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  5. NDC Package Code: 53002-8400-2 Clotrimazole

NDC Package 53002-8400-2 Clotrimazole

Solution 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:
53002-8400-2
Package Description:
1 BOTTLE, PLASTIC in 1 CARTON / 30 mL in 1 BOTTLE, PLASTIC
Product Code:
53002-8400
Proprietary Name:
Clotrimazole
Non-Proprietary Name:
Clotrimazole
Substance Name:
Clotrimazole
Usage Information:
Clotrimazole is used to treat skin infections such as athlete's foot, jock itch, ringworm, and other fungal skin infections (candidiasis). This medication is also used to treat a skin condition known as pityriasis (tinea versicolor), a fungal infection that causes a lightening or darkening of the skin of the neck, chest, arms, or legs. Clotrimazole is an azole antifungal that works by preventing the growth of fungus.
11-Digit NDC Billing Format:
53002840002
NDC to RxNorm Crosswalk:
  • RxCUI: 309370 - clotrimazole 1 % Topical Solution
  • RxCUI: 309370 - clotrimazole 10 MG/ML Topical Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Rpk Pharmaceuticals, Inc.
    Dosage Form:
    Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
    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):
  • CLOTRIMAZOLE 10 mg/mL
    • Pharmacologic Class(es):
  • Azole Antifungal - [EPC] (Established Pharmacologic Class)
  • Azoles - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA074580
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-29-1996
    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.

    Frequently Asked Questions

    What is NDC 53002-8400-2?

    The NDC Packaged Code 53002-8400-2 is assigned to a package of 1 bottle, plastic in 1 carton / 30 ml in 1 bottle, plastic of Clotrimazole, a human prescription drug labeled by Rpk Pharmaceuticals, Inc.. The product's dosage form is solution and is administered via topical form.

    Is NDC 53002-8400 included in the NDC Directory?

    Yes, Clotrimazole with product code 53002-8400 is active and included in the NDC Directory. The product was first marketed by Rpk Pharmaceuticals, Inc. on July 29, 1996 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 11-digit format for NDC 53002-8400-2?

    The 11-digit format is 53002840002. 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 5-4-1 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
    5-4-153002-8400-25-4-253002-8400-02