Renova
NDC Package 42254-165-40

11-digit billing NDC: 42254016540 · Billing unit: GM · 40 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.

Renova is (To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.)RENOVA® (tretinoin cream) 0.02% is indicated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine facial wrinkles in patients who use comprehensive skin care and sunlight avoidance programs. Marketed by Rebel Distributors Corp, this product is identified by NDC 42254-165 and is authorized under FDA application NDA021108.

Identification & Billing

NDC Package Code
42254-165-40
Package Description
1 TUBE in 1 CARTON / 40 g in 1 TUBE
Product Code
42254-165
11-Digit Billing Format
42254016540
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
Renova
Dosage Form
-
Usage Information
(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.)RENOVA® (tretinoin cream) 0.02% is indicated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine facial wrinkles in patients who use comprehensive skin care and sunlight avoidance programs. RENOVA® (tretinoin cream) 0.02% 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 of facial skin with the use of comprehensive skin care and sunlight avoidance programs including sunscreens, protective clothing, and non-prescription emollient creams.RENOVA® (tretinoin cream) 0.02% has NOT DEMONSTRATED A MITIGATING EFFECT on significant signs of chronic sunlight exposure such as coarse or deep wrinkling, tactile roughness, mottled hyperpigmentation, lentigines, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis.RENOVA® (tretinoin cream) 0.02% 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.Patients with visible actinic keratoses and patients with a history of skin cancer were excluded from clinical trials of RENOVA® (tretinoin cream) 0.02%. Thus the effectiveness and safety of RENOVA® (tretinoin cream) 0.02% in these populations are not known at this time.Neither the safety nor the effectiveness of RENOVA® (tretinoin cream) 0.02% for the prevention or treatment of actinic keratoses or skin neoplasms has been established.Neither the safety nor the efficacy of RENOVA® (tretinoin cream) 0.02% daily for greater than 52 weeks has been established, and daily use beyond 52 weeks has not been systematically and histologically investigated in adequate and well-controlled trials. (See WARNINGS section.)

Regulatory & Marketing

Labeler Name
Rebel Distributors Corp
FDA Application #
NDA021108
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-18-2011
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 42254-165-40 identifies a specific commercial package of 1 tube in 1 carton / 40 g in 1 tube of Renova, labeled by Rebel Distributors Corp. 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 Rebel Distributors Corp on October 18, 2011. The current certification is valid through December 31, 2017.

How is this Rebel Distributors Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42254016540. 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)
42254-165-40
11-Digit CMS (5-4-2)
42254-0165-40

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