Nicotine
NDC 54868-5819

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 54868-5819?
  4. Nicotine Transdermal System Step 3 Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

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

Nicotine is a NDA-approved product labeled by Physicians Total Care, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 54868-5819 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
54868-5819
Proprietary Name:
Nicotine Transdermal System Step 3
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Physicians Total Care, Inc.
Labeler Code:
54868
Product Label ID:
97384a5e-6803-4fe0-8d53-5932c5d698ad
FDA Application Number: [6]
NDA020076
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
09-19-2007
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I

Code Structure Chart

Product Details

What is NDC 54868-5819?

The NDC code 54868-5819 is assigned by the FDA to the product Nicotine Transdermal System Step 3. This pharmaceutical product is labeled by Physicians Total Care, Inc. and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 54868-5819-0. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

If you are under 18 years of age, ask a doctor before usebefore using this product, read the enclosed self-help guide for complete directions and other informationstop smoking completely when you begin using the patchif you smoke more than 10 cigarettes per day, use the following schedule below: if you smoke 10 or less cigarettes per day, start with Step 2 for 6 weeks, then Step 3 for 2 weeks and then stopapply one new patch every 24 hours on skin that is dry, clean and hairless remove backing from patch and immediately press onto skin. Hold for 10 seconds.wash hands after applying or removing patch. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch. the used patch should be removed and a new one applied to a different skin site at the same time each dayif you have vivid dreams, you may remove the patch at bedtime and apply a new one in the morningdo not wear more than one patch at a timedo not cut patch in half or into smaller piecesdo not leave patch on for more than 24 hours because it may irritate your skin and loses strength after 24 hoursto avoid possible burns, remove patch  before  undergoing any MRI (magnetic resonance imaging) proceduresstop using the patch at the end of 8 weeks. If you still feel the need to use the patch talk to your doctor.

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 this product?

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:

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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".