NDC 64725-0691 Sunmark Nicotine

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
64725-0691
Proprietary Name:
Sunmark Nicotine
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Tya Pharmaceuticals
Labeler Code:
64725
Start Marketing Date: [9]
06-23-2005
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - OFF WHITE)
Shape:
RECTANGLE (C48347)
Size(s):
16 MM
Score:
1

Product Packages

NDC Code 64725-0691-1

Package Description: 100 GUM, CHEWING in 1 BOX

Product Details

What is NDC 64725-0691?

The NDC code 64725-0691 is assigned by the FDA to the product Sunmark Nicotine which is product labeled by Tya Pharmaceuticals. The product's dosage form is . The product is distributed in a single package with assigned NDC code 64725-0691-1 100 gum, chewing in 1 box . 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 Sunmark Nicotine?

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. •

Which are Sunmark Nicotine UNII Codes?

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

Which are Sunmark Nicotine 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 Sunmark Nicotine?

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.

Product Footnotes

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

[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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".