Sodium Fluoride
NDC Package 47584-002-01

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 is a medication used to prevent cavities. Marketed by Houston Cyclotron Partners Lp Dba Cyclotope, this product is identified by NDC 47584-002 and is authorized under FDA application ANDA203544.

Identification & Billing

NDC Package Code
47584-002-01
Package Description
30 mL in 1 VIAL, GLASS
Product Code
47584-002
11-Digit Billing Format
47584000201

Clinical Specifications

Proprietary Name
Sodium Fluoride F 18
Dosage Form
-
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
Houston Cyclotron Partners Lp Dba Cyclotope
FDA Application #
ANDA203544
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-08-2011
End Marketing Date
05-11-2020
Listing Expiration
05-11-2020
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 47584-002-01 identifies a specific commercial package of 30 ml in 1 vial, glass of Sodium Fluoride F 18, labeled by Houston Cyclotron Partners Lp Dba Cyclotope. 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 Houston Cyclotron Partners Lp Dba Cyclotope on December 08, 2011. The current certification is valid through May 11, 2020.

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 Houston Cyclotron Partners Lp Dba Cyclotope product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 47584000201. 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)
47584-002-01
11-Digit CMS (5-4-2)
47584-0002-01

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