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  5. NDC Package Code: 71347-500-04 Truguard 5000

NDC Package 71347-500-04 Truguard 5000

Sodium Fluoride Toothpaste Paste, Dentifrice Oral - 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:
71347-500-04
Package Description:
1 TUBE in 1 BOX / 112 g in 1 TUBE
Product Code:
71347-500
Proprietary Name:
Truguard 5000
Non-Proprietary Name:
Sodium Fluoride Toothpaste
Substance Name:
Potassium Nitrate; Sodium Fluoride
Usage Information:
INDICATIONS AND USAGE: A dental caries preventive; for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators. 1-4 TruGuard brand of 1.1% sodium fluoride in a squeeze tube is easily applied onto a toothbrush. This prescription dental cream should be used once daily in place of your regular toothpaste unless otherwise instructed by your dental professional. May be used whether or not drinking water is fluoridated, since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)
11-Digit NDC Billing Format:
71347050004
Product Type:
Human Prescription Drug
Labeler Name:
The Atlanta Dental Supply Company Dba Advanced Dental Products
Dosage Form:
Paste, Dentifrice - A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.
Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • POTASSIUM NITRATE 5 g/100g
  • SODIUM FLUORIDE 1.1 g/100g
    • 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:
    03-16-2023
    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 71347-500-04?

    The NDC Packaged Code 71347-500-04 is assigned to a package of 1 tube in 1 box / 112 g in 1 tube of Truguard 5000, a human prescription drug labeled by The Atlanta Dental Supply Company Dba Advanced Dental Products. The product's dosage form is paste, dentifrice and is administered via oral form.

    Is NDC 71347-500 included in the NDC Directory?

    Yes, Truguard 5000 with product code 71347-500 is active and included in the NDC Directory. The product was first marketed by The Atlanta Dental Supply Company Dba Advanced Dental Products on March 16, 2023 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 71347-500-04?

    The 11-digit format is 71347050004. 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 5-3-2 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
    5-3-271347-500-045-4-271347-0500-04