Fluoride Drops
NDC Package 0288-5523-01

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 inactivated by the FDA.

Fluoride Drops is cONTRAINDICATIONS: PATIENTS WITH MEDICAL CONDITION OF DENTAL FLUOROSIS. Marketed by Fluoritab Corporation, this product is identified by NDC 0288-5523.

Identification & Billing

NDC Package Code
0288-5523-01
Package Description
30 mL in 1 BOTTLE, DROPPER
Product Code
0288-5523
11-Digit Billing Format
00288552301
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
30 ML
RxNorm Crosswalk
  • RxCUI: 392046 - sodium fluoride 2.5 MG in 1 mL Oral Solution
  • RxCUI: 392046 - sodium fluoride 5.56 MG/ML Oral Solution
  • RxCUI: 392046 - sodium fluoride 5.56 MG (fluoride ion 2.5 MG) per 1 ML Oral Drops

Clinical Specifications

Proprietary Name
Fluoride Drops
Dosage Form
-
Usage Information
CONTRAINDICATIONS: PATIENTS WITH MEDICAL CONDITION OF DENTAL FLUOROSIS.

Regulatory & Marketing

Labeler Name
Fluoritab Corporation
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
01-09-2011
Listing Expiration
12-31-2017
Exclude Flag
I
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 0288-5523-01 identifies a specific commercial package of 30 ml in 1 bottle, dropper of Fluoride Drops, labeled by Fluoritab Corporation. This product is billed per "ML" milliliter and contains an estimated amount of 30 billable units per package. 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 Fluoritab Corporation on January 09, 2011. The current certification is valid through December 31, 2017.

How is this Fluoritab Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00288552301. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 30 total billable units per package. 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 (4-4-2)
0288-5523-01
11-Digit CMS (5-4-2)
00288-5523-01

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