Mini Nicotine
NDC Package 68016-086-81

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
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.

Mini Nicotine is if you are under 18 years of age, ask a doctor before use. Marketed by Chain Drug Consortium, Llc, this product is identified by NDC 68016-086 and is authorized under FDA application ANDA207868.

Identification & Billing

NDC Package Code
68016-086-81
Package Description
3 BOTTLE, PLASTIC in 1 BOX / 27 LOZENGE in 1 BOTTLE, PLASTIC
Product Code
68016-086
11-Digit Billing Format
68016008681

Clinical Specifications

Proprietary Name
Mini Nicotine
Dosage Form
-
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 informationbegin using the lozenge on your quit dayif you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozengeif you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hoursnicotine lozenge is a medicine and must be used a certain way to get the best resultsplace the lozenge in your mouth and allow the lozenge to slowly dissolve. Minimize swallowing. Do not chew or swallow lozenge.you may feel a warm or tingling sensationoccasionally move the lozenge from one side of your mouth to the other until completely dissolveddo not eat or drink 15 minutes before using or while the lozenge is in your mouthto improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeksdo 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 effectsdo 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.

Regulatory & Marketing

Labeler Name
Chain Drug Consortium, Llc
FDA Application #
ANDA207868
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-30-2019
End Marketing Date
05-28-2026
Listing Expiration
05-28-2026
Exclude Flag
D
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68016-086-81 identifies a specific commercial package of 3 bottle, plastic in 1 box / 27 lozenge in 1 bottle, plastic of Mini Nicotine, labeled by Chain Drug Consortium, Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Chain Drug Consortium, Llc on April 30, 2019. The current certification is valid through May 28, 2026.

How is this Chain Drug Consortium, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68016008681. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
68016-086-81
11-Digit CMS (5-4-2)
68016-0086-81

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.