Sodium Fluoride Injection
NDC Package 76451-018-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. 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 3d Imaging Drug Design And Development Llc, this product is identified by NDC 76451-018 and is authorized under FDA application ANDA203777.

Identification & Billing

NDC Package Code
76451-018-10
Package Description
10 mL in 1 VIAL, GLASS
Product Code
76451-018
11-Digit Billing Format
76451001810

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
3d Imaging Drug Design And Development Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA203777
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-02-2012
Listing Expiration
12-31-2027
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 76451-018-10 identifies a specific commercial package of 10 ml in 1 vial, glass of Sodium Fluoride F 18, a human prescription drug labeled by 3d Imaging Drug Design And Development 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 3d Imaging Drug Design And Development Llc on January 02, 2012. The current certification is valid through December 31, 2027.

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 3d Imaging Drug Design And Development Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76451001810. 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)
76451-018-10
11-Digit CMS (5-4-2)
76451-0018-10

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