Fluocinolone Acetonide 0.01%
NDC Package 13925-508-20

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.

Fluocinolone Acetonide 0.01% is a . Marketed by Seton Pharmaceuticals, this product is identified by NDC 13925-508 and is authorized under FDA application NDA019452.

Identification & Billing

NDC Package Code
13925-508-20
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 20 mL in 1 BOTTLE, DROPPER
Product Code
13925-508
11-Digit Billing Format
13925050820
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Fluocinolone Acetonide 0.01%
Dosage Form
-

Regulatory & Marketing

Labeler Name
Seton Pharmaceuticals
FDA Application #
NDA019452
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
08-01-2013
End Marketing Date
04-30-2018
Listing Expiration
04-30-2018
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 13925-508-20 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 20 ml in 1 bottle, dropper of Fluocinolone Acetonide 0.01%, labeled by Seton Pharmaceuticals. 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 Seton Pharmaceuticals on August 01, 2013. The current certification is valid through April 30, 2018.

How is this Seton Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 13925050820. 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)
13925-508-20
11-Digit CMS (5-4-2)
13925-0508-20

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