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  5. NDC Package Code: 70000-0350-1 Leader Nicotine

NDC Package 70000-0350-1 Leader Nicotine

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

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:
70000-0350-1
Package Description:
3 CONTAINER in 1 CARTON / 24 LOZENGE in 1 CONTAINER
Product Code:
70000-0350
Proprietary Name:
Leader Nicotine
Usage Information:
•if you are under 18 years of age, ask a doctor before use. No studies have been done to show if this product will work for you.•before using this product, read the enclosed User’s Guide for complete directions and other important information•begin using the lozenge on your quit day•if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge •if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge according to the following 12 week schedule:Weeks 1 to 6Weeks 7 to 9Weeks 10 to 121 lozenge every1 to 2 hours1 lozenge every2 to 4 hours1 lozenge every4 to 8 hours•nicotine lozenge is a medicine and must be used a certain way to get the best results•place the lozenge in your mouth and allow the lozenge to slowly dissolve (about 20-30 minutes). Minimize swallowing. Do not chew or swallow lozenge.•you may feel a warm or tingling sensation•occasionally move the lozenge from one side of your mouth to the other until completely dissolved (about 20-30 minutes)•do not eat or drink 15 minutes before using or while the lozenge is in your mouth•to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks•do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects•do not use more than 5 lozenges in 6 hours.Do not use more than 20 lozenges per day.•it is important to complete treatment. If you feel you need to use the lozenge for a longer period to keep from smoking, talk to your health care provider.
11-Digit NDC Billing Format:
70000035001
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
3 EA
Labeler Name:
Cardinal Health 110, Llc. Dba Leader
Sample Package:
No
FDA Application Number:
ANDA077007
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
04-17-2018
End Marketing Date:
02-28-2022
Listing Expiration Date:
02-28-2022
Exclude Flag:
D
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 70000-0350-1?

The NDC Packaged Code 70000-0350-1 is assigned to a package of 3 container in 1 carton / 24 lozenge in 1 container of Leader Nicotine, labeled by Cardinal Health 110, Llc. Dba Leader. The product's dosage form is and is administered via form.

Is NDC 70000-0350 included in the NDC Directory?

No, Leader Nicotine with product code 70000-0350 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Cardinal Health 110, Llc. Dba Leader on April 17, 2018 and its listing in the NDC Directory is set to expire on February 28, 2022 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 70000-0350-1?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 3.

What is the 11-digit format for NDC 70000-0350-1?

The 11-digit format is 70000035001. 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
5-4-170000-0350-15-4-270000-0350-01