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  5. NDC Package Code: 65857-300-30 Sodium Fluoride F18

NDC Package 65857-300-30 Sodium Fluoride F18

Sodium Fluoride F18 Injection Intravenous - 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:
65857-300-30
Package Description:
30 mL in 1 VIAL, GLASS
Product Code:
65857-300
Proprietary Name:
Sodium Fluoride F18
Non-Proprietary Name:
Sodium Fluoride F18
Substance Name:
Sodium Fluoride F-18
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:
65857030030
Product Type:
Human Prescription Drug
Labeler Name:
Cardinal Health 414, Llc
Dosage Form:
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • SODIUM FLUORIDE F-18 200 mCi/mL
    • Pharmacologic Class(es):
  • Radioactive Diagnostic Agent - [EPC] (Established Pharmacologic Class)
  • Radiopharmaceutical Activity - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA203780
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-30-2015
    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 65857-300-30?

    The NDC Packaged Code 65857-300-30 is assigned to a package of 30 ml in 1 vial, glass of Sodium Fluoride F18, a human prescription drug labeled by Cardinal Health 414, Llc. The product's dosage form is injection and is administered via intravenous form.

    Is NDC 65857-300 included in the NDC Directory?

    Yes, Sodium Fluoride F18 with product code 65857-300 is active and included in the NDC Directory. The product was first marketed by Cardinal Health 414, Llc on July 30, 2015 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 65857-300-30?

    The 11-digit format is 65857030030. 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
    5-3-265857-300-305-4-265857-0300-30