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  5. NDC Package Code: 70000-0338-1 Terbinafine Hydrochloride

NDC Package 70000-0338-1 Terbinafine Hydrochloride

Cream 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:
70000-0338-1
Package Description:
1 TUBE in 1 CARTON / 15 g in 1 TUBE
Product Code:
70000-0338
Proprietary Name:
Terbinafine Hydrochloride
Non-Proprietary Name:
Terbinafine Hydrochloride
Substance Name:
Terbinafine Hydrochloride
Usage Information:
Adults and children 12 years and over: use the tip of the cap to break the seal and open the tubewash the affected skin with soap and water and dry completely before applyingfor athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily. between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctoron the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctorfor jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctorwash hands after each usechildren under 12 years: ask a doctor1 weekbetween the toes2 weeks on the bottomor sides of the foot
11-Digit NDC Billing Format:
70000033801
Billing Unit:
GM - Billing unit of "gram" is used when a product is measured by its weight.
NDC to RxNorm Crosswalk:
15 GM
NDC to RxNorm Crosswalk:
  • RxCUI: 992528 - terbinafine HCl 1 % Topical Cream
  • RxCUI: 992528 - terbinafine hydrochloride 10 MG/ML Topical Cream
  • RxCUI: 992528 - terbinafine hydrochloride 1 % Topical Cream
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Cardinal Health, 110 Dba Leader
    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):
  • 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):
  • TERBINAFINE HYDROCHLORIDE 1 g/100g
    • Pharmacologic Class(es):
  • Allylamine Antifungal - [EPC] (Established Pharmacologic Class)
  • Allylamine - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA077511
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-30-2018
    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 70000-0338-1?

    The NDC Packaged Code 70000-0338-1 is assigned to a package of 1 tube in 1 carton / 15 g in 1 tube of Terbinafine Hydrochloride, a human over the counter drug labeled by Cardinal Health, 110 Dba Leader. The product's dosage form is cream and is administered via topical form.

    Is NDC 70000-0338 included in the NDC Directory?

    Yes, Terbinafine Hydrochloride with product code 70000-0338 is active and included in the NDC Directory. The product was first marketed by Cardinal Health, 110 Dba Leader on July 30, 2018 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 70000-0338-1?

    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 15.

    What is the 11-digit format for NDC 70000-0338-1?

    The 11-digit format is 70000033801. 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
    5-4-170000-0338-15-4-270000-0338-01