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  5. NDC Package Code: 53002-7341-1 Vandazole

NDC Package 53002-7341-1 Vandazole

Metronidazole Gel 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:
53002-7341-1
Package Description:
1 TUBE, WITH APPLICATOR in 1 CARTON / 70 g in 1 TUBE, WITH APPLICATOR
Product Code:
53002-7341
Proprietary Name:
Vandazole
Non-Proprietary Name:
Metronidazole
Substance Name:
Metronidazole
Usage Information:
This medication is used to treat certain types of bacterial infections in the vagina. Metronidazole is an antibiotic that works by stopping the growth of bacteria.
11-Digit NDC Billing Format:
53002734101
Product Type:
Human Prescription Drug
Labeler Name:
Rpk Pharmaceuticals, Inc.
Dosage Form:
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route(s):
  • Vaginal - Administration into the vagina.
    • Active Ingredient(s):
  • METRONIDAZOLE 7.5 mg/g
    • Pharmacologic Class(es):
  • Nitroimidazole Antimicrobial - [EPC] (Established Pharmacologic Class)
  • Nitroimidazoles - [CS]
    • Sample Package:
    No
    FDA Application Number:
    NDA021806
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    10-04-2005
    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 53002-7341-1?

    The NDC Packaged Code 53002-7341-1 is assigned to a package of 1 tube, with applicator in 1 carton / 70 g in 1 tube, with applicator of Vandazole, a human prescription drug labeled by Rpk Pharmaceuticals, Inc.. The product's dosage form is gel and is administered via vaginal form.

    Is NDC 53002-7341 included in the NDC Directory?

    Yes, Vandazole with product code 53002-7341 is active and included in the NDC Directory. The product was first marketed by Rpk Pharmaceuticals, Inc. on October 04, 2005 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 53002-7341-1?

    The 11-digit format is 53002734101. 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
    5-4-153002-7341-15-4-253002-7341-01