NDC Package 41520-616-00 Careone Miconazole 1

Miconazole Nitrate Kit - View Billable Units, 11-Digit Format, RxNorm

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:
41520-616-00
Package Description:
1 KIT in 1 CARTON * 1 SUPPOSITORY in 1 POUCH * 9 g in 1 TUBE
Product Code:
Proprietary Name:
Careone 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:
41520061600
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:
    American Sales Company
    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:
    01-15-2020
    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 41520-616-00?

    The NDC Packaged Code 41520-616-00 is assigned to a package of 1 kit in 1 carton * 1 suppository in 1 pouch * 9 g in 1 tube of Careone Miconazole 1, a human over the counter drug labeled by American Sales Company. The product's dosage form is kit and is administered via form.

    Is NDC 41520-616 included in the NDC Directory?

    Yes, Careone Miconazole 1 with product code 41520-616 is active and included in the NDC Directory. The product was first marketed by American Sales Company on January 15, 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 41520-616-00?

    The 11-digit format is 41520061600. 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
    5-3-241520-616-005-4-241520-0616-00