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  5. NDC Package Code: 49035-135-46 Miconazole Nitrate

NDC Package 49035-135-46 Miconazole Nitrate

Jock Itch Spray Aerosol, Spray 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:
49035-135-46
Package Description:
130 g in 1 PACKAGE
Product Code:
49035-135
Proprietary Name:
Miconazole Nitrate
Non-Proprietary Name:
Jock Itch Spray
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:
49035013546
Product Type:
Human Otc Drug
Labeler Name:
Wal-mart Stores, Inc.
Dosage Form:
Aerosol, Spray - An aerosol product which utilizes a compressed gas as the propellant to provide the force necessary to expel the product as a wet spray; it is applicable to solutions of medicinal agents in aqueous solvents.
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):
  • MICONAZOLE NITRATE 1.3 g/130g
    • 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:
    02-28-2019
    Listing Expiration Date:
    12-31-2025
    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 49035-135-46?

    The NDC Packaged Code 49035-135-46 is assigned to a package of 130 g in 1 package of Miconazole Nitrate, a human over the counter drug labeled by Wal-mart Stores, Inc.. The product's dosage form is aerosol, spray and is administered via topical form.

    Is NDC 49035-135 included in the NDC Directory?

    Yes, Miconazole Nitrate with product code 49035-135 is active and included in the NDC Directory. The product was first marketed by Wal-mart Stores, Inc. on February 28, 2019 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 49035-135-46?

    The 11-digit format is 49035013546. 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
    5-3-249035-135-465-4-249035-0135-46