Ammonia Injection
NDC Package 49609-003-01

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

Package Information

Ammonia (ammonia n-13) injection 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. This formulation utilizes a injection delivery system. Marketed by Sofie Co. Dba Sofie, this product is identified by NDC 49609-003 and is authorized under FDA application ANDA203543.

Identification & Billing

NDC Package Code
49609-003-01
Package Description
30 mL in 1 VIAL, GLASS
Product Code
49609-003
11-Digit Billing Format
49609000301

Clinical Specifications

Proprietary Name
Ammonia N 13
Non-Proprietary Name
Ammonia N-13
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-13 260 mCi/mL
Pharmacologic Class
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
Sofie Co. Dba Sofie
Product Type
Human Prescription Drug
FDA Application #
ANDA203543
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-04-2011
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 49609-003-01 identifies a specific commercial package of 30 ml in 1 vial, glass of Ammonia N 13, a human prescription drug labeled by Sofie Co. Dba Sofie. 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 Sofie Co. Dba Sofie on August 04, 2011. The current certification is valid through December 31, 2026.

How is this Sofie Co. Dba Sofie product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49609000301. 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)
49609-003-01
11-Digit CMS (5-4-2)
49609-0003-01

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