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  5. NDC Package Code: 68016-414-00 Clotrimazole

NDC Package 68016-414-00 Clotrimazole

Cream Vaginal - 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:
68016-414-00
Package Description:
1 TUBE in 1 CARTON / 45 g in 1 TUBE
Product Code:
68016-414
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:
68016041400
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: 309368 - clotrimazole 1 % Vaginal Cream
  • RxCUI: 309368 - clotrimazole 10 MG/ML Vaginal Cream
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Chain Drug Consortium, Llc
    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):
  • Vaginal - Administration into the vagina.
    • Active Ingredient(s):
  • CLOTRIMAZOLE 10 mg/g
    • Pharmacologic Class(es):
  • Azole Antifungal - [EPC] (Established Pharmacologic Class)
  • Azoles - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA074165
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-09-2013
    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 68016-414-00?

    The NDC Packaged Code 68016-414-00 is assigned to a package of 1 tube in 1 carton / 45 g in 1 tube of Clotrimazole, a human over the counter drug labeled by Chain Drug Consortium, Llc. The product's dosage form is cream and is administered via vaginal form.This product is billed per "GM" gram and contains an estimated amount of 45 billable units per package.

    Is NDC 68016-414 included in the NDC Directory?

    Yes, Clotrimazole with product code 68016-414 is active and included in the NDC Directory. The product was first marketed by Chain Drug Consortium, Llc on October 09, 2013 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 68016-414-00?

    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 68016-414-00?

    The 11-digit format is 68016041400. 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
    5-3-268016-414-005-4-268016-0414-00