NDC Package 64778-0376-3 Denti-care Denti-foam Topical Sodium Fluoride Mint

View Billable Units, 11-Digit Format, RxNorm

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

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:
64778-0376-3
Package Description:
12 BOTTLE, SPRAY in 1 CASE / 125 g in 1 BOTTLE, SPRAY (64778-0376-1)
Product Code:
Proprietary Name:
Denti-care Denti-foam Topical Sodium Fluoride Mint
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:
64778037603
Labeler Name:
Amd Medicom Inc.
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
Listing Expiration Date:
05-31-2024
Exclude Flag:
D
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.

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Frequently Asked Questions

What is NDC 64778-0376-3?

The NDC Packaged Code 64778-0376-3 is assigned to a package of 12 bottle, spray in 1 case / 125 g in 1 bottle, spray (64778-0376-1) of Denti-care Denti-foam Topical Sodium Fluoride Mint, labeled by Amd Medicom Inc.. The product's dosage form is and is administered via form.

Is NDC 64778-0376 included in the NDC Directory?

No, Denti-care Denti-foam Topical Sodium Fluoride Mint with product code 64778-0376 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Amd Medicom Inc. on May 01, 2003 and its listing in the NDC Directory is set to expire on May 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 64778-0376-3?

The 11-digit format is 64778037603. 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
5-4-164778-0376-35-4-264778-0376-03