NDC Package 50224-002-04 Refissa

View Billable Units, 11-Digit Format, RxNorm

Package Information
Other Packages
Frequently Asked Questions

Package Information

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

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

50224-002-04

Package Description:

60 g in 1 TUBE

Product Code:

50224-002

Proprietary Name:

Refissa

Usage Information:

(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.) Refissa [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 do not achieve such palliation using comprehensive skin care and sun avoidance programs (see bullet 3 for populations in which effectiveness has not been established). REFISSA DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE A MORE YOUTHFUL or YOUNGER DERMAL HISTOLOGIC PATTERN. Many patients achieve desired palliative effects on fine wrinkling, mottled hyperpigmentation, and tactile roughness of facial skin with the use of comprehensive skin care and sun avoidance programs including sunscreens, protective clothing, and emollient creams NOT containing tretinoin. Tretinoin Cream, USP (Emollient) 0.05% has demonstrated NO 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. Refissa should be used under medical supervision as an adjunct to a comprehensive skin care and sun 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 sun avoidance program alone.The effectiveness of Refissa [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 Refissa 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.)

11-Digit NDC Billing Format:

50224000204

Billing Unit:

GM - Billing unit of "gram" is used when a product is measured by its weight.

NDC to RxNorm Crosswalk:

60 GM

NDC to RxNorm Crosswalk:

RxCUI: 2117659 - tretinoin 0.05 % Emollient Base Topical Cream

RxCUI: 2117659 - Emollient tretinoin 0.5 MG/ML Topical Cream

RxCUI: 855687 - Refissa 0.05 % Topical Cream

RxCUI: 855687 - Emollient tretinoin 0.5 MG/ML Topical Cream [Refissa]

Labeler Name:

Suneva Medical, Inc.

Sample Package:

Start Marketing Date:

06-17-2009

Listing Expiration Date:

12-31-2018

Exclude Flag:

Code Structure:

50224 - Suneva Medical, Inc.
- 50224-002 - Refissa
  - 50224-002-04 - 60 g in 1 TUBE

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
50224-002-02	20 g in 1 TUBE
50224-002-03	40 g in 1 TUBE
50224-002-05	40 g in 1 TUBE
50224-002-06	20 g in 1 TUBE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 50224-002-04?

The NDC Packaged Code 50224-002-04 is assigned to a package of 60 g in 1 tube of Refissa, labeled by Suneva Medical, Inc.. The product's dosage form is and is administered via form.This product is billed per "GM" gram and contains an estimated amount of 60 billable units per package.

Is NDC 50224-002 included in the NDC Directory?

No, Refissa with product code 50224-002 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Suneva Medical, Inc. on June 17, 2009 and its listing in the NDC Directory is set to expire on December 31, 2018 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 50224-002-04?

The contents of this package are billed per "gm or gram", products billed per gram are products measured by weight. The calculated billable units for this package is 60.

What is the 11-digit format for NDC 50224-002-04?

The 11-digit format is 50224000204. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	50224-002-04	5-4-2	50224-0002-04

Table of Contents