Prescription medicine
Ammonia n 13
Ammonia n 13 is a prescription medicine with an FDA approval on record since 2007. FDA's NDC Directory lists it from 17 generic labelers.
- Generic listed
Check it at the source: the ammonia n 13 FDA label on DailyMed (effective October 30, 2019, THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH); the NDA 22119 record on Drugs@FDA; every ammonia n 13 label on DailyMed.
Highlights of the record
FDA label of October 30, 2019; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageAmmonia N 13 Injection is indicated for diagnostic Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease.
Forms and strengths
Injection; injection (solution).
On the market
- Earliest approval on file
- August 23, 2007 Ammonia N 13, Feinstein; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 30 first December 14, 2012; 23 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 18 of which 17 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
- FAERS reports
- 57 through July 30, 2026
What is ammonia n 13 used for?
From the label: indications and usageAmmonia N 13 Injection is indicated for diagnostic Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease. Ammonia N 13 Injection is a radioactive diagnostic agent for Positron Emission Tomography (PET) indicated for diagnostic PET imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease.
FDA pharmacologic class: Radioactive Diagnostic Agent.
Source: FDA drug label (Ammonia N 13), THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH, effective October 30, 2019 (SPL set c857724f-b172-4844-ad42-6fa4c42b0405), via openFDA; the full label on DailyMed
Is there a generic for ammonia n 13?
The FDA approved the first generic ammonia n 13 on December 14, 2012. 30 generic applications are approved; 23 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists ammonia n 13 from 17 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2007 earliest approval on file
- 2012 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for ammonia n 13?
The FDA Adverse Event Reporting System holds 57 reports that list ammonia n 13 among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 8 are coded as a death and 25 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other radioactive diagnostic agents
- the pharmacologic class, with prices and generics
- Ammonia n 13 side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other