Nicotine Polacrilex
NDC Package 72484-428-16

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.

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 informationif 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 6Weeks 7 to 9  Weeks 10 to 12 1 piece every 1 to 2 hours1 piece every  2 to 4 hours 1 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 Roman Health Ventures Inc., this product is identified by NDC 72484-428 and is authorized under FDA application ANDA078699.

Identification & Billing

NDC Package Code
72484-428-16
Package Description
160 BLISTER PACK in 1 CARTON / 1 GUM, CHEWING in 1 BLISTER PACK
Product Code
72484-428
11-Digit Billing Format
72484042816
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nicotine Polacrilex Coated Mint
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 informationif 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 6Weeks 7 to 9  Weeks 10 to 12 1 piece every 1 to 2 hours1 piece every  2 to 4 hours 1 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
Roman Health Ventures Inc.
FDA Application #
ANDA078699
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-08-2018
Listing Expiration
12-31-2022
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 72484-428-16 identifies a specific commercial package of 160 blister pack in 1 carton / 1 gum, chewing in 1 blister pack of Nicotine Polacrilex Coated Mint, labeled by Roman Health Ventures 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 Roman Health Ventures Inc. on October 08, 2018. The current certification is valid through December 31, 2022.

How is this Roman Health Ventures Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72484042816. 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)
72484-428-16
11-Digit CMS (5-4-2)
72484-0428-16

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