Flac Otic Oil
NDC Package 39328-079-20

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

Package Information

Flac Otic Oil (fluocinolone acetonide) oils is a medication used to treat eczema of the outer ear (also known as chronic itchy ear). This formulation utilizes a oil delivery system. Marketed by Patrin Pharma, Inc., this product is identified by NDC 39328-079 and is authorized under FDA application ANDA210736.

Identification & Billing

NDC Package Code
39328-079-20
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 20 mL in 1 BOTTLE, DROPPER
Product Code
39328-079
11-Digit Billing Format
39328007920
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Flac Otic Oil
Non-Proprietary Name
Fluocinolone Acetonide
Substance Name
Fluocinolone Acetonide
Dosage Form
Oil - An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils.
Administration Route
Auricular (otic) - Administration to or by way of the ear.
Active Ingredient(s)
FLUOCINOLONE ACETONIDE .11 mg/mL
Pharmacologic Class
Usage Information
This medication is used to treat eczema of the outer ear (also known as chronic itchy ear). The main symptom is itchiness, but redness, flaking, or oozing may also occur. Fluocinolone reduces these symptoms. This medication is a low- to medium-strength corticosteroid.

Regulatory & Marketing

Labeler Name
Patrin Pharma, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA210736
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-12-2018
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 39328-079-20 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 20 ml in 1 bottle, dropper of Flac Otic Oil, a human prescription drug labeled by Patrin Pharma, Inc.. This oil is formulated for auricular (otic) use and contains fluocinolone acetonide 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 Patrin Pharma, Inc. on April 12, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat eczema of the outer ear (also known as chronic itchy ear). The main symptom is itchiness, but redness, flaking, or oozing may also occur. Fluocinolone reduces these symptoms. This medication is a low- to medium-strength corticosteroid.

How is this Patrin Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 39328007920. 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)
39328-079-20
11-Digit CMS (5-4-2)
39328-0079-20

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