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  5. NDC Package Code: 80684-039-01 Thera Plus Antifungal Clotrimazole

NDC Package 80684-039-01 Thera Plus Antifungal Clotrimazole

Clotrimazole Cream 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:
80684-039-01
Package Description:
1 TUBE in 1 BOX / 14 g in 1 TUBE
Product Code:
80684-039
Proprietary Name:
Thera Plus Antifungal Clotrimazole
Non-Proprietary Name:
Clotrimazole
Substance Name:
Clotrimazole
Usage Information:
This medication is used to treat vaginal yeast infections. Clotrimazole reduces vaginal burning, itching, and discharge that may occur with this condition. This medication is an azole antifungal. It works by stopping the growth of yeast (fungus) that causes the infection. The vaginal product comes in 2 forms (a vaginal cream or tablet). Some products come with a skin cream to be applied to the area around the outside of the vagina. Ask your doctor before using this medication for self-treatment if this is your first vaginal infection. This medication only works for vaginal fungal infections. You may have a different type of infection (such as bacterial vaginosis) and may need a different medication. If you have fever, chills, flu-like symptoms, stomach/abdominal pain, or a bad-smelling vaginal discharge, do not use this medication. Contact your doctor right away because these may be signs of a more serious infection.
11-Digit NDC Billing Format:
80684003901
NDC to RxNorm Crosswalk:
  • RxCUI: 309367 - clotrimazole 1 % Topical Cream
  • RxCUI: 309367 - clotrimazole 10 MG/ML Topical Cream
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Fourstar Group Usa, 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):
  • CLOTRIMAZOLE 10 mg/g
    • Pharmacologic Class(es):
  • Azole Antifungal - [EPC] (Established Pharmacologic Class)
  • Azoles - [CS]
    • Sample Package:
    No
    FDA Application Number:
    M005
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    01-30-2022
    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 80684-039-01?

    The NDC Packaged Code 80684-039-01 is assigned to a package of 1 tube in 1 box / 14 g in 1 tube of Thera Plus Antifungal Clotrimazole, a human over the counter drug labeled by Fourstar Group Usa, Inc.. The product's dosage form is cream and is administered via topical form.

    Is NDC 80684-039 included in the NDC Directory?

    Yes, Thera Plus Antifungal Clotrimazole with product code 80684-039 is active and included in the NDC Directory. The product was first marketed by Fourstar Group Usa, Inc. on January 30, 2022 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 80684-039-01?

    The 11-digit format is 80684003901. 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
    5-3-280684-039-015-4-280684-0039-01