); Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated); Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated); Haemophilus Influenzae Type B Capsular Polysaccharide Meningococcal Outer Membrane Protein Conjugate Antigen; Hepatitis B Virus Subtype Adw Hbsag Surface Protein Antigen; Poliovirus Type 1 Antigen (formaldehyde Inactivated); Poliovirus Type 2 Antigen (formaldehyde Inactivated); Poliovirus Type 3 Antigen (formaldehyde Inactivated)
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)
Pharmacologic Class
Usage Information
VAXELIS™ is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae (H. influenzae) type b. VAXELIS is approved for use as a 3-dose series in children 6 weeks through 4 years of age (prior to the 5th birthday).

Regulatory & Marketing

Labeler Name
Msp Vaccine Company
Product Type
Vaccine
FDA Application #
BLA125563
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
12-21-2018
Listing Expiration
12-31-2027
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 63361-243-15 identifies a specific commercial package of 10 syringe in 1 package / .5 ml in 1 syringe (63361-243-88) of Vaxelis, a vaccine label labeled by Msp Vaccine Company. This injection, suspension is formulated for intramuscular use and contains bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated); bordetella pertussis fimbriae 2/3 antigen; bordetella pertussis pertactin antigen; bordetella pertussis toxoid antigen (glutaraldehyde inactivated); clostridium tetani toxoid antigen (formaldehyde inactivated); corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated); haemophilus influenzae type b capsular polysaccharide meningococcal outer membrane protein conjugate antigen; hepatitis b virus subtype adw hbsag surface protein antigen; poliovirus type 1 antigen (formaldehyde inactivated); poliovirus type 2 antigen (formaldehyde inactivated); poliovirus type 3 antigen (formaldehyde inactivated) 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 Msp Vaccine Company on December 21, 2018. The current certification is valid through December 31, 2027.

How is this Msp Vaccine Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63361024315. 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 (5-3-2)
63361-243-15
11-Digit CMS (5-4-2)
63361-0243-15

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