NDC 68151-5980 Nicorette

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:
68151-5980
Proprietary Name:
Nicorette
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Code:
68151
Start Marketing Date: [9]
03-01-2010
Listing Expiration Date: [11]
12-31-2019
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - WHITE TO OFF-WHITE)
Shape:
OVAL (C48345)
Size(s):
10 MM
Imprint(s):
M
Score:
1
Flavor(s):
MINT (C73404)

Code Structure Chart

Product Details

What is NDC 68151-5980?

The NDC code 68151-5980 is assigned by the FDA to the product Nicorette which is product labeled by Carilion Materials Management. The product's dosage form is . The product is distributed in a single package with assigned NDC code 68151-5980-1 1 lozenge 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 Nicorette?

•if you are under 18 years of age, ask a doctor before use. No studies have been done to show if this product will work for you.•before using this product, read the enclosed User’s Guide for complete directions and other important information•begin using the lozenge on your quit day•if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge•if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge according to the following 12 week schedule:Weeks 1to 6Weeks 7 to 9Weeks 10 to 121 lozenge every 1 to 2 hours1 lozenge every 2 to 4 hours1 lozenge every 4 to 8 hours•nicotine lozenge is a medicine and must be used a certain way to get the best results•place the lozenge in your mouth and allow the lozenge to slowly dissolve. Minimize swallowing. Do not chew or swallow lozenge.•you may feel a warm or tingling sensation•occasionally move the lozenge from one side of your mouth to the other until completely dissolved•do not eat or drink 15 minutes before using or while the lozenge is in your mouth•to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks•do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects•do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day.•it is important to complete treatment. If you feel you need to use the lozenge for a longer period to keep from smoking, talk to your health care provider.

Which are Nicorette UNII Codes?

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

Which are Nicorette 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 Nicorette?

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".