Fludeoxyglucose F 18 Injection
NDC Package 49609-101-01

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

Package Information

Fludeoxyglucose F 18 injection is fludeoxyglucose F18 Injection, USP is indicated for positron emission tomography (PET) imaging in the following settings:. This formulation utilizes a injection delivery system. Marketed by Sofie Co., this product is identified by NDC 49609-101 and is authorized under FDA application ANDA203591.

Identification & Billing

NDC Package Code
49609-101-01
Package Description
30 mL in 1 VIAL, MULTI-DOSE
Product Code
49609-101
11-Digit Billing Format
49609010101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Fludeoxyglucose F 18
Non-Proprietary Name
Fludeoxyglucose F-18
Substance Name
Fludeoxyglucose F-18
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)
FLUDEOXYGLUCOSE F-18 300 mCi/mL
Pharmacologic Class
Usage Information
Fludeoxyglucose F18 Injection, USP is indicated for positron emission tomography (PET) imaging in the following settings:

Regulatory & Marketing

Labeler Name
Sofie Co.
Product Type
Human Prescription Drug
FDA Application #
ANDA203591
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-08-2011
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (49609-101). Click a package code to view its specific billing and regulatory data.

49609-101-02
50 mL in 1 VIAL, MULTI-DOSE

* 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 49609-101-01 identifies a specific commercial package of 30 ml in 1 vial, multi-dose of Fludeoxyglucose F 18, a human prescription drug labeled by Sofie Co.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection is formulated for intravenous use and contains fludeoxyglucose f-18 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. on December 08, 2011. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49609010101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
49609-101-01
11-Digit CMS (5-4-2)
49609-0101-01

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