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  5. NDC Package Code: 64778-0446-3 Denti-care Denti-rinse Neutral Sodium Fluoride Oral Rinse

NDC Package 64778-0446-3 Denti-care Denti-rinse Neutral Sodium Fluoride Oral Rinse

Sodium Fluoride Liquid Dental - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
64778-0446-3
Package Description:
12 BOTTLE, PUMP in 1 CASE / 1900 mL in 1 BOTTLE, PUMP (64778-0446-1)
Product Code:
64778-0446
Proprietary Name:
Denti-care Denti-rinse Neutral Sodium Fluoride Oral Rinse
Non-Proprietary Name:
Sodium Fluoride
Substance Name:
Sodium Fluoride
Usage Information:
Indications: Topical anti-carie solution. Neutral pH is safe for patients with crowns and restorations. Directions: Dispense 10mL of solution into a measuring cup. Instruct patient to rinse vigorously for 60 seconds, around and in between teeth, then expectorate. For maximum benefit, repeat the rinse procedure with an additional 10mL. Advise patient not to eat, drink or rinse for 30 minutes after application.Pro-Rinse solution may also be applied with a cotton tip applicator to teeth isolated with cotton rolls
11-Digit NDC Billing Format:
64778044603
NDC to RxNorm Crosswalk:
  • RxCUI: 251960 - sodium fluoride 2 % Oral Rinse
  • RxCUI: 251960 - sodium fluoride 20 MG/ML Mouthwash
  • RxCUI: 991007 - Denti-Care DENTI-RINSE 2 % Oral Rinse
  • RxCUI: 991007 - sodium fluoride 20 MG/ML Mouthwash [DentiCare Neutral]
  • RxCUI: 991007 - DentiCare Neutral 2 % Mouthwash
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Amd Medicom
    Dosage Form:
    Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
    Administration Route(s):
  • Dental - Administration to a tooth or teeth.
    • Active Ingredient(s):
  • SODIUM FLUORIDE .02 g/mL
    • Sample Package:
    No
    Marketing Category:
    UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
    Start Marketing Date:
    03-01-2001
    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 64778-0446-3?

    The NDC Packaged Code 64778-0446-3 is assigned to a package of 12 bottle, pump in 1 case / 1900 ml in 1 bottle, pump (64778-0446-1) of Denti-care Denti-rinse Neutral Sodium Fluoride Oral Rinse, a human prescription drug labeled by Amd Medicom. The product's dosage form is liquid and is administered via dental form.

    Is NDC 64778-0446 included in the NDC Directory?

    Yes, Denti-care Denti-rinse Neutral Sodium Fluoride Oral Rinse with product code 64778-0446 is active and included in the NDC Directory. The product was first marketed by Amd Medicom on March 01, 2001 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 64778-0446-3?

    The 11-digit format is 64778044603. 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
    5-4-164778-0446-35-4-264778-0446-03