Fluocinolone Acetonide
NDC Package 68462-591-89

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 is a medication used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). Marketed by Glenmark Pharmaceuticals Inc., Usa, this product is identified by NDC 68462-591 and is authorized under FDA application ANDA210556.

Identification & Billing

NDC Package Code
68462-591-89
Package Description
1 BOTTLE in 1 CARTON / 118.28 mL in 1 BOTTLE
Product Code
68462-591
11-Digit Billing Format
68462059189
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Fluocinolone Acetonide
Dosage Form
-
Usage Information
This medication is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). Fluocinolone reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a medium-strength corticosteroid.

Regulatory & Marketing

Labeler Name
Glenmark Pharmaceuticals Inc., Usa
FDA Application #
ANDA210556
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-26-2018
End Marketing Date
05-01-2024
Listing Expiration
05-01-2024
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 68462-591-89 identifies a specific commercial package of 1 bottle in 1 carton / 118.28 ml in 1 bottle of Fluocinolone Acetonide, labeled by Glenmark Pharmaceuticals Inc., Usa. 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 Glenmark Pharmaceuticals Inc., Usa on October 26, 2018. The current certification is valid through May 01, 2024.

What are the primary indications for this medication?

This medication is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). Fluocinolone reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a medium-strength corticosteroid.

How is this Glenmark Pharmaceuticals Inc., Usa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68462059189. 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)
68462-591-89
11-Digit CMS (5-4-2)
68462-0591-89

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