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  5. NDC Package Code: 0168-0347-20 Terconazole Vaginal Cream 0.8%

NDC Package 0168-0347-20 Terconazole Vaginal Cream 0.8%

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:
0168-0347-20
Package Description:
20 g in 1 TUBE, WITH APPLICATOR
Product Code:
0168-0347
Proprietary Name:
Terconazole Vaginal Cream 0.8%
Non-Proprietary Name:
Terconazole
Substance Name:
Terconazole
Usage Information:
This medication is used to treat vaginal yeast infections. Terconazole 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.
11-Digit NDC Billing Format:
00168034720
Billing Unit:
GM - Billing unit of "gram" is used when a product is measured by its weight.
NDC to RxNorm Crosswalk:
20 GM
NDC to RxNorm Crosswalk:
  • RxCUI: 313227 - terconazole 0.8 % Vaginal Cream
  • RxCUI: 313227 - terconazole 8 MG/ML Vaginal Cream
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.
    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):
  • TERCONAZOLE 8 mg/g
    • Pharmacologic Class(es):
  • Azole Antifungal - [EPC] (Established Pharmacologic Class)
  • Azoles - [CS]
    • Sample Package:
    No
    FDA Application Number:
    NDA021735
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    02-01-2005
    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 0168-0347-20?

    The NDC Packaged Code 0168-0347-20 is assigned to a package of 20 g in 1 tube, with applicator of Terconazole Vaginal Cream 0.8%, a human prescription drug labeled by E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.. The product's dosage form is cream and is administered via vaginal form.

    Is NDC 0168-0347 included in the NDC Directory?

    Yes, Terconazole Vaginal Cream 0.8% with product code 0168-0347 is active and included in the NDC Directory. The product was first marketed by E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc. on February 01, 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 NDC billing unit for package 0168-0347-20?

    The contents of this package are billed per "gm or gram", products billed per gram are products measured by weight. The calculated billable units for this package is 20.

    What is the 11-digit format for NDC 0168-0347-20?

    The 11-digit format is 00168034720. 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
    4-4-20168-0347-205-4-200168-0347-20