Prescription medicine

Choline c 11

Choline c 11 is a prescription medicine with an FDA approval on record since 2012. No generic is listed in FDA's NDC Directory.

No generic listed

Check it at the source: the choline c 11 FDA label on DailyMed (effective December 26, 2025, Mayo Clinic); the NDA 203155 record on Drugs@FDA; every choline c 11 label on DailyMed.

Highlights of the record

FDA label of December 26, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
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).

Forms and strengths

Injection.

On the market

Earliest approval on file: September 12, 2012 Choline C-11, Mcprf; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 4 first October 29, 2015; 1 with a marketed status in Drugs@FDA
Labelers listed (NDC): 1 of which 0 under generic applications, 1 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded

What is choline c 11 used for?

From the label: indications and usage
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. […]

FDA pharmacologic class: Radioactive Diagnostic Agent.

Source: FDA drug label (Choline C 11), NDA203155 (Mcprf), as published by Mayo Clinic, effective December 26, 2025 (SPL set 8e046642-5038-4094-b1bb-a1915558fb1c), via openFDA; the full label on DailyMed

Is there a generic for choline c 11?

The FDA approved the first generic choline c 11 on October 29, 2015. 4 generic applications are approved; 1 of them carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

2012 earliest approval on file
2015 first generic approved

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What does the choline c 11 label say about other medicines?

The choline c 11 label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine named	Section	What the label says
Colchicine	drug interactions	Colchicine and androgen-deprivation therapeutic drugs may interfere with 11 C-choline PET/CT imaging performance ( 5.1 ).

Check choline c 11 against other medicines

What next?

Other radioactive diagnostic agents: the pharmacologic class, with prices and generics
Check an interaction: what two or more labels say about each other