Ammonia N 13 Injection
NDC Package 40089-113-20

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 (nh3n13) injection is 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. This formulation utilizes a injection delivery system. Marketed by The Johns Hopkins University, this product is identified by NDC 40089-113 and is authorized under FDA application ANDA204514.

Identification & Billing

NDC Package Code
40089-113-20
Package Description
20 mL in 1 VIAL, GLASS
Product Code
40089-113
11-Digit Billing Format
40089011320

Clinical Specifications

Proprietary Name
Ammonia N 13
Non-Proprietary Name
Nh3n13
Substance Name
Ammonia N-13
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
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
The Johns Hopkins University
Product Type
Human Prescription Drug
FDA Application #
ANDA204514
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-21-2012
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 40089-113-20 identifies a specific commercial package of 20 ml in 1 vial, glass of Ammonia N 13, a human prescription drug labeled by The Johns Hopkins University. This injection 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 The Johns Hopkins University on March 21, 2012. The current certification is valid through December 31, 2026.

How is this The Johns Hopkins University product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 40089011320. 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)
40089-113-20
11-Digit CMS (5-4-2)
40089-0113-20

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