Nicotine Polacrilex
NDC Package 11822-3314-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

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

Nicotine Polacrilex 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 more than 30 minutes after waking up, use 2 mg nicotine gumif you smoke your first cigarette within 30 minutes of waking up, use 4 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. Marketed by Rite Aid Corporation, this product is identified by NDC 11822-3314 and is authorized under FDA application ANDA204833.

Identification & Billing

NDC Package Code
11822-3314-2
Package Description
160 BLISTER PACK in 1 CARTON / 1 GUM, CHEWING in 1 BLISTER PACK
Product Code
11822-3314
11-Digit Billing Format
11822331402

Clinical Specifications

Proprietary Name
Nicotine Polacrilex
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 informationbegin using the gum on your quit dayif you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine gumif you smoke your first cigarette within 30 minutes of waking up, use 4 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
Rite Aid Corporation
FDA Application #
ANDA204833
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-27-2019
End Marketing Date
04-30-2026
Listing Expiration
04-30-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (11822-3314). Click a package code to view its specific billing and regulatory data.

11822-3314-0
100 BLISTER PACK in 1 CARTON / 1 GUM, CHEWING in 1 BLISTER PACK
11822-3314-8
20 BLISTER PACK in 1 CARTON / 1 GUM, CHEWING in 1 BLISTER PACK

* 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 11822-3314-2 identifies a specific commercial package of 160 blister pack in 1 carton / 1 gum, chewing in 1 blister pack of Nicotine Polacrilex, labeled by Rite Aid Corporation. 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 Rite Aid Corporation on December 27, 2019. The current certification is valid through April 30, 2026.

How is this Rite Aid Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11822331402. 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)
11822-3314-2
11-Digit CMS (5-4-2)
11822-3314-02

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