Fludeoxyglucose
NDC Package 49609-001-01

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 discontinued by the firm.

Fludeoxyglucose is a . Marketed by Sofie Co. Dba Sofie, this product is identified by NDC 49609-001 and is authorized under FDA application ANDA203665.

Identification & Billing

NDC Package Code
49609-001-01
Package Description
16 mL in 1 VIAL
Product Code
49609-001
11-Digit Billing Format
49609000101

Clinical Specifications

Proprietary Name
Fludeoxyglucose F18
Dosage Form
-

Regulatory & Marketing

Labeler Name
Sofie Co. Dba Sofie
FDA Application #
ANDA203665
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-08-2011
End Marketing Date
05-28-2024
Listing Expiration
05-28-2024
Exclude Flag
D
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 49609-001-01 identifies a specific commercial package of 16 ml in 1 vial of Fludeoxyglucose F18, labeled by Sofie Co. Dba Sofie. 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 Sofie Co. Dba Sofie on December 08, 2011. The current certification is valid through May 28, 2024.

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: 49609000101. 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)
49609-001-01
11-Digit CMS (5-4-2)
49609-0001-01

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