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  5. NDC Package Code: 70000-0400-1 Leader Calamine Plus

NDC Package 70000-0400-1 Leader Calamine Plus

Zinc Oxide Lotion 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:
70000-0400-1
Package Description:
177 mL in 1 CONTAINER
Product Code:
70000-0400
Proprietary Name:
Leader Calamine Plus
Non-Proprietary Name:
Zinc Oxide Lotion
Substance Name:
Pramoxine Hydrochloride; Zinc Oxide
Usage Information:
Uses: temporarily relieves pain and itching associated with: rashes due to poison ivy, poison oak, or poison sumacinsect bitesminor skin irritationminor cuts​dries the oozing and weeping of poison ivy, poison oak and poison sumac
11-Digit NDC Billing Format:
70000040001
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
177 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 1234532 - calamine 8 % / pramoxine HCl 1 % Topical Lotion
  • RxCUI: 1234532 - calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion
  • RxCUI: 1234532 - calamine 8 % / pramoxine hydrochloride 1 % Topical Lotion
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Cardinal Health, 110 Dba Leader
    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):
  • PRAMOXINE HYDROCHLORIDE 10 mg/mL
  • ZINC OXIDE 80 mg/mL
    • Pharmacologic Class(es):
  • Copper Absorption Inhibitor - [EPC] (Established Pharmacologic Class)
  • Decreased Copper Ion Absorption - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    M016
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    02-15-2019
    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 70000-0400-1?

    The NDC Packaged Code 70000-0400-1 is assigned to a package of 177 ml in 1 container of Leader Calamine Plus, a human over the counter drug labeled by Cardinal Health, 110 Dba Leader. The product's dosage form is lotion and is administered via topical form.

    Is NDC 70000-0400 included in the NDC Directory?

    Yes, Leader Calamine Plus with product code 70000-0400 is active and included in the NDC Directory. The product was first marketed by Cardinal Health, 110 Dba Leader on February 15, 2019 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 70000-0400-1?

    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 177.

    What is the 11-digit format for NDC 70000-0400-1?

    The 11-digit format is 70000040001. 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
    5-4-170000-0400-15-4-270000-0400-01