Fluocinonide Cream
NDC Package 68071-4921-5

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

Package Information

Fluocinonide cream is a medication used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). This formulation utilizes a cream delivery system. Marketed by Nucare Pharmaceuticals,inc., this product is identified by NDC 68071-4921 and is authorized under FDA application ANDA071500.

Identification & Billing

NDC Package Code
68071-4921-5
Package Description
30 g in 1 TUBE
Product Code
68071-4921
11-Digit Billing Format
68071492105
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Fluocinonide
Non-Proprietary Name
Fluocinonide
Substance Name
Fluocinonide
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
FLUOCINONIDE .5 mg/g
Pharmacologic Class
Usage Information
This medication is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). Fluocinonide reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a strong corticosteroid.

Regulatory & Marketing

Labeler Name
Nucare Pharmaceuticals,inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA071500
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-27-2016
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 68071-4921-5 identifies a specific commercial package of 30 g in 1 tube of Fluocinonide, a human prescription drug labeled by Nucare Pharmaceuticals,inc.. This cream is formulated for topical use and contains fluocinonide 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 Nucare Pharmaceuticals,inc. on October 27, 2016. The current certification is valid through December 31, 2026.

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). Fluocinonide reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a strong corticosteroid.

How is this Nucare Pharmaceuticals,inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071492105. 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 (5-4-1)
68071-4921-5
11-Digit CMS (5-4-2)
68071-4921-05

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