Pneumococcal 21-valent Conjugate Vaccine Injection, Solution
NDC Package 69497-0141-0

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Pneumococcal 21-valent Conjugate Vaccine injection is a licensed vaccine bulk intermediate utilized for pharmaceutical compounding or manufacturing. This formulation utilizes a injection, solution delivery system. Marketed by Msd Ireland (carlow), this product is identified by NDC 69497-0141.

Identification & Billing

NDC Package Code
69497-0141-0
Package Description
100 SYRINGE, GLASS in 1 TRAY / .5 mL in 1 SYRINGE, GLASS
Product Code
69497-0141
11-Digit Billing Format
69497014100

Clinical Specifications

Proprietary Name
Pneumococcal 21-valent Conjugate Vaccine
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.
Active Ingredient(s)

Regulatory & Marketing

Labeler Name
Msd Ireland (carlow)
Product Type
Licensed Vaccine Bulk Intermediate
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
06-17-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 69497-0141-0 identifies a specific commercial package of 100 syringe, glass in 1 tray / .5 ml in 1 syringe, glass of Pneumococcal 21-valent Conjugate Vaccine (UNFINISHED drug), licensed vaccine bulk intermediate labeled by Msd Ireland (carlow). This injection, solution is formulated for 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 Msd Ireland (carlow) on June 17, 2024. The current certification is valid through December 31, 2026.

How is this Msd Ireland (carlow) product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69497014100. 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 (5-4-1)
69497-0141-0
11-Digit CMS (5-4-2)
69497-0141-00

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