Respiratory Syncytial Virus Vaccine Suspension
NDC Package 68263-003-10

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.

Respiratory Syncytial Virus Vaccine suspension is a vaccine. This formulation utilizes a suspension delivery system. Marketed by Rovi Pharma Industrial Services S.a., this product is identified by NDC 68263-003.

Identification & Billing

NDC Package Code
68263-003-10
Package Description
10 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE (68263-003-11)
Product Code
68263-003
11-Digit Billing Format
68263000310

Clinical Specifications

Proprietary Name
Respiratory Syncytial Virus Vaccine
Non-Proprietary Name
Respiratory Syncytial Virus Vaccine
Substance Name
Rna-100-ar02
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Active Ingredient(s)
RNA-100-AR02 50 ug/.5mL

Regulatory & Marketing

Labeler Name
Rovi Pharma Industrial Services S.a.
Product Type
Vaccine
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
05-31-2024
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 68263-003-10 identifies a specific commercial package of 10 syringe in 1 carton / .5 ml in 1 syringe (68263-003-11) of Respiratory Syncytial Virus Vaccine (UNFINISHED drug), a vaccine label labeled by Rovi Pharma Industrial Services S.a.. This suspension is formulated for use and contains rna-100-ar02 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 Rovi Pharma Industrial Services S.a. on May 31, 2024. The current certification is valid through December 31, 2026.

How is this Rovi Pharma Industrial Services S.a. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68263000310. 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 (5-3-2)
68263-003-10
11-Digit CMS (5-4-2)
68263-0003-10

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