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  5. NDC Package Code: 61649-731-01 Bio Spectra Attitude

NDC Package 61649-731-01 Bio Spectra Attitude

Sodium Fluoride Gel, Dentifrice 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:
61649-731-01
Package Description:
120 g in 1 TUBE
Product Code:
61649-731
Proprietary Name:
Bio Spectra Attitude
Non-Proprietary Name:
Sodium Fluoride
Substance Name:
Sodium Fluoride
Usage Information:
Do not swallow. Should be used as part of an oral health program that includes regular flossing and dental check-ups. Brush teeth thoroughly for at least 1 minute twice a day, preferably after each meal, or as directed by a dentist. Children under 6 years of age should use only a pea-sized amount and be supervised to brush properly and to not swallow. Consult a dentist or health care professional before using with children under 2 years of age. Store at room temperature (15-30 °C).
11-Digit NDC Billing Format:
61649073101
NDC to RxNorm Crosswalk:
  • RxCUI: 891775 - sodium fluoride 0.243 % Toothpaste
  • RxCUI: 891775 - sodium fluoride 0.00243 MG/MG Toothpaste
  • RxCUI: 891775 - sodium fluoride 0.243 % (fluoride ion 0.13 % ) Toothpaste
  • RxCUI: 891775 - sodium fluoride 0.243 % (fluoride ion 0.14 % ) Toothpaste
  • RxCUI: 891775 - sodium fluoride 0.243 % (fluoride ion 0.15 % ) Toothpaste
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Attitude Dba 9055-7588 Qu�bec Inc.
    Dosage Form:
    Gel, Dentifrice - A combination of a dentifrice (formulation intended to clean and/or polish the teeth, and which may contain certain additional agents), and a gel. It is used with a toothbrush for the purpose of cleaning and polishing the teeth.
    Administration Route(s):
  • Dental - Administration to a tooth or teeth.
    • Active Ingredient(s):
  • SODIUM FLUORIDE .243 g/100g
    • Sample Package:
    No
    FDA Application Number:
    part355
    Marketing Category:
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date:
    05-15-2021
    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 61649-731-01?

    The NDC Packaged Code 61649-731-01 is assigned to a package of 120 g in 1 tube of Bio Spectra Attitude, a human over the counter drug labeled by Attitude Dba 9055-7588 Qu�bec Inc.. The product's dosage form is gel, dentifrice and is administered via dental form.

    Is NDC 61649-731 included in the NDC Directory?

    Yes, Bio Spectra Attitude with product code 61649-731 is active and included in the NDC Directory. The product was first marketed by Attitude Dba 9055-7588 Qu�bec Inc. on May 15, 2021 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 61649-731-01?

    The 11-digit format is 61649073101. 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
    5-3-261649-731-015-4-261649-0731-01