Nicotine Polacrilex Gum, Chewing
NDC Package 68016-293-44

11-digit billing NDC: 68016029344
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Nicotine Polacrilex gums 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 informationbegin using the gum on your quit dayif you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine gumif you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine gum according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 piece every 1 to 2 hours1 piece every 2 to 4 hours1 piece every 4 to 8 hoursnicotine gum is a medicine and must be used a certain way to get the best resultschew the gum slowly until it tingles. This formulation utilizes a gum, chewing delivery system. Marketed by Chain Drug Consortium, Llc, this product is identified by NDC 68016-293 and is authorized under FDA application ANDA204833.

Identification & Billing

NDC Package Code
68016-293-44
Package Description
100 BLISTER PACK in 1 CARTON / 1 GUM, CHEWING in 1 BLISTER PACK
Product Code
68016-293
11-Digit Billing Format
68016029344
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nicotine Polacrilex
Non-Proprietary Name
Nicotine Polacrilex
Substance Name
Nicotine
Dosage Form
Gum, Chewing - A sweetened and flavored insoluble plastic material of various shapes which when chewed, releases a drug substance into the oral cavity.
Administration Route
Buccal - Administration directed toward the cheek, generally from within the mouth.
Active Ingredient(s)
NICOTINE 4 mg/1
Pharmacologic Class
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 informationbegin using the gum on your quit dayif you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine gumif you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine gum according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 piece every 1 to 2 hours1 piece every 2 to 4 hours1 piece every 4 to 8 hoursnicotine gum is a medicine and must be used a certain way to get the best resultschew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again until the tingle returns.repeat this process until most of the tingle is gone (about 30 minutes)do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a pieceto improve your chances of quitting, use at least 9 pieces per day for the first 6 weeksif you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects.do not use more than 24 pieces a dayit is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider.

Regulatory & Marketing

Labeler Name
Chain Drug Consortium, Llc
Product Type
Human Otc Drug
FDA Application #
ANDA204833
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-01-2017
End Marketing Date
02-28-2027
Exclude Flag
N
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 68016-293-44 identifies a specific commercial package of 100 blister pack in 1 carton / 1 gum, chewing in 1 blister pack of Nicotine Polacrilex, a human over the counter drug labeled by Chain Drug Consortium, Llc. This gum, chewing is formulated for buccal use and contains nicotine as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Chain Drug Consortium, Llc on October 01, 2017.

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: 68016029344. 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)
68016-293-44
11-Digit CMS (5-4-2)
68016-0293-44

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