Sunmark Nicotine
NDC Package 64725-0691-1

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.

Sunmark Nicotine is if you are under 18 years of age, ask a doctor before use •before using this product, read the enclosed User’s Guide for complete directions and other important information •stop smoking completely when you begin using the gum •if you smoke your first cigarette within 30 minutes of waking up, use Nicotine Polacrilex Gum, 4 mg •if you smoke your first cigarette more than 30 minutes after waking up, use Nicotine Polacrilex Gum, 2 mg according to the following 12 week schedule: •Weeks 1 to 6Weeks 7 to 9Weeks 10 to 121 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 results •chew the gum slowly until it tingles. Marketed by Tya Pharmaceuticals, this product is identified by NDC 64725-0691 and is authorized under FDA application ANDA078325.

Identification & Billing

NDC Package Code
64725-0691-1
Package Description
100 GUM, CHEWING in 1 BOX
Product Code
64725-0691
11-Digit Billing Format
64725069101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sunmark Nicotine
Dosage Form
-
Usage Information
If you are under 18 years of age, ask a doctor before use •before using this product, read the enclosed User’s Guide for complete directions and other important information •stop smoking completely when you begin using the gum •if you smoke your first cigarette within 30 minutes of waking up, use Nicotine Polacrilex Gum, 4 mg •if you smoke your first cigarette more than 30 minutes after waking up, use Nicotine Polacrilex Gum, 2 mg according to the following 12 week schedule: •Weeks 1 to 6Weeks 7 to 9Weeks 10 to 121 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 results •chew 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 piece •to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks •if 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 day •it is important to complete treatment. Stop using the nicotine gum at the end of 12 weeks. If you still feel the need to use nicotine gum, talk to your doctor. •

Regulatory & Marketing

Labeler Name
Tya Pharmaceuticals
FDA Application #
ANDA078325
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-23-2005
Listing Expiration
12-31-2017
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 64725-0691-1 identifies a specific commercial package of 100 gum, chewing in 1 box of Sunmark Nicotine, labeled by Tya Pharmaceuticals. 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 Tya Pharmaceuticals on June 23, 2005. The current certification is valid through December 31, 2017.

How is this Tya Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64725069101. 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)
64725-0691-1
11-Digit CMS (5-4-2)
64725-0691-01

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