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  4. NDC Product Code: 72484-428 Nicotine Polacrilex Coated Mint

NDC 72484-428 Nicotine Polacrilex Coated Mint

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 72484-428?
  5. Nicotine Polacrilex Coated Mint Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Get all the details for National Drug Code (NDC) 72484-428 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
72484-428
Proprietary Name:
Nicotine Polacrilex Coated Mint
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Roman Health Ventures Inc.
Labeler Code:
72484
Product Label ID:
d60f90a5-10ea-442b-9ec5-2f2a69ec6441
FDA Application Number: [6]
ANDA078699
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
10-08-2018
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
SQUARE (C48350)
Size(s):
14 MM
Score:
1
Flavor(s):
MINT (C73404)

Code Structure Chart

Product Details

What is NDC 72484-428?

The NDC code 72484-428 is assigned by the FDA to the product Nicotine Polacrilex Coated Mint which is product labeled by Roman Health Ventures Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 72484-428-16 160 blister pack in 1 carton / 1 gum, chewing in 1 blister pack. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Nicotine Polacrilex Coated Mint?

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.

Which are Nicotine Polacrilex Coated Mint UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Nicotine Polacrilex Coated Mint Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Nicotine Polacrilex Coated Mint?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

* Please review the disclaimer below.

Patient Education

Nicotine Gum


Nicotine chewing gum is used to help people stop smoking cigarettes. Nicotine chewing gum should be used together with a smoking cessation program, which may include support groups, counseling, or specific behavioral change techniques. Nicotine gum is in a class of medications called smoking cessation aids. It works by providing nicotine to your body to decrease the withdrawal symptoms experienced when smoking is stopped and as a substitute oral activity to reduce the urge to smoke.
[Learn More]


* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".