Sodium Flouride Paste, Dentifrice
NDC Package 42291-741-51

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

Package Information

Sodium Flouride (sodium fluoride) pastes is a dental caries preventive; for once daily self-applied topical use. This formulation utilizes a paste, dentifrice delivery system. Marketed by Avkare, this product is identified by NDC 42291-741.

Identification & Billing

NDC Package Code
42291-741-51
Package Description
1 TUBE in 1 CARTON / 53.2 mL in 1 TUBE
Product Code
42291-741
11-Digit Billing Format
42291074151
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.

Clinical Specifications

Proprietary Name
Sodium Flouride
Non-Proprietary Name
Sodium Fluoride
Substance Name
Sodium Fluoride
Dosage Form
Paste, Dentifrice - A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.
Administration Route
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
SODIUM FLUORIDE 5 mg/mL
Usage Information
A dental caries preventive; for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safeand extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 SodiumFluoride 1.1% toothpaste in a squeeze-tube is easily applied onto a toothbrush. This prescription dental toothpaste shouldbe used once daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May beused whether or not drinking water is fluoridated, since topical fluoride cannot produce fluorosis. (See WARNINGS forexception.)

Regulatory & Marketing

Labeler Name
Avkare
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
09-20-2019
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 42291-741-51 identifies a specific commercial package of 1 tube in 1 carton / 53.2 ml in 1 tube of Sodium Flouride, a human prescription drug labeled by Avkare. This paste, dentifrice is formulated for dental use and contains sodium fluoride 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 Avkare on September 20, 2019. The current certification is valid through December 31, 2027.

How is this Avkare product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42291074151. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. 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)
42291-741-51
11-Digit CMS (5-4-2)
42291-0741-51

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