Sodium Fluoride F 18
NDC Package 76419-211-25

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

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Sodium Fluoride F 18 is a . Marketed by Hot Shots Nm, Llc Dba Midwest Positron Technology, Lc, this product is identified by NDC 76419-211 and is authorized under FDA application ANDA204530.

Identification & Billing

NDC Package Code
76419-211-25
Package Description
25 mL in 1 VIAL, GLASS
Product Code
76419-211
11-Digit Billing Format
76419021125

Clinical Specifications

Proprietary Name
Sodium Fluoride F 18
Dosage Form
-

Regulatory & Marketing

Labeler Name
Hot Shots Nm, Llc Dba Midwest Positron Technology, Lc
FDA Application #
ANDA204530
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-21-2014
End Marketing Date
12-01-2021
Listing Expiration
12-01-2021
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (76419-211). Click a package code to view its specific billing and regulatory data.

76419-211-10
10 mL in 1 VIAL, GLASS
76419-211-30
30 mL in 1 VIAL, GLASS
76419-211-50
50 mL in 1 VIAL, GLASS

* 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 76419-211-25 identifies a specific commercial package of 25 ml in 1 vial, glass of Sodium Fluoride F 18, labeled by Hot Shots Nm, Llc Dba Midwest Positron Technology, Lc. 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 Hot Shots Nm, Llc Dba Midwest Positron Technology, Lc on August 21, 2014. The current certification is valid through December 01, 2021.

How is this Hot Shots Nm, Llc Dba Midwest Positron Technology, Lc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76419021125. 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)
76419-211-25
11-Digit CMS (5-4-2)
76419-0211-25

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