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  5. NDC Package Code: 52670-556-30 Choline C 11

NDC Package 52670-556-30 Choline C 11

Choline C-11 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:
52670-556-30
Package Description:
30 mL in 1 VIAL
Product Code:
52670-556
Proprietary Name:
Choline C 11
Non-Proprietary Name:
Choline C-11
Substance Name:
Choline C-11
Usage Information:
Choline C 11 Injection is indicated for positron emission tomography (PET) imaging of patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (CT) or magnetic resonance imaging (MRI). In these patients, 11 C-choline PET imaging may help identify potential sites of prostate cancer recurrence for subsequent histologic confirmation. Suspected prostate recurrence is based upon elevated blood prostate specific antigen (PSA) levels following initial therapy. In clinical studies, images were produced with PET/CT coregistration.Limitation of Use: 11 C-choline PET imaging is not a replacement for histologic verification of recurrent prostate cancer.
11-Digit NDC Billing Format:
52670055630
Product Type:
Human Prescription Drug
Labeler Name:
Mayo Clinic
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):
  • CHOLINE C-11 33.1 mCi/mL
    • Pharmacologic Class(es):
  • Radioactive Diagnostic Agent - [EPC] (Established Pharmacologic Class)
  • Radiopharmaceutical Activity - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA203155
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    09-12-2012
    Listing Expiration Date:
    12-31-2025
    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 52670-556-30?

    The NDC Packaged Code 52670-556-30 is assigned to a package of 30 ml in 1 vial of Choline C 11, a human prescription drug labeled by Mayo Clinic. The product's dosage form is injection and is administered via intravenous form.

    Is NDC 52670-556 included in the NDC Directory?

    Yes, Choline C 11 with product code 52670-556 is active and included in the NDC Directory. The product was first marketed by Mayo Clinic on September 12, 2012 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 52670-556-30?

    The 11-digit format is 52670055630. 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
    5-3-252670-556-305-4-252670-0556-30