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  5. NDC Package Code: 0168-0383-60 Metronidazole

NDC Package 0168-0383-60 Metronidazole

Lotion 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:
0168-0383-60
Package Description:
59 mL in 1 BOTTLE, PLASTIC
Product Code:
0168-0383
Proprietary Name:
Metronidazole
Non-Proprietary Name:
Metronidazole
Substance Name:
Metronidazole
Usage Information:
Metronidazole is an antibiotic that is used to treat a wide variety of infections. It works by stopping the growth of certain bacteria and parasites. This antibiotic treats only certain bacterial and parasitic infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections. Metronidazole may also be used with other medications to treat certain stomach/intestinal ulcers caused by a bacteria (H. pylori).
11-Digit NDC Billing Format:
00168038360
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
59 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 242736 - metroNIDAZOLE 0.75 % Topical Lotion
  • RxCUI: 242736 - metronidazole 7.5 MG/ML Topical Lotion
  • RxCUI: 242736 - metronidazole 0.75 % Topical Lotion
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Fougera Pharmaceuticals Inc.
    Dosage Form:
    Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
    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):
  • METRONIDAZOLE 7.5 mg/mL
    • Pharmacologic Class(es):
  • Nitroimidazole Antimicrobial - [EPC] (Established Pharmacologic Class)
  • Nitroimidazoles - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA077197
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-24-2006
    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 0168-0383-60?

    The NDC Packaged Code 0168-0383-60 is assigned to a package of 59 ml in 1 bottle, plastic of Metronidazole, a human prescription drug labeled by Fougera Pharmaceuticals Inc.. The product's dosage form is lotion and is administered via topical form.

    Is NDC 0168-0383 included in the NDC Directory?

    Yes, Metronidazole with product code 0168-0383 is active and included in the NDC Directory. The product was first marketed by Fougera Pharmaceuticals Inc. on May 24, 2006 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 NDC billing unit for package 0168-0383-60?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 59.

    What is the 11-digit format for NDC 0168-0383-60?

    The 11-digit format is 00168038360. 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 4-4-2 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
    4-4-20168-0383-605-4-200168-0383-60