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  4. NDC Product Code: 70000-0114 Nicotine Transdermal System Step 2

NDC 70000-0114 Nicotine Transdermal System Step 2

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 70000-0114?
  4. Nicotine Transdermal System Step 2 Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Get all the details for National Drug Code (NDC) 70000-0114 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:
70000-0114
Proprietary Name:
Nicotine Transdermal System Step 2
Product Type: [3]
Labeler Name: [5]
Cardinal Health
Labeler Code:
70000
Product Label ID:
c755c3e7-db91-4580-f783-1ab55576320f
FDA Application Number: [6]
NDA020076
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
03-31-2016
End Marketing Date: [10]
12-31-2017
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
D
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Product Details

What is NDC 70000-0114?

The NDC code 70000-0114 is assigned by the FDA to the product Nicotine Transdermal System Step 2 which is product labeled by Cardinal Health. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 70000-0114-1 7 patch in 1 carton / 24 h in 1 patch, 70000-0114-2 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 Step 2?

•if you are under 18 years of age, ask a doctor before use•before using this product, read the enclosed self-help guide for complete directions and other information•begin using the patch on your quit day•if you smoke more than 10 cigarettes per day, use the following schedule below: STEP 1STEP 2STEP 3Use one 21 mg patch/dayUse one 14 mg patch/dayUse one 7 mg patch/dayWeeks 1-4Weeks 5-6Weeks 7-8•if you smoke 10 or less cigarettes per day, start with Step 2 for 6 weeks, then Step 3 for 2 weeks •apply 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 day•if you have vivid dreams, you may remove the patch at bedtime and apply a new one in the morning•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•to avoid possible burns, remove patch before undergoing any MRI (magnetic resonance imaging) procedures•It is important to complete treatment. If you feel you need to use the patch for a longer period to keep from smoking, talk to your health care provider.

Which are Nicotine Transdermal System Step 2 UNII Codes?

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

Which are Nicotine Transdermal System Step 2 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:

* 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.

[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

[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".