Refissa
NDC 50224-002

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 50224-002?
  4. Refissa Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Patient Education

Product Information

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

Refissa is a ANDA-approved product labeled by Suneva Medical, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 50224-002 and 5 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
50224-002
Proprietary Name:
Refissa
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Suneva Medical, Inc.
Labeler Code:
50224
Product Label ID:
357ed7c9-6ffa-45b8-94be-4d440f5a1c22
FDA Application Number: [6]
ANDA076498
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
06-17-2009
Listing Expiration Date: [11]
12-31-2018
Exclude Flag: [12]
I

Code Structure Chart

Product Details

What is NDC 50224-002?

The NDC code 50224-002 is assigned by the FDA to the product Refissa. This pharmaceutical product is labeled by Suneva Medical, Inc. and is currently categorized as listed product. In terms of distribution, this product is available in 5 different package configurations. The associated package NDC(s) include: 50224-002-02, 50224-002-03, 50224-002-04, 50224-002-05, 50224-002-06. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

(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.)

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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Patient Education

Tretinoin Topical


Tretinoin (Altreno, Atralin, Avita, Retin-A) is used to treat acne. Tretinoin is also used to reduce fine wrinkles (Refissa and Renova) and to improve spotty discoloration (Renova) and rough feeling skin (Renova) when used along with other skin care and sunlight avoidance programs. Tretinoin is in a class of medications called retinoids. It works by promoting peeling of affected skin areas and unclogging pores.
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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".