Prevnar 13 Injection, Suspension
NDC Package 50090-1944-1

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

Package Information

Prevnar 13 (pneumococcal 13-valent conjugate vaccine) injection is this vaccine is used to help protect from infection due to a certain bacteria (Streptococcus pneumoniae). This formulation utilizes a injection, suspension delivery system. Marketed by A-s Medication Solutions, this product is identified by NDC 50090-1944 and is authorized under FDA application BLA125324.

Identification & Billing

NDC Package Code
50090-1944-1
Package Description
1 SYRINGE in 1 POUCH / .5 mL in 1 SYRINGE (50090-1944-0)
Product Code
50090-1944
11-Digit Billing Format
50090194401
RxNorm Crosswalk
  • RxCUI: 901640 - pneumococcal 13-valent conjugate vaccine (PCV13) 0.5 ML Prefilled Syringe
  • RxCUI: 901640 - 0.5 ML Streptococcus pneumoniae serotype 1 capsular antigen diphtheria CRM197 protein conjugate vaccine 0.0044 MG/ML / Streptococcus pneumoniae serotype 14 capsular antigen diphtheria CRM197 protein conjugate vaccine 0.0044 MG/ML / Streptococcus pneumoniae serotype 18C capsular antigen diphtheria CRM197 protein conjugate vaccine 0.0044 MG/ML / Streptococcus pneumoniae serotype 19A capsular antigen diphtheria CRM197 protein conjugate vaccine 0.0044 MG/ML / Streptococcus pneumoniae serotype 19F capsular antigen diphtheria CRM197 protein conjugate vaccine 0.0044 MG/ML / Streptococcus pneumoniae serotype 23F capsular antigen diphtheria CRM197 protein conjugate vaccine 0.0044 MG/ML / Streptococcus pneumoniae serotype 3 capsular antigen diphtheria CRM197 protein conjugate vaccine 0.0044 MG/ML / Streptococcus pneumoniae serotype 4 capsular antigen diphtheria CRM197 protein conjugate vaccine 0.0044 MG/ML / Streptococcus pneumoniae serotype 5 capsular antigen diphtheria CRM197 protein conjugate vaccine 0.0044 MG/ML / Streptococcus pneumoniae serotype 6A capsular antigen diphtheria CRM197 protein conjugate vaccine 0.0044 MG/ML / Streptococcus pneumoniae serotype 6B capsular antigen diphtheria CRM197 protein conjugate vaccine 0.0088 MG/ML / Streptococcus pneumoniae serotype 7F capsular antigen diphtheria CRM197 protein conjugate vaccine 0.0044 MG/ML / Streptococcus pneumoniae serotype 9V capsular antigen diphtheria CRM197 protein conjugate vaccine 0.0044 MG/ML Prefilled Syringe
  • RxCUI: 901640 - pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 Protein) 0.5 ML Prefilled Syringe
  • RxCUI: 901644 - Prevnar 13 vaccine 0.5 ML Prefilled Syringe
  • RxCUI: 901644 - 0.5 ML Streptococcus pneumoniae serotype 1 capsular antigen diphtheria CRM197 protein conjugate vaccine 0.0044 MG/ML / Streptococcus pneumoniae serotype 14 capsular antigen diphtheria CRM197 protein conjugate vaccine 0.0044 MG/ML / Streptococcus pneumoniae serotype 18C capsular antigen diphtheria CRM197 protein conjugate vaccine 0.0044 MG/ML / Streptococcus pneumoniae serotype 19A capsular antigen diphtheria CRM197 protein conjugate vaccine 0.0044 MG/ML / Streptococcus pneumoniae serotype 19F capsular antigen diphtheria CRM197 protein conjugate vaccine 0.0044 MG/ML / Streptococcus pneumoniae serotype 23F capsular antigen diphtheria CRM197 protein conjugate vaccine 0.0044 MG/ML / Streptococcus pneumoniae serotype 3 capsular antigen diphtheria CRM197 protein conjugate vaccine 0.0044 MG/ML / Streptococcus pneumoniae serotype 4 capsular antigen diphtheria CRM197 protein conjugate vaccine 0.0044 MG/ML / Streptococcus pneumoniae serotype 5 capsular antigen diphtheria CRM197 protein conjugate vaccine 0.0044 MG/ML / Streptococcus pneumoniae serotype 6A capsular antigen diphtheria CRM197 protein conjugate vaccine 0.0044 MG/ML / Streptococcus pneumoniae serotype 6B capsular antigen diphtheria CRM197 protein conjugate vaccine 0.0088 MG/ML / Streptococcus pneumoniae serotype 7F capsular antigen diphtheria CRM197 protein conjugate vaccine 0.0044 MG/ML / Streptococcus pneumoniae serotype 9V capsular antigen diphtheria CRM197 protein conjugate vaccine 0.0044 MG/ML Prefilled Syringe [Prevnar 13]

Clinical Specifications

Proprietary Name
Prevnar 13
Non-Proprietary Name
Pneumococcal 13-valent Conjugate Vaccine
Substance Name
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 23f Capsular Polysaccharide Diphtheria Crm197 Protein Conjugate Antigen; Streptococcus Pneumoniae Type 3 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.
Administration Route
Intramuscular - Administration within a muscle.
Active Ingredient(s)
Pharmacologic Class
Usage Information
This vaccine is used to help protect from infection due to a certain bacteria (Streptococcus pneumoniae). This bacteria can cause ear infection or other more serious infections (such as pneumonia, meningitis). Some brands are approved for use only in children, while others can be used in both children and adults. Vaccines may not fully protect everyone who receives them.

Regulatory & Marketing

Labeler Name
A-s Medication Solutions
Product Type
Vaccine
FDA Application #
BLA125324
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
03-12-2010
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50090-1944-1 identifies a specific commercial package of 1 syringe in 1 pouch / .5 ml in 1 syringe (50090-1944-0) of Prevnar 13, a vaccine label labeled by A-s Medication Solutions. This injection, suspension is formulated for intramuscular use and contains 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 23f capsular polysaccharide diphtheria crm197 protein conjugate antigen; streptococcus pneumoniae type 3 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 A-s Medication Solutions on March 12, 2010. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This vaccine is used to help protect from infection due to a certain bacteria (Streptococcus pneumoniae). This bacteria can cause ear infection or other more serious infections (such as pneumonia, meningitis). Some brands are approved for use only in children, while others can be used in both children and adults. Vaccines may not fully protect everyone who receives them.

How is this A-s Medication Solutions product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50090194401. 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)
50090-1944-1
11-Digit CMS (5-4-2)
50090-1944-01

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