Rugby Nicotine Polacrilex Gum, Coated Mint Flavor Gum, Chewing
NDC Package 0536-3113-01

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

Rugby Nicotine Polacrilex Gum, Coated Mint Flavor (nicotine polacrilex) gums is this medication can help you quit smoking by replacing the nicotine in cigarettes. This formulation utilizes a gum, chewing delivery system. Marketed by Rugby Laboratories, this product is identified by NDC 0536-3113 and is authorized under FDA application ANDA078697.

Identification & Billing

NDC Package Code
0536-3113-01
Package Description
10 BLISTER PACK in 1 CARTON / 10 GUM, CHEWING in 1 BLISTER PACK
Product Code
0536-3113
11-Digit Billing Format
00536311301
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
10 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Rugby Nicotine Polacrilex Gum, Coated Mint Flavor
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
This medication can help you quit smoking by replacing the nicotine in cigarettes. The nicotine in tobacco is an important part of cigarette addiction. When you stop smoking, your nicotine levels drop quickly. This drop can cause withdrawal symptoms such as craving tobacco, nervousness, irritability, headache, weight gain, and difficulty concentrating. Stopping smoking is hard and your chance of success is best when you are ready and have made a commitment to quit. Nicotine replacement products are part of a total stop-smoking program that includes behavior change, counseling, and support. Smoking causes lung disease, cancer, and heart disease. Stopping smoking is one of the most important things you can do to improve your health and live longer.

Regulatory & Marketing

Labeler Name
Rugby Laboratories
Product Type
Human Otc Drug
FDA Application #
ANDA078697
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-29-2008
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0536-3113). Click a package code to view its specific billing and regulatory data.

0536-3113-37
4 BLISTER PACK in 1 CARTON / 10 GUM, CHEWING in 1 BLISTER PACK
0536-3113-37
4 BLISTER PACK in 1 CARTON / 10 GUM 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 0536-3113-01 identifies a specific commercial package of 10 blister pack in 1 carton / 10 gum, chewing in 1 blister pack of Rugby Nicotine Polacrilex Gum, Coated Mint Flavor, a human over the counter drug labeled by Rugby Laboratories. 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 Rugby Laboratories on December 29, 2008. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication can help you quit smoking by replacing the nicotine in cigarettes. The nicotine in tobacco is an important part of cigarette addiction. When you stop smoking, your nicotine levels drop quickly. This drop can cause withdrawal symptoms such as craving tobacco, nervousness, irritability, headache, weight gain, and difficulty concentrating. Stopping smoking is hard and your chance of success is best when you are ready and have made a commitment to quit. Nicotine replacement products are part of a total stop-smoking program that includes behavior change, counseling, and support. Smoking causes lung disease, cancer, and heart disease. Stopping smoking is one of the most important things you can do to improve your health and live longer.

How is this Rugby Laboratories product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00536311301. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 10 total billable units per package. 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 (4-4-2)
0536-3113-01
11-Digit CMS (5-4-2)
00536-3113-01

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