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  5. NDC Package Code: 11509-0825-1 Vagisil Brand Vagistat

NDC Package 11509-0825-1 Vagisil Brand Vagistat

Miconazole Nitrate 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:
11509-0825-1
Package Description:
1 TUBE in 1 CARTON / 45 g in 1 TUBE
Product Code:
11509-0825
Proprietary Name:
Vagisil Brand Vagistat
Non-Proprietary Name:
Miconazole Nitrate
Substance 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:
11509082501
NDC to RxNorm Crosswalk:
  • RxCUI: 1359442 - Vagistat 2 % Vaginal Cream
  • RxCUI: 1359442 - miconazole nitrate 20 MG/ML Vaginal Cream [Vagistat]
  • RxCUI: 1359442 - Vagistat-3 2 % Vaginal Cream
  • RxCUI: 998540 - miconazole nitrate 2 % Vaginal Cream
  • RxCUI: 998540 - miconazole nitrate 20 MG/ML Vaginal Cream
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Combe Incorporated
    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):
  • MICONAZOLE NITRATE 2 g/100g
    • Pharmacologic Class(es):
  • Azole Antifungal - [EPC] (Established Pharmacologic Class)
  • Azoles - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA074760
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-08-2020
    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 11509-0825-1?

    The NDC Packaged Code 11509-0825-1 is assigned to a package of 1 tube in 1 carton / 45 g in 1 tube of Vagisil Brand Vagistat, a human over the counter drug labeled by Combe Incorporated. The product's dosage form is cream and is administered via vaginal form.

    Is NDC 11509-0825 included in the NDC Directory?

    Yes, Vagisil Brand Vagistat with product code 11509-0825 is active and included in the NDC Directory. The product was first marketed by Combe Incorporated on October 08, 2020 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 11509-0825-1?

    The 11-digit format is 11509082501. 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
    5-4-111509-0825-15-4-211509-0825-01