Good Sense Nicotine
NDC Package 68258-7992-7

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 inactivated by the FDA.

Good Sense Nicotine is if you are under 18 years of age, ask a doctor before usebefore using this product, read the enclosed User’s Guide for complete directions and other important informationstop smoking completely when you begin using the lozengeif 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 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 (about 20-30 minutes). Marketed by Dispensing Solutions, Inc., this product is identified by NDC 68258-7992 and is authorized under FDA application ANDA077007.

Identification & Billing

NDC Package Code
68258-7992-7
Package Description
3 VIAL in 1 CARTON / 24 LOZENGE in 1 VIAL
Product Code
68258-7992
11-Digit Billing Format
68258799207
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Good Sense Nicotine
Dosage Form
-
Usage Information
If you are under 18 years of age, ask a doctor before usebefore using this product, read the enclosed User’s Guide for complete directions and other important informationstop smoking completely when you begin using the lozengeif 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 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 (about 20-30 minutes). 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 dissolved (about 20-30 minutes)do 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.stop using the nicotine lozenge at the end of 12 weeks. If you still feel the need to use nicotine lozenges, talk to your doctor.

Regulatory & Marketing

Labeler Name
Dispensing Solutions, Inc.
FDA Application #
ANDA077007
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-27-2006
Listing Expiration
12-31-2017
Exclude Flag
I
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 68258-7992-7 identifies a specific commercial package of 3 vial in 1 carton / 24 lozenge in 1 vial of Good Sense Nicotine, labeled by Dispensing Solutions, Inc.. 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 Dispensing Solutions, Inc. on December 27, 2006. The current certification is valid through December 31, 2017.

How is this Dispensing Solutions, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68258799207. 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 (5-4-1)
68258-7992-7
11-Digit CMS (5-4-2)
68258-7992-07

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