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  4. NDC Product Code: 49035-195 Nicotine Transdermal System

NDC 49035-195 Nicotine Transdermal System

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 49035-195?
  4. Nicotine Transdermal System Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing expired due to lack of listing certification.

Get all the details for National Drug Code (NDC) 49035-195 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
49035-195
Proprietary Name:
Nicotine Transdermal System
Product Type: [3]
Labeler Name: [5]
Wal-mart Stores Inc
Labeler Code:
49035
Product Label ID:
aefd30c4-35d5-425e-855c-327a7c436188
FDA Application Number: [6]
NDA020165
Marketing Category: [8]
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date: [9]
10-19-2010
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
U
Code Navigator:

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Product Details

What is NDC 49035-195?

The NDC code 49035-195 is assigned by the FDA to the product Nicotine Transdermal System which is product labeled by Wal-mart Stores Inc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 49035-195-02 14 patch in 1 carton / 24 h in 1 patch. 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 Transdermal System?

•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 information•stop smoking completely when you begin using the patch•if you smoke more than 10 cigarettes per day, use according to the following 10 week schedule: STEP 1STEP 2STEP 3Use one 21mg patch/dayUse one 14mg patch/dayUse one 7mg patch/dayWeeks 1-6Weeks 7-8Weeks 9-10•if you smoke 10 or less cigarettes per day, do not use STEP 1 (21mg). Start with STEP 2 (14mg) for 6 weeks, then STEP 3 (7mg) for 2 weeks and then stop.•steps 2 and 3 allow you to gradually reduce your level of nicotine. Completing the full program will increase your chances of quitting successfully.•apply one new patch every 24 hours on skin that is dry, clean and hairless. Save pouch for disposing of the patch after use•remove backing from patch and immediately press onto skin. Hold for 10 seconds.•wash hands after applying or removing patch. Throw away the patch by folding sticky ends together. Replace in its pouch and discard. See enclosed User’s Guide for safety and handling. •you may wear the patch for 16 or 24 hours.•if you crave cigarettes when you wake up, wear the patch for 24 hours.•if you have vivid dreams or other sleep disturbances, you may remove the patch at bedtime and apply a new one in the morning•the used patch should be removed and a new one applied to a different skin site at the same time each day•do not wear more than one patch at a time•do not cut patch in half or into smaller pieces•do not leave patch on for more than 24 hours because it may irritate your skin and loses strength after 24 hours•stop using the patch at the end of 10 weeks. If you started with STEP 2, stop 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 Nicotine Transdermal System UNII Codes?

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

Which are Nicotine Transdermal System 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:

  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) (UNII: L5F16ZG4ZU)

What is the NDC to RxNorm Crosswalk for Nicotine Transdermal System?

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 Transdermal Patch


Nicotine skin patches are used to help people stop smoking cigarettes. They provide a source of nicotine that reduces the withdrawal symptoms experienced when smoking is stopped.
[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.

[6] 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.

[8] 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.

[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, 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".