Ammonia N 13 Injection, Solution
NDC Package 52670-552-30

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

Package Information

Ammonia N 13 injection is uSP 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 formulation utilizes a injection, solution delivery system. Marketed by Mayo Clinic, this product is identified by NDC 52670-552 and is authorized under FDA application ANDA203321.

Identification & Billing

NDC Package Code
52670-552-30
Package Description
30 mL in 1 VIAL, SINGLE-DOSE
Product Code
52670-552
11-Digit Billing Format
52670055230

Clinical Specifications

Proprietary Name
Ammonia N 13
Non-Proprietary Name
Ammonia N-13
Substance Name
Ammonia N-13
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
AMMONIA N-13 37.5 mCi/mL
Pharmacologic Class
Usage Information
Ammonia N 13 Injection USP 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.

Regulatory & Marketing

Labeler Name
Mayo Clinic
Product Type
Human Prescription Drug
FDA Application #
ANDA203321
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-25-2013
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 52670-552-30 identifies a specific commercial package of 30 ml in 1 vial, single-dose of Ammonia N 13, a human prescription drug labeled by Mayo Clinic. This injection, solution is formulated for intravenous use and contains ammonia n-13 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 February 25, 2013. 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: 52670055230. 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)
52670-552-30
11-Digit CMS (5-4-2)
52670-0552-30

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