Fluorescein Injection
NDC Package 14789-122-05

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

Package Information

Fluorescein injection is fluoresecin Injection 10%, , (100 mg/mL) and Fluorescein Injection 25% (250 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. This formulation utilizes a injection delivery system. Marketed by Nexus Pharmaceuticals Llc, this product is identified by NDC 14789-122 and is authorized under FDA application ANDA215709.

Identification & Billing

NDC Package Code
14789-122-05
Package Description
10 VIAL in 1 CARTON / 5 mL in 1 VIAL (14789-122-07)
Product Code
14789-122
11-Digit Billing Format
14789012205
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Fluorescein
Non-Proprietary Name
Fluorescein
Substance Name
Fluorescein
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)
FLUORESCEIN 500 mg/mL
Pharmacologic Class
Usage Information
Fluoresecin Injection 10%, , (100 mg/mL) and Fluorescein Injection 25% (250 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.

Regulatory & Marketing

Labeler Name
Nexus Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA215709
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-24-2023
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 14789-122-05 identifies a specific commercial package of 10 vial in 1 carton / 5 ml in 1 vial (14789-122-07) of Fluorescein, a human prescription drug labeled by Nexus Pharmaceuticals Llc. This injection is formulated for intravenous use and contains fluorescein 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 Nexus Pharmaceuticals Llc on October 24, 2023. The current certification is valid through December 31, 2026.

How is this Nexus Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 14789012205. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
14789-122-05
11-Digit CMS (5-4-2)
14789-0122-05

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