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Prescription medicine

Choline C-11

Drug class: Radioactive Diagnostic Agent

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
None listedFDA shortage list
0Recalls (FDA reports)
1Companies
2012First FDA approval on file

Quick answers

What is Choline C-11 used for?
The FDA-approved label (Choline C 11, Mayo Clinic, December 26, 2025) says: “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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Choline C-11 have a boxed warning?
No. None of the 1 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Choline C-11?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Choline C-11 been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Choline C-11?
1 company lists prescription products of Choline C-11 in the FDA NDC Directory, including Mayo Clinic.

What Choline C-11 is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

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. …

— FDA label: Choline C 11, Mayo Clinic, effective December 26, 2025. Read the full label on DailyMed →

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Prostate cancer

Related medical specialties

OncologyUrology

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

Forms and how it is given

Dosage formsInjection
RouteIntravenous
Prescription products1 in the FDA NDC Directory

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA203155
CHOLINE C-11		 McprfSeptember 12, 2012 6, latest September 9, 2024
2024: Labeling · 2015: Manufacturing (CMC) · 2015: Manufacturing (CMC)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

SPL set ID of the quoted label8e046642-5038-4094-b1bb-a1915558fb1c
FDA labels (SPL)1
FDA applicationsNDA203155
Active ingredients (FDA)CHOLINE C-11

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Choline C 11, Mayo Clinic, effective December 26, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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