NDC Package 57511-0002-1 Just Right 5000

1.1% Sodium Fluoride Toothpaste Gel, Dentifrice Topical - View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

57511-0002-1

Package Description:

97 g in 1 TUBE

Product Code:

57511-0002

Proprietary Name:

Just Right 5000

Non-Proprietary Name:

1.1% Sodium Fluoride Toothpaste

Substance Name:

Sodium Fluoride

11-Digit NDC Billing Format:

57511000201

Billing Unit:

GM - Billing unit of "gram" is used when a product is measured by its weight.

NDC to RxNorm Crosswalk:

97 GM

NDC to RxNorm Crosswalk:

RxCUI: 392038 - sodium fluoride 1.1 % Toothpaste

RxCUI: 392038 - sodium fluoride 0.011 MG/MG Toothpaste

RxCUI: 392038 - sodium fluoride 1.1 % (fluoride ion 0.5 % ) Toothpaste

RxCUI: 392038 - sodium fluoride 1.1 % Dental Gel

Product Type:

Human Prescription Drug

Labeler Name:

Elevate Oral Care

Dosage Form:

Gel, Dentifrice - A combination of a dentifrice (formulation intended to clean and/or polish the teeth, and which may contain certain additional agents), and a gel. It is used with a toothbrush for the purpose of cleaning and polishing the teeth.

Administration Route(s):

Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Active Ingredient(s):

SODIUM FLUORIDE 1.1 g/100g

Sample Package:

Marketing Category:

UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.

Start Marketing Date:

08-28-2020

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

57511 - Elevate Oral Care
- 57511-0002 - Just Right 5000
  - 57511-0002-1 - 97 g in 1 TUBE

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 disclaimer below.

Frequently Asked Questions

What is NDC 57511-0002-1?

The NDC Packaged Code 57511-0002-1 is assigned to a package of 97 g in 1 tube of Just Right 5000, a human prescription drug labeled by Elevate Oral Care. The product's dosage form is gel, dentifrice and is administered via topical form.This product is billed per "GM" gram and contains an estimated amount of 97 billable units per package.

Is NDC 57511-0002 included in the NDC Directory?

Yes, Just Right 5000 with product code 57511-0002 is active and included in the NDC Directory. The product was first marketed by Elevate Oral Care on August 28, 2020 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 57511-0002-1?

The contents of this package are billed per "gm or gram", products billed per gram are products measured by weight. The calculated billable units for this package is 97.

What is the 11-digit format for NDC 57511-0002-1?

The 11-digit format is 57511000201. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-4-1	57511-0002-1	5-4-2	57511-0002-01

Table of Contents