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  5. NDC Package Code: 58657-322-50 Sodium Fluoride

NDC Package 58657-322-50 Sodium Fluoride

Solution/ Drops 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:
58657-322-50
Package Description:
50 mL in 1 BOTTLE, DROPPER
Product Code:
58657-322
Proprietary Name:
Sodium Fluoride
Non-Proprietary Name:
Sodium Fluoride
Substance Name:
Sodium Fluoride
Usage Information:
This medication is used to prevent cavities. It makes teeth stronger and more resistant to decay caused by acid and bacteria. Talk to your dentist or doctor about the benefits and risks of this product. This medication is not recommended for use in infants less than 6 months of age. This medication is not recommended for use in areas where the fluoride content in the water supply is greater than 0.6 parts per million. See Notes section for more information.
11-Digit NDC Billing Format:
58657032250
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
50 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 315102 - sodium fluoride 0.5 MG in 1 mL Oral Solution
  • RxCUI: 315102 - sodium fluoride 1.1 MG/ML Oral Solution
  • RxCUI: 315102 - sodium fluoride 0.11 % Oral Drops
  • RxCUI: 315102 - sodium fluoride 1.1 MG (fluoride ion 0.5 MG) per ML Oral Drops
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Method Pharmaceuticals, Llc
    Dosage Form:
    Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • SODIUM FLUORIDE .5 mg/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:
    08-15-2018
    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 58657-322-50?

    The NDC Packaged Code 58657-322-50 is assigned to a package of 50 ml in 1 bottle, dropper of Sodium Fluoride, a human prescription drug labeled by Method Pharmaceuticals, Llc. The product's dosage form is solution/ drops and is administered via oral form.

    Is NDC 58657-322 included in the NDC Directory?

    Yes, Sodium Fluoride with product code 58657-322 is active and included in the NDC Directory. The product was first marketed by Method Pharmaceuticals, Llc on August 15, 2018 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 NDC billing unit for package 58657-322-50?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 50.

    What is the 11-digit format for NDC 58657-322-50?

    The 11-digit format is 58657032250. 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
    5-3-258657-322-505-4-258657-0322-50