NDC Package 68134-801-01 Urea

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:
68134-801-01
Package Description:
1 BOTTLE, PLASTIC in 1 CARTON / 28.35 g in 1 BOTTLE, PLASTIC
Product Code:
Proprietary Name:
Urea
Non-Proprietary Name:
Urea
Substance Name:
Urea
Usage Information:
Urea is used to treat dry/rough skin conditions (e.g., eczema, psoriasis, corns, callus) and some nail problems (e.g., ingrown nails). It may also be used to help remove dead tissue in some wounds to help wound healing. Urea is known as a keratolytic. It increases moisture in the skin by softening/dissolving the horny substance (keratin) holding the top layer of skin cells together. This effect helps the dead skin cells fall off and helps the skin keep more water in.
11-Digit NDC Billing Format:
68134080101
Billing Unit:
GM - Billing unit of "gram" is used when a product is measured by its weight.
NDC to RxNorm Crosswalk:
28.35 GM
NDC to RxNorm Crosswalk:
  • RxCUI: 198342 - urea 40 % Topical Cream
  • RxCUI: 198342 - urea 400 MG/ML Topical Cream
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Palmetto Pharmaceuticals Inc.
    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.
  • Active Ingredient(s):
    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:
    02-24-2023
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 CodePackage Description
    68134-801-0385 g in 1 BOTTLE, PLASTIC
    68134-801-07198.4 g in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 68134-801-01?

    The NDC Packaged Code 68134-801-01 is assigned to a package of 1 bottle, plastic in 1 carton / 28.35 g in 1 bottle, plastic of Urea, a human prescription drug labeled by Palmetto Pharmaceuticals Inc.. 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 28.35 billable units per package.

    Is NDC 68134-801 included in the NDC Directory?

    Yes, Urea with product code 68134-801 is active and included in the NDC Directory. The product was first marketed by Palmetto Pharmaceuticals Inc. on February 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 68134-801-01?

    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 28.35.

    What is the 11-digit format for NDC 68134-801-01?

    The 11-digit format is 68134080101. 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
    5-3-268134-801-015-4-268134-0801-01