Sodium Fluoride F 18
NDC Package 60055-623-30

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Sodium Fluoride F 18 is a . Marketed by Jubilant Drax Image Radiopharmacies, Inc. Dba Jubilant Radiopharma, this product is identified by NDC 60055-623 and is authorized under FDA application ANDA203968.

Identification & Billing

NDC Package Code
60055-623-30
Package Description
30 mL in 1 VIAL
Product Code
60055-623
11-Digit Billing Format
60055062330

Clinical Specifications

Proprietary Name
Sodium Fluoride F 18
Dosage Form
-

Regulatory & Marketing

Labeler Name
Jubilant Drax Image Radiopharmacies, Inc. Dba Jubilant Radiopharma
FDA Application #
ANDA203968
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-26-2011
End Marketing Date
04-01-2022
Listing Expiration
04-01-2022
Exclude Flag
D
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 60055-623-30 identifies a specific commercial package of 30 ml in 1 vial of Sodium Fluoride F 18, labeled by Jubilant Drax Image Radiopharmacies, Inc. Dba Jubilant Radiopharma. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Jubilant Drax Image Radiopharmacies, Inc. Dba Jubilant Radiopharma on January 26, 2011. The current certification is valid through April 01, 2022.

How is this Jubilant Drax Image Radiopharmacies, Inc. Dba Jubilant Radiopharma product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60055062330. 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)
60055-623-30
11-Digit CMS (5-4-2)
60055-0623-30

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