Choline C 11 Injection
NDC Package 52670-556-30

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package 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). This formulation utilizes a injection delivery system. Marketed by Mayo Clinic, this product is identified by NDC 52670-556 and is authorized under FDA application NDA203155.

Identification & Billing

NDC Package Code
52670-556-30
Package Description
30 mL in 1 VIAL
Product Code
52670-556
11-Digit Billing Format
52670055630

Clinical Specifications

Proprietary Name
Choline C 11
Non-Proprietary Name
Choline C-11
Substance Name
Choline C-11
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
CHOLINE C-11 33.1 mCi/mL
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Mayo Clinic
Product Type
Human Prescription Drug
FDA Application #
NDA203155
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-12-2012
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 52670-556-30 identifies a specific commercial package of 30 ml in 1 vial of Choline C 11, a human prescription drug labeled by Mayo Clinic. This injection is formulated for intravenous use and contains choline c-11 as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Mayo Clinic on September 12, 2012. The current certification is valid through December 31, 2026.

How is this Mayo Clinic product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52670055630. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
52670-556-30
11-Digit CMS (5-4-2)
52670-0556-30

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.