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  5. NDC Package Code: 64778-0379-3 Denti-care Denti-foam Topical Sodium Fluoride Strawberry

NDC Package 64778-0379-3 Denti-care Denti-foam Topical Sodium Fluoride Strawberry

Sodium Fluoride Aerosol, Foam 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:
64778-0379-3
Package Description:
12 BOTTLE, SPRAY in 1 CASE / 125 g in 1 BOTTLE, SPRAY (64778-0379-1)
Product Code:
64778-0379
Proprietary Name:
Denti-care Denti-foam Topical Sodium Fluoride Strawberry
Non-Proprietary Name:
Sodium Fluoride
Substance Name:
Sodium Fluoride
Usage Information:
Indications: topical anti-caries preparationDirections:Following prophylaxis treatment, fill ¼ of tray with foamTo dispense, shake bottle vigorously then invert applicator 180° downward to the bottom of the trayInsert tray, have patient bite down lightly for a minimum of 60 seconds, up to 4 minutesRemove tray and have patient expectorate excessAdvise patient not to eat, drink or rinse for 30 minutes after the treatmentMedicinal ingredients: Fluoride ions 1.23 % w/w (from 2.72 % w/w sodium fluoride)
11-Digit NDC Billing Format:
64778037903
NDC to RxNorm Crosswalk:
  • RxCUI: 248389 - sodium fluoride 2.72 % Oral Foam
  • RxCUI: 248389 - sodium fluoride 27.2 MG/ML Oral Foam
  • RxCUI: 248389 - sodium fluoride 2.72 % (fluoride ion 1.23 % ) Oral Foam
  • RxCUI: 991013 - Denti-Care Denti-Foam 2.72 % Oral Foam
  • RxCUI: 991013 - sodium fluoride 27.2 MG/ML Oral Foam [DentiCare Denti Foam]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Amd Medicom Inc
    Dosage Form:
    Aerosol, Foam - A dosage form containing one or more active ingredients, surfactants, aqueous or nonaqueous liquids, and the propellants; if the propellant is in the internal (discontinuous) phase (i.e., of the oil-in-water type), a stable foam is discharged, and if the propellant is in the external (continuous) phase (i.e., of the water-in-oil type), a spray or a quick-breaking foam is discharged.
    Administration Route(s):
  • Dental - Administration to a tooth or teeth.
    • Active Ingredient(s):
  • SODIUM FLUORIDE .0272 g/g
    • 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:
    05-01-2003
    End Marketing Date:
    05-31-2024
    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 64778-0379-3?

    The NDC Packaged Code 64778-0379-3 is assigned to a package of 12 bottle, spray in 1 case / 125 g in 1 bottle, spray (64778-0379-1) of Denti-care Denti-foam Topical Sodium Fluoride Strawberry, a human prescription drug labeled by Amd Medicom Inc. The product's dosage form is aerosol, foam and is administered via dental form.

    Is NDC 64778-0379 included in the NDC Directory?

    Yes, Denti-care Denti-foam Topical Sodium Fluoride Strawberry with product code 64778-0379 is active and included in the NDC Directory. The product was first marketed by Amd Medicom Inc on May 01, 2003.

    What is the 11-digit format for NDC 64778-0379-3?

    The 11-digit format is 64778037903. 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
    5-4-164778-0379-35-4-264778-0379-03