NDC 68196-011 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:
68196-011
Proprietary Name:
Nicotine
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Sam's West, Inc.
Labeler Code:
68196
Start Marketing Date: [9]
10-16-2017
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - OFF-WHITE TO TAN)
YELLOW (C48330)
Shape:
SQUARE (C48350)
Size(s):
14 MM
Score:
1

Product Packages

NDC Code 68196-011-02

Package Description: 396 BLISTER PACK in 1 CARTON / 33 GUM, CHEWING in 1 BLISTER PACK

Product Details

What is NDC 68196-011?

The NDC code 68196-011 is assigned by the FDA to the product Nicotine which is product labeled by Sam's West, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 68196-011-02 396 blister pack in 1 carton / 33 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?

If you are under 18 years of age, ask a doctor before usebefore using this product, read the enclosed User's Guide for complete instructions and other important informationbegin using the gum on your quit dayif 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 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 in 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 UNII Codes?

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

Which are 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 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.

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.

[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".