Quick answers
- What is Ammonia N-13 used for?
- The FDA-approved label (Ammonia N 13, The Feinstein Institutes for Medical Research, October 30, 2019) says: “Ammonia 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ammonia N-13 have a boxed warning?
- No. None of the 14 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Ammonia N-13?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ammonia N-13 been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Ammonia N-13?
- 18 companies list prescription products of Ammonia N-13 in the FDA NDC Directory, including SOFIE Co. dba SOFIE, UCSF Radiopharmaceutical Facility and Cardinal Health 414, LLC.
What Ammonia N-13 is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Ammonia 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. …
— FDA label: Ammonia N 13, The Feinstein Institutes for Medical Research, effective October 30, 2019. Read the full label on DailyMed →
The FDA has 14 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
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.
Related medical specialties
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.
0 of 14 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection · Injection, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 19 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.
- SOFIE Co. dba SOFIE2 products
- UCSF Radiopharmaceutical Facility1 product
- Cardinal Health 414, LLC1 product
- 3D Imaging Drug Design and Development LLC1 product
- Ionetix Corporation1 product
- Massachusetts General Hospital1 product
- Biomedical Research Foundation of Northwest Louisiana1 product
- PETNET Solutions, Inc.1 product
- The University of Texas Southwestern Medical Center1 product
- Mayo Clinic1 product
- The Methodist Hospital Research Institute1 product
- University of Wisconsin System1 product
- Washington University School of Medicine1 product
- The Johns Hopkins University1 product
- Precision Nuclear LLC1 product
- Kreitchman PET Center1 product
- The Feinstein Institutes for Medical Research1 product
- The Brigham and Women`s Hospital, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA022119 AMMONIA N 13 | Feinstein | August 23, 2007 | 1, latest January 5, 2011 2011: Labeling |
Generic approvals (18)
- ANDA203543Sofie · December 14, 2012
- ANDA203321Mcprf · February 25, 2013
- ANDA203700Cardinal Hlth 414 · February 25, 2013
- ANDA203938Kreitchman Pet Ctr · December 9, 2013
- ANDA204506Wa Univ Sch Med · February 7, 2014
- ANDA204496Ucsf Rodiopharm · March 28, 2014
- ANDA204514Johns Hopkins Univ · August 19, 2014
- ANDA204465Sofie · October 23, 2014
- ANDA203783Brigham Womens Hosp · October 30, 2014
- ANDA204352Biomedcl Res Fdn · May 1, 2015
- ANDA204547Precision Nuclear · August 14, 2015
- ANDA2037793d Imaging Drug · October 19, 2015
- ANDA204510Petnet · November 2, 2015
- ANDA207025Gen Hosp · February 3, 2016
- ANDA210524Ionetix · December 21, 2018
- ANDA209507Univ Tx Sw Medctr · November 1, 2019
- ANDA211740Univ Wisconsin · September 9, 2020
- ANDA215083Methodist · July 9, 2021
Shortage status
The FDA drug shortage list does not show these products.
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 label | c857724f-b172-4844-ad42-6fa4c42b0405 |
|---|---|
| FDA labels (SPL) | 14 |
| FDA applications | NDA022119, 18 ANDA |
| Active ingredients (FDA) | AMMONIA N-13 |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Ammonia N 13, The Feinstein Institutes for Medical Research, effective October 30, 2019; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- 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 →