Florasone Cream
NDC Package 53499-0390-4

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

Package Information

Florasone (cardiospermum halicacabum flowering top) cream is temporarily relieves itch, rash and skin irritation/inflammation. This formulation utilizes a cream delivery system. Marketed by Schwabe North America, this product is identified by NDC 53499-0390.

Identification & Billing

NDC Package Code
53499-0390-4
Package Description
1 TUBE in 1 CARTON / 28 g in 1 TUBE
Product Code
53499-0390
11-Digit Billing Format
53499039004

Clinical Specifications

Proprietary Name
Florasone
Non-Proprietary Name
Cardiospermum Halicacabum Flowering Top
Substance Name
Cardiospermum Halicacabum Flowering Top
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)
CARDIOSPERMUM HALICACABUM FLOWERING TOP 1 [hp_X]/28g
Usage Information
Temporarily relieves itch, rash and skin irritation/inflammation.

Regulatory & Marketing

Labeler Name
Schwabe North America
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date
01-01-2006
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 53499-0390-4 identifies a specific commercial package of 1 tube in 1 carton / 28 g in 1 tube of Florasone, a human over the counter drug labeled by Schwabe North America. This cream is formulated for topical use and contains cardiospermum halicacabum flowering top 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 Schwabe North America on January 01, 2006. The current certification is valid through December 31, 2026.

How is this Schwabe North America product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53499039004. 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)
53499-0390-4
11-Digit CMS (5-4-2)
53499-0390-04

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