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  5. NDC Package Code: 59088-778-00 Miconatate

NDC Package 59088-778-00 Miconatate

Miconazole Nitrate And Tolnaftate Kit - 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:
59088-778-00
Package Description:
1 KIT in 1 CARTON * 30 mL in 1 BOTTLE, WITH APPLICATOR (59088-443-03) * 85 g in 1 BOTTLE (59088-442-07)
Product Code:
59088-778
Proprietary Name:
Miconatate
Non-Proprietary Name:
Miconazole Nitrate And Tolnaftate
Usage Information:
clean the affected area and dry thoroughly apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor supervise children in the use of this product for athlete's foot, pay special attention to spaces between the toes, wear well-fitting, ventilated shoes, and change shoes and socks at least once daily for athlete's foot and ringworm, use daily for 4 weeks for jock itch, use daily for 2 weeks if condition persists longer, consult a doctor. This product is not effective on the scalp or nails. clean the affected area and dry thoroughlyapply a thin layer of the product over affected area twice daily (morning and night) paying special attention to the edges of the nail, cuticles, and skin around the nails or as directed by a doctorsupervise children in the use of this productfor athlete's foot, pay special attention to spaces between the toes, wear well-fitting, ventilated shoes, and change shoes and socks at least once dailyfor athlete's foot and ringworm, use daily for 4 weeksif condition persists longer, consult a doctor.Use under the direction of a medical practitioner
11-Digit NDC Billing Format:
59088077800
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
  • RxCUI: 313423 - tolnaftate 1 % Topical Solution
  • RxCUI: 313423 - tolnaftate 10 MG/ML Topical Solution
  • RxCUI: 998461 - miconazole nitrate 2 % Topical Powder
  • RxCUI: 998461 - miconazole nitrate 0.02 MG/MG Topical Powder
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Puretek Corporation
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    FDA Application Number:
    part333C
    Marketing Category:
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date:
    09-02-2021
    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 59088-778-00?

    The NDC Packaged Code 59088-778-00 is assigned to a package of 1 kit in 1 carton * 30 ml in 1 bottle, with applicator (59088-443-03) * 85 g in 1 bottle (59088-442-07) of Miconatate, a human over the counter drug labeled by Puretek Corporation. The product's dosage form is kit and is administered via form.

    Is NDC 59088-778 included in the NDC Directory?

    Yes, Miconatate with product code 59088-778 is active and included in the NDC Directory. The product was first marketed by Puretek Corporation on September 02, 2021 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 59088-778-00?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units.

    What is the 11-digit format for NDC 59088-778-00?

    The 11-digit format is 59088077800. 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
    5-3-259088-778-005-4-259088-0778-00