Ammonian 13
NDC Package 76167-003-30

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Ammonian 13 is 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. Marketed by Children's Hospital Of Michigan, this product is identified by NDC 76167-003.

Identification & Billing

NDC Package Code
76167-003-30
Package Description
30 mL in 1 VIAL
Product Code
76167-003
11-Digit Billing Format
76167000330

Clinical Specifications

Proprietary Name
Ammonian 13 N 13
Dosage Form
-
Usage Information
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.

Regulatory & Marketing

Labeler Name
Children's Hospital Of Michigan
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
01-30-2012
Listing Expiration
12-31-2017
Exclude Flag
I
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 76167-003-30 identifies a specific commercial package of 30 ml in 1 vial of Ammonian 13 N 13, labeled by Children's Hospital Of Michigan. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Children's Hospital Of Michigan on January 30, 2012. The current certification is valid through December 31, 2017.

How is this Children's Hospital Of Michigan product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76167000330. 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)
76167-003-30
11-Digit CMS (5-4-2)
76167-0003-30

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