Vanos
NDC Package 54868-6204-0

11-digit billing NDC: 54868620400 · Billing unit: GM · 60 GM per package
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 inactivated by the FDA.

Vanos is (fluocinonide) Cream, 0.1%, is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older (See PRECAUTIONS: Pediatric Use).Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g/week because the safety of VANOS Cream for longer than 2 weeks has not been established and because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-6204 and is authorized under FDA application NDA021758.

Identification & Billing

NDC Package Code
54868-6204-0
Package Description
1 TUBE in 1 CARTON / 60 g in 1 TUBE
Product Code
54868-6204
11-Digit Billing Format
54868620400
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
60 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Vanos
Dosage Form
-
Usage Information
VANOS (fluocinonide) Cream, 0.1%, is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older (See PRECAUTIONS: Pediatric Use).Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g/week because the safety of VANOS Cream for longer than 2 weeks has not been established and because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Therapy should be discontinued when control of the disease is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Do not use more than half of the 120 g tube per week.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA021758
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-30-2010
Listing Expiration
12-31-2017
Exclude Flag
I
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 54868-6204-0 identifies a specific commercial package of 1 tube in 1 carton / 60 g in 1 tube of Vanos, labeled by Physicians Total Care, Inc.. This product is billed per "GM" gram and contains an estimated amount of 60 billable units per package. 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 Physicians Total Care, Inc. on November 30, 2010. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868620400. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 60 total billable units per package. 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)
54868-6204-0
11-Digit CMS (5-4-2)
54868-6204-00

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