Sodium Fluoride Injection
NDC Package 52768-125-50

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

Package Information

Sodium Fluoride (sodium fluoride f-18) injection is a medication used to prevent cavities. This formulation utilizes a injection delivery system. Marketed by Precision Nuclear Llc, this product is identified by NDC 52768-125 and is authorized under FDA application ANDA204542.

Identification & Billing

NDC Package Code
52768-125-50
Package Description
50 mL in 1 VIAL, MULTI-DOSE
Product Code
52768-125
11-Digit Billing Format
52768012550

Clinical Specifications

Proprietary Name
Sodium Fluoride F 18
Non-Proprietary Name
Sodium Fluoride F-18
Substance Name
Sodium Fluoride F-18
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
SODIUM FLUORIDE F-18 200 mCi/mL
Pharmacologic Class
Usage Information
This medication is used to prevent cavities. It makes teeth stronger and more resistant to decay caused by acid and bacteria. Talk to your dentist or doctor about the benefits and risks of this product. This medication is not recommended for use in infants less than 6 months of age. This medication is not recommended for use in areas where the fluoride content in the water supply is greater than 0.6 parts per million. See Notes section for more information.

Regulatory & Marketing

Labeler Name
Precision Nuclear Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA204542
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-01-2011
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (52768-125). Click a package code to view its specific billing and regulatory data.

52768-125-30
30 mL in 1 VIAL, MULTI-DOSE

* 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 52768-125-50 identifies a specific commercial package of 50 ml in 1 vial, multi-dose of Sodium Fluoride F 18, a human prescription drug labeled by Precision Nuclear Llc. This injection is formulated for intravenous use and contains sodium fluoride f-18 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 Precision Nuclear Llc on January 01, 2011. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to prevent cavities. It makes teeth stronger and more resistant to decay caused by acid and bacteria. Talk to your dentist or doctor about the benefits and risks of this product. This medication is not recommended for use in infants less than 6 months of age. This medication is not recommended for use in areas where the fluoride content in the water supply is greater than 0.6 parts per million. See Notes section for more information.

How is this Precision Nuclear Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52768012550. 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)
52768-125-50
11-Digit CMS (5-4-2)
52768-0125-50

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