NDC Package 64725-0691-1 Sunmark Nicotine

View Billable Units, 11-Digit Format, RxNorm

Package Information

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

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
64725-0691-1
Package Description:
100 GUM, CHEWING in 1 BOX
Product Code:
Proprietary Name:
Sunmark Nicotine
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. •
11-Digit NDC Billing Format:
64725069101
NDC to RxNorm Crosswalk:
Labeler Name:
Tya Pharmaceuticals
Sample Package:
No
FDA Application Number:
ANDA078325
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
06-23-2005
Listing Expiration Date:
12-31-2017
Exclude Flag:
I
Code Structure:

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 disclaimer below.

Frequently Asked Questions

What is NDC 64725-0691-1?

The NDC Packaged Code 64725-0691-1 is assigned to a package of 100 gum, chewing in 1 box of Sunmark Nicotine, labeled by Tya Pharmaceuticals. The product's dosage form is and is administered via form.

Is NDC 64725-0691 included in the NDC Directory?

No, Sunmark Nicotine with product code 64725-0691 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Tya Pharmaceuticals on June 23, 2005 and its listing in the NDC Directory is set to expire on December 31, 2017 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 64725-0691-1?

The 11-digit format is 64725069101. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-4-164725-0691-15-4-264725-0691-01