NDC Package 59088-210-16 Urea 39.5% With 2% Salicylic Acid

Urea,Salicylic Acid Cream Topical - View Billable Units, 11-Digit Format, RxNorm

Package Information

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:
59088-210-16
Package Description:
227 g in 1 JAR
Product Code:
Proprietary Name:
Urea 39.5% With 2% Salicylic Acid
Non-Proprietary Name:
Urea, Salicylic Acid
Substance Name:
Salicylic Acid; Urea
Usage Information:
For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eshar. Urea is useful for the treatment of hyperkeratotic conditions such as dermatitis, psoriasis, soothes rough and dry skin, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.
11-Digit NDC Billing Format:
59088021016
Billing Unit:
GM - Billing unit of "gram" is used when a product is measured by its weight.
NDC to RxNorm Crosswalk:
227 GM
NDC to RxNorm Crosswalk:
  • RxCUI: 2632843 - salicylic acid 2 % / urea 39.5 % Topical Cream
  • RxCUI: 2632843 - salicylic acid 20 MG/ML / urea 395 MG/ML Topical Cream
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Puretek Corporation
    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(s):
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Sample Package:
    No
    Marketing Category:
    UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
    Start Marketing Date:
    03-24-2023
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N

    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.

    Frequently Asked Questions

    What is NDC 59088-210-16?

    The NDC Packaged Code 59088-210-16 is assigned to a package of 227 g in 1 jar of Urea 39.5% With 2% Salicylic Acid, a human prescription drug labeled by Puretek Corporation. The product's dosage form is cream and is administered via topical form.This product is billed per "GM" gram and contains an estimated amount of 227 billable units per package.

    Is NDC 59088-210 included in the NDC Directory?

    Yes, Urea 39.5% With 2% Salicylic Acid with product code 59088-210 is active and included in the NDC Directory. The product was first marketed by Puretek Corporation on March 24, 2023 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 59088-210-16?

    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 227.

    What is the 11-digit format for NDC 59088-210-16?

    The 11-digit format is 59088021016. 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 Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-259088-210-165-4-259088-0210-16