Pneumococcal 15-valent Conjugate Vaccine Crm197 Protein Adsorbed Injection, Suspension
NDC Package 69497-0134-0

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 15-valent Conjugate Vaccine Crm197 Protein Adsorbed injection is a licensed vaccine bulk intermediate utilized for pharmaceutical compounding or manufacturing. This formulation utilizes a injection, suspension delivery system. Marketed by Msd Ireland (carlow), this product is identified by NDC 69497-0134.

Identification & Billing

NDC Package Code
69497-0134-0
Package Description
100 SYRINGE, GLASS in 1 TRAY / .5 mL in 1 SYRINGE, GLASS
Product Code
69497-0134
11-Digit Billing Format
69497013400

Clinical Specifications

Proprietary Name
Pneumococcal 15-valent Conjugate Vaccine Crm197 Protein Adsorbed
Non-Proprietary Name
Pneumococcal 15-valent Conjugate Vaccine Crm197 Protein Adsorbed
Substance Name
Corynebacterium Diphtheriae Crm197 Protein; Streptococcus Pneumoniae Type 1 Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 14 Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 18c Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 19a Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 19f Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 22f Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 23f Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 3 Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 33f Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 4 Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 5 Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 6a Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 6b Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 7f Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 9v Capsular Polysaccharide Diphtheria Crm197 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.
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
07-18-2021
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 69497-0134-0 identifies a specific commercial package of 100 syringe, glass in 1 tray / .5 ml in 1 syringe, glass of Pneumococcal 15-valent Conjugate Vaccine Crm197 Protein Adsorbed (UNFINISHED drug), licensed vaccine bulk intermediate labeled by Msd Ireland (carlow). This injection, suspension is formulated for use and contains corynebacterium diphtheriae crm197 protein; streptococcus pneumoniae type 1 capsular polysaccharide diphtheria crm197 protein conjugate antigen; streptococcus pneumoniae type 14 capsular polysaccharide diphtheria crm197 protein conjugate antigen; streptococcus pneumoniae type 18c capsular polysaccharide diphtheria crm197 protein conjugate antigen; streptococcus pneumoniae type 19a capsular polysaccharide diphtheria crm197 protein conjugate antigen; streptococcus pneumoniae type 19f capsular polysaccharide diphtheria crm197 protein conjugate antigen; streptococcus pneumoniae type 22f capsular polysaccharide diphtheria crm197 protein conjugate antigen; streptococcus pneumoniae type 23f capsular polysaccharide diphtheria crm197 protein conjugate antigen; streptococcus pneumoniae type 3 capsular polysaccharide diphtheria crm197 protein conjugate antigen; streptococcus pneumoniae type 33f capsular polysaccharide diphtheria crm197 protein conjugate antigen; streptococcus pneumoniae type 4 capsular polysaccharide diphtheria crm197 protein conjugate antigen; streptococcus pneumoniae type 5 capsular polysaccharide diphtheria crm197 protein conjugate antigen; streptococcus pneumoniae type 6a capsular polysaccharide diphtheria crm197 protein conjugate antigen; streptococcus pneumoniae type 6b capsular polysaccharide diphtheria crm197 protein conjugate antigen; streptococcus pneumoniae type 7f capsular polysaccharide diphtheria crm197 protein conjugate antigen; streptococcus pneumoniae type 9v 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 July 18, 2021. 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: 69497013400. 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)
69497-0134-0
11-Digit CMS (5-4-2)
69497-0134-00

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