Refissa
NDC Package 50224-002-03

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Refissa is (To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.)Tretinoin Cream, USP (Emollient) 0.05% is indicated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin in patients who use comprehensive skin care and sunlight avoidance programs (see bullet 3 for populations in which effectiveness has not been established). Marketed by Suneva Medical, Inc., this product is identified by NDC 50224-002 and is authorized under FDA application ANDA076498.

Identification & Billing

NDC Package Code
50224-002-03
Package Description
40 g in 1 TUBE
Product Code
50224-002
11-Digit Billing Format
50224000203
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
40 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Refissa
Dosage Form
-
Usage Information
(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.)Tretinoin Cream, USP (Emollient) 0.05% is indicated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin in patients who use comprehensive skin care and sunlight avoidance programs (see bullet 3 for populations in which effectiveness has not been established). TRETINOIN CREAM, USP (EMOLLIENT) DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE MORE YOUTHFUL or YOUNGER SKIN. In double-blinded, vehicle-controlled clinical studies, many patients in the vehicle group achieved desired palliative effects on fine wrinkling, mottled hyperpigmentation, and tactile roughness of facial skin with the use of comprehensive skin care and sunlight avoidance programs including sunscreens, protective clothing, and non-prescription emollient creams.Tretinoin Cream, USP (Emollient) 0.05% has NOT DEMONSTRATED A MITIGATING EFFECT on significant signs of chronic sun exposure such as coarse or deep wrinkling, skin yellowing, lentigines, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis.Tretinoin Cream, USP (Emollient) 0.05% should be used under medical supervision as an adjunct to a comprehensive skin care and sunlight avoidance program that includes the use of effective sunscreens (minimum SPF of 15) and protective clothing when desired results on fine wrinkles, mottled hyperpigmentation, and roughness of facial skin have not been achieved with a comprehensive skin care and sunlight avoidance program alone.The effectiveness of Tretinoin Cream, USP (Emollient) 0.05% in the mitigation of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin has not been established in people greater than 50 years of age OR in people with moderately to heavily pigmented skin. In addition, patients with visible actinic keratoses and patients with a history of skin cancer were excluded from clinical trials of Tretinoin Cream, USP (Emollient) 0.05%. Thus the effectiveness and safety of Tretinoin Cream, USP (Emollient) 0.05% in these populations are not known at this time.Neither the safety nor the effectiveness of Tretinoin Cream, USP (Emollient) for the prevention or treatment of actinic keratoses or skin neoplasms has been established.Neither the safety nor the efficacy of using Tretinoin Cream, USP (Emollient) 0.05% daily for greater than 48 weeks has been established, and daily use beyond 48 weeks has not been systematically and histologically investigated in adequate and well-controlled trials. (see WARNINGS section.)

Regulatory & Marketing

Labeler Name
Suneva Medical, Inc.
FDA Application #
ANDA076498
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-17-2009
Listing Expiration
12-31-2018
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (50224-002). Click a package code to view its specific billing and regulatory data.

50224-002-02
20 g in 1 TUBE
50224-002-04
60 g in 1 TUBE
50224-002-05
40 g in 1 TUBE
50224-002-06
20 g in 1 TUBE

* 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 50224-002-03 identifies a specific commercial package of 40 g in 1 tube of Refissa, labeled by Suneva Medical, Inc.. This product is billed per "GM" gram and contains an estimated amount of 40 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 Suneva Medical, Inc. on June 17, 2009. The current certification is valid through December 31, 2018.

How is this Suneva Medical, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50224000203. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 40 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 (5-3-2)
50224-002-03
11-Digit CMS (5-4-2)
50224-0002-03

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