NDC Package 57511-0201-1 Stance

0.63% Stannous Fluoride Concentrate Rinse Rinse Topical - View Billable Units, 11-Digit Format, RxNorm

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:
57511-0201-1
Package Description:
225 mL in 1 BOTTLE, PUMP
Product Code:
Proprietary Name:
Stance
Non-Proprietary Name:
0.63% Stannous Fluoride Concentrate Rinse
Substance Name:
Stannous Fluoride
Usage Information:
Uses • aids in the prevention of dental decay • helps prevent gingivitis • helps control plaque bacteria • builds increasing protection against painful tooth sensitivity
11-Digit NDC Billing Format:
57511020101
NDC to RxNorm Crosswalk:
  • RxCUI: 583459 - stannous fluoride 0.63 % Dental Solution
  • RxCUI: 583459 - stannous fluoride 6.3 MG/ML Mouthwash
  • RxCUI: 583459 - stannous fluoride 0.63 % (fluoride ion 0.12 % ) Dental Solution
  • Product Type:
    Human Otc Drug
    Labeler Name:
    Elevate Oral Care
    Dosage Form:
    Rinse - A liquid used to cleanse by flushing.
    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):
    Sample Package:
    No
    FDA Application Number:
    M021
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    08-25-2016
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 57511-0201-1?

    The NDC Packaged Code 57511-0201-1 is assigned to a package of 225 ml in 1 bottle, pump of Stance, a human over the counter drug labeled by Elevate Oral Care. The product's dosage form is rinse and is administered via topical form.

    Is NDC 57511-0201 included in the NDC Directory?

    Yes, Stance with product code 57511-0201 is active and included in the NDC Directory. The product was first marketed by Elevate Oral Care on August 25, 2016 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 11-digit format for NDC 57511-0201-1?

    The 11-digit format is 57511020101. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    5-4-157511-0201-15-4-257511-0201-01