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  5. NDC Package Code: 55301-916-00 Exchange Select Miconazole 1

NDC Package 55301-916-00 Exchange Select Miconazole 1

Miconazole Nitrate 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:
55301-916-00
Package Description:
1 KIT in 1 CARTON * 1 INSERT in 1 POUCH * 9 g in 1 TUBE
Product Code:
55301-916
Proprietary Name:
Exchange Select Miconazole 1
Non-Proprietary Name:
Miconazole Nitrate
Usage Information:
This medication is used to treat vaginal yeast infections. Miconazole 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 also 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:
55301091600
NDC to RxNorm Crosswalk:
  • RxCUI: 992774 - miconazole nitrate 1200 MG Vaginal Insert
  • RxCUI: 992774 - miconazole nitrate 1.2 GM Vaginal Insert
  • RxCUI: 992775 - {1 (miconazole nitrate 1200 MG Vaginal Insert) / 1 (9000 MG) (miconazole nitrate 20 MG/ML Vaginal Cream) } Pack
  • RxCUI: 992775 - miconazole 1 day - (1200 MG insert / 2 % cream 9 GM) Pack
  • RxCUI: 998483 - miconazole nitrate 2 % Topical Cream
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Army & Air Force Exchange Service
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    FDA Application Number:
    ANDA079114
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-25-2016
    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 55301-916-00?

    The NDC Packaged Code 55301-916-00 is assigned to a package of 1 kit in 1 carton * 1 insert in 1 pouch * 9 g in 1 tube of Exchange Select Miconazole 1, a human over the counter drug labeled by Army & Air Force Exchange Service. The product's dosage form is kit and is administered via form.

    Is NDC 55301-916 included in the NDC Directory?

    Yes, Exchange Select Miconazole 1 with product code 55301-916 is active and included in the NDC Directory. The product was first marketed by Army & Air Force Exchange Service on March 25, 2016 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 55301-916-00?

    The 11-digit format is 55301091600. 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
    5-3-255301-916-005-4-255301-0916-00