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  5. NDC Package Code: 69208-000-00 Sodium Iodide I-131

NDC Package 69208-000-00 Sodium Iodide I-131

Kit 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:
69208-000-00
Package Description:
1 KIT in 1 BOX * 3 SOLUTION, CONCENTRATE in 1 VIAL, DISPENSING (69208-003-35) * 2 SOLUTION, CONCENTRATE in 1 VIAL, DISPENSING (69208-003-25) * 1 CARTON in 1 BOX / 2 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK * 1 SOLUTION, CONCENTRATE in 1 VIAL, DISPENSING (69208-003-15)
Product Code:
69208-000
Proprietary Name:
Sodium Iodide I-131
Non-Proprietary Name:
Sodium Iodide I-131
Usage Information:
Sodium Iodide I-131 is indicated for the treatment of hyperthyroidism and selected cases of thyroid carcinoma.
11-Digit NDC Billing Format:
69208000000
Product Type:
Human Prescription Drug
Labeler Name:
International Isotopes Inc
Dosage Form:
Kit - A packaged collection of related material.
Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Sample Package:
    No
    FDA Application Number:
    ANDA209166
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-16-2020
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:
    • 69208 - International Isotopes Inc
      • 69208-000 - Sodium Iodide I-131
        • 69208-000-00 - 1 KIT in 1 BOX * 3 SOLUTION, CONCENTRATE in 1 VIAL, DISPENSING (69208-003-35) * 2 SOLUTION, CONCENTRATE in 1 VIAL, DISPENSING (69208-003-25) * 1 CARTON in 1 BOX / 2 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK * 1 SOLUTION, CONCENTRATE in 1 VIAL, DISPENSING (69208-003-15)

    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 69208-000-00?

    The NDC Packaged Code 69208-000-00 is assigned to a package of 1 kit in 1 box * 3 solution, concentrate in 1 vial, dispensing (69208-003-35) * 2 solution, concentrate in 1 vial, dispensing (69208-003-25) * 1 carton in 1 box / 2 blister pack in 1 carton / 10 capsule in 1 blister pack * 1 solution, concentrate in 1 vial, dispensing (69208-003-15) of Sodium Iodide I-131, a human prescription drug labeled by International Isotopes Inc. The product's dosage form is kit and is administered via oral form.

    Is NDC 69208-000 included in the NDC Directory?

    Yes, Sodium Iodide I-131 with product code 69208-000 is active and included in the NDC Directory. The product was first marketed by International Isotopes Inc on March 16, 2020 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 69208-000-00?

    The 11-digit format is 69208000000. 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
    5-3-269208-000-005-4-269208-0000-00