Fluorodopa Injection
NDC Package 13267-345-56

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

Package Information

Fluorodopa (fluorodopa f18) injection is fluorodopa F 18 Injection is indicated for use in positron emission tomography (PET) to visualize dopaminergic nerve terminals in the striatum for the evaluation of adult patients with suspected Parkinsonian syndromes (PS). This formulation utilizes a injection delivery system. Marketed by The Feinstein Institutes For Medical Research, this product is identified by NDC 13267-345 and is authorized under FDA application NDA200655.

Identification & Billing

NDC Package Code
13267-345-56
Package Description
25 mL in 1 VIAL, GLASS
Product Code
13267-345
11-Digit Billing Format
13267034556
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
Fluorodopa F18
Non-Proprietary Name
Fluorodopa F18
Substance Name
Fluorodopa 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)
FLUORODOPA F-18 8.33 mCi/mL
Usage Information
Fluorodopa F 18 Injection is indicated for use in positron emission tomography (PET) to visualize dopaminergic nerve terminals in the striatum for the evaluation of adult patients with suspected Parkinsonian syndromes (PS). Fluorodopa F 18 PET is an adjunct to other diagnostic evaluations.

Regulatory & Marketing

Labeler Name
The Feinstein Institutes For Medical Research
Product Type
Human Prescription Drug
FDA Application #
NDA200655
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-10-2019
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 13267-345-56 identifies a specific commercial package of 25 ml in 1 vial, glass of Fluorodopa F18, a human prescription drug labeled by The Feinstein Institutes For Medical Research. 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 fluorodopa 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 The Feinstein Institutes For Medical Research on October 10, 2019. The current certification is valid through December 31, 2026.

How is this The Feinstein Institutes For Medical Research product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 13267034556. 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)
13267-345-56
11-Digit CMS (5-4-2)
13267-0345-56

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