1. Home
  2. Labeler Index
  3. Padagis Israel Pharmaceuticals Ltd
  4. 45802-846
  5. NDC Package Code: 45802-846-01 Adapalene And Benzoyl Peroxide

NDC Package 45802-846-01 Adapalene And Benzoyl Peroxide

Gel Topical - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

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:
45802-846-01
Package Description:
45 g in 1 BOTTLE, PUMP
Product Code:
45802-846
Proprietary Name:
Adapalene And Benzoyl Peroxide
Non-Proprietary Name:
Adapalene And Benzoyl Peroxide
Substance Name:
Adapalene; Benzoyl Peroxide
Usage Information:
Adapalene and Benzoyl Peroxide Gel, 0.1%/2.5% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.
11-Digit NDC Billing Format:
45802084601
Billing Unit:
GM - Billing unit of "gram" is used when a product is measured by its weight.
NDC to RxNorm Crosswalk:
45 GM
NDC to RxNorm Crosswalk:
  • RxCUI: 829539 - adapalene 0.1 % / benzoyl peroxide 2.5 % Topical Gel
  • RxCUI: 829539 - adapalene 0.001 MG/MG / benzoyl peroxide 0.025 MG/MG Topical Gel
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Padagis Israel Pharmaceuticals Ltd
    Dosage Form:
    Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
    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):
  • ADAPALENE .1 g/100g
  • BENZOYL PEROXIDE 2.5 g/100g
    • Pharmacologic Class(es):
  • Retinoid - [EPC] (Established Pharmacologic Class)
  • Retinoids - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA205033
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-24-2018
    Listing Expiration Date:
    12-31-2025
    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.

    Frequently Asked Questions

    What is NDC 45802-846-01?

    The NDC Packaged Code 45802-846-01 is assigned to a package of 45 g in 1 bottle, pump of Adapalene And Benzoyl Peroxide, a human prescription drug labeled by Padagis Israel Pharmaceuticals Ltd. The product's dosage form is gel and is administered via topical form.

    Is NDC 45802-846 included in the NDC Directory?

    Yes, Adapalene And Benzoyl Peroxide with product code 45802-846 is active and included in the NDC Directory. The product was first marketed by Padagis Israel Pharmaceuticals Ltd on January 24, 2018 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 45802-846-01?

    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 45.

    What is the 11-digit format for NDC 45802-846-01?

    The 11-digit format is 45802084601. 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
    5-3-245802-846-015-4-245802-0846-01