Capvaxive Injection, Solution
NDC Package 0006-4347-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. Frequently Asked Questions

Package Information

Capvaxive (pneumococcal 21-valent conjugate vaccine) injection is cAPVAXIVE™ is indicated for:active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in individuals 18 years of age and older.active immunization for the prevention of pneumonia caused by S. This formulation utilizes a injection, solution delivery system. Marketed by Merck Sharp & Dohme Llc, this product is identified by NDC 0006-4347 and is authorized under FDA application BLA125814.

Identification & Billing

NDC Package Code
0006-4347-01
Package Description
1 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE (0006-4347-99)
Product Code
0006-4347
11-Digit Billing Format
00006434701
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 2686972 - pneumococcal 21-valent conjugate vaccine (PCV21) 0.5 ML Prefilled Syringe
  • RxCUI: 2686972 - 0.5 ML Streptococcus pneumoniae serotype 10A capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 11A capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 12F capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 15A capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 16F capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 17F capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 19A capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 20A capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 22F capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 23A capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 23B capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 24F capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 3 capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 31 capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 33F capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 35B capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 6A capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 7F capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 8 capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 9N capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype DEOAC15B capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML Prefilled Syringe
  • RxCUI: 2686972 - pneumococcal 21-valent conjugate vaccine (diphtheria CRM197 Protein) 0.5 ML Prefilled Syringe
  • RxCUI: 2686978 - CAPVAXIVE vaccine 0.5 ML Prefilled Syringe
  • RxCUI: 2686978 - 0.5 ML Streptococcus pneumoniae serotype 10A capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 11A capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 12F capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 15A capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 16F capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 17F capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 19A capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 20A capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 22F capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 23A capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 23B capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 24F capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 3 capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 31 capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 33F capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 35B capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 6A capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 7F capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 8 capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype 9N capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML / Streptococcus pneumoniae serotype DEOAC15B capsular antigen diphtheria CRM197 protein conjugate vaccine 0.008 MG/ML Prefilled Syringe [Capvaxive]

Clinical Specifications

Proprietary Name
Capvaxive
Non-Proprietary Name
Pneumococcal 21-valent Conjugate Vaccine
Substance Name
Corynebacterium Diphtheriae Crm197 Protein; Streptococcus Pneumoniae Type 10a Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 11a Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 12f Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 15a Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 16f Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 17f Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 19a Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 20a Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 22f Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 23a Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 23b Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 24f Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 3 Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 31 Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 33f Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 35b Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 6a Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 7f Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 8 Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 9n Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type Deoac15b Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intramuscular - Administration within a muscle.
Active Ingredient(s)
Pharmacologic Class
Usage Information
CAPVAXIVE™ is indicated for:active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in individuals 18 years of age and older.active immunization for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in individuals 18 years of age and older.The indication for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA) [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Regulatory & Marketing

Labeler Name
Merck Sharp & Dohme Llc
Product Type
Vaccine
FDA Application #
BLA125814
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
06-17-2024
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

90684
Source: AWP
PCV21 VACCINE IM
HCPCS Dosage 1 EA
Units / Pkg 1

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0006-4347). Click a package code to view its specific billing and regulatory data.

0006-4347-02
10 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE (0006-4347-99)

* 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 0006-4347-01 identifies a specific commercial package of 1 syringe in 1 carton / .5 ml in 1 syringe (0006-4347-99) of Capvaxive, a vaccine label labeled by Merck Sharp & Dohme Llc. This injection, solution is formulated for intramuscular use and contains corynebacterium diphtheriae crm197 protein; streptococcus pneumoniae type 10a capsular polysaccharide diphtheria crm197 protein conjugate antigen; streptococcus pneumoniae type 11a capsular polysaccharide diphtheria crm197 protein conjugate antigen; streptococcus pneumoniae type 12f capsular polysaccharide diphtheria crm197 protein conjugate antigen; streptococcus pneumoniae type 15a capsular polysaccharide diphtheria crm197 protein conjugate antigen; streptococcus pneumoniae type 16f capsular polysaccharide diphtheria crm197 protein conjugate antigen; streptococcus pneumoniae type 17f capsular polysaccharide diphtheria crm197 protein conjugate antigen; streptococcus pneumoniae type 19a capsular polysaccharide diphtheria crm197 protein conjugate antigen; streptococcus pneumoniae type 20a capsular polysaccharide diphtheria crm197 protein conjugate antigen; streptococcus pneumoniae type 22f capsular polysaccharide diphtheria crm197 protein conjugate antigen; streptococcus pneumoniae type 23a capsular polysaccharide diphtheria crm197 protein conjugate antigen; streptococcus pneumoniae type 23b capsular polysaccharide diphtheria crm197 protein conjugate antigen; streptococcus pneumoniae type 24f capsular polysaccharide diphtheria crm197 protein conjugate antigen; streptococcus pneumoniae type 3 capsular polysaccharide diphtheria crm197 protein conjugate antigen; streptococcus pneumoniae type 31 capsular polysaccharide diphtheria crm197 protein conjugate antigen; streptococcus pneumoniae type 33f capsular polysaccharide diphtheria crm197 protein conjugate antigen; streptococcus pneumoniae type 35b capsular polysaccharide diphtheria crm197 protein conjugate antigen; streptococcus pneumoniae type 6a capsular polysaccharide diphtheria crm197 protein conjugate antigen; streptococcus pneumoniae type 7f capsular polysaccharide diphtheria crm197 protein conjugate antigen; streptococcus pneumoniae type 8 capsular polysaccharide diphtheria crm197 protein conjugate antigen; streptococcus pneumoniae type 9n capsular polysaccharide diphtheria crm197 protein conjugate antigen; streptococcus pneumoniae type deoac15b capsular polysaccharide diphtheria crm197 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 June 17, 2024. The current certification is valid through December 31, 2026.

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: 00006434701. 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)
0006-4347-01
11-Digit CMS (5-4-2)
00006-4347-01

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