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  5. NDC Package Code: 63361-243-15 Vaxelis

NDC Package 63361-243-15 Vaxelis

Diphtheria And Tetanus Toxoids And Acellular Pertussis,Inactivated Poliovirus,Haemophilus - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

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
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)
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).
11-Digit NDC Billing Format:
63361024315
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 2109615 - DTap-IPV-Hib-HepB (generic for Vaxelis) 0.5 ML Injection
  • RxCUI: 2109615 - 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 Injection
  • RxCUI: 2109615 - DTap-IPV-Hib-HepB 0.5 ML Injection
  • RxCUI: 2109620 - Vaxelis 0.5 ML Injection
  • RxCUI: 2109620 - 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 Injection [Vaxelis]
    • Product Type:
    Vaccine
    Labeler Name:
    Msp Vaccine Company
    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(s):
  • Intramuscular - Administration within a muscle.
    • Active Ingredient(s):
  • BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) 20 ug/.5mL
  • BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN 5 ug/.5mL
  • BORDETELLA PERTUSSIS PERTACTIN ANTIGEN 3 ug/.5mL
  • BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED) 20 ug/.5mL
  • CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 5 [Lf]/.5mL
  • CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 15 [Lf]/.5mL
  • HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN 3 ug/.5mL
  • HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN 10 ug/.5mL
  • POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED) 29 [D'ag'U]/.5mL
  • POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED) 7 [D'ag'U]/.5mL
  • POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) 26 [D'ag'U]/.5mL
    • Pharmacologic Class(es):
  • Actively Acquired Immunity - [PE] (Physiologic Effect)
  • Actively Acquired Immunity - [PE] (Physiologic Effect)
  • Diphtheria Toxoid - [CS]
  • Haemophilus Vaccines - [CS]
  • Hepatitis B Vaccines - [CS]
  • Inactivated Bordetella Pertussis Vaccine - [EPC] (Established Pharmacologic Class)
  • Inactivated Clostridium Tetani Vaccine - [EPC] (Established Pharmacologic Class)
  • Inactivated Corynebacterium Diphtheriae Vaccine - [EPC] (Established Pharmacologic Class)
  • Inactivated Haemophilus Influenzae B Vaccine - [EPC] (Established Pharmacologic Class)
  • Inactivated Hepatitis B Virus Vaccine - [EPC] (Established Pharmacologic Class)
  • Inactivated Poliovirus Vaccine - [EPC] (Established Pharmacologic Class)
  • Pertussis Vaccine - [CS]
  • Poliovirus Vaccines - [CS]
  • Tetanus Toxoid - [CS]
  • Vaccines, Inactivated - [CS]
    • Sample Package:
    No
    FDA Application Number:
    BLA125563
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    12-21-2018
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    63361-243-1010 VIAL, SINGLE-DOSE in 1 PACKAGE / .5 mL in 1 VIAL, SINGLE-DOSE (63361-243-58)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 63361-243-15?

    The NDC Packaged Code 63361-243-15 is assigned to a 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. The product's dosage form is injection, suspension and is administered via intramuscular form.

    Is NDC 63361-243 included in the NDC Directory?

    Yes, Vaxelis with product code 63361-243 is active and included in the NDC Directory. The product was first marketed by Msp Vaccine Company on December 21, 2018 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 63361-243-15?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 63361-243-15?

    The 11-digit format is 63361024315. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-263361-243-155-4-263361-0243-15