NDC 11822-1603 Nicotine Transdermal System

Kit Transdermal - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
11822-1603
Proprietary Name:
Nicotine Transdermal System
Non-Proprietary Name: [1]
Nicotine Transdermal System
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Administration Route(s): [4]
  • Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
  • Labeler Name: [5]
    Rite Aid Corporation
    Labeler Code:
    11822
    FDA Application Number: [6]
    ANDA074612
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    09-15-2021
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 11822-1603-1

    Package Description: 1 KIT in 1 CARTON * 1 PATCH, EXTENDED RELEASE in 1 POUCH (11822-1601-0) * 1 PATCH, EXTENDED RELEASE in 1 POUCH (11822-1600-0) * 1 PATCH, EXTENDED RELEASE in 1 POUCH (11822-1602-0)

    Product Details

    What is NDC 11822-1603?

    The NDC code 11822-1603 is assigned by the FDA to the product Nicotine Transdermal System which is a human over the counter drug product labeled by Rite Aid Corporation. The product's dosage form is kit and is administered via transdermal form. The product is distributed in a single package with assigned NDC code 11822-1603-1 1 kit in 1 carton * 1 patch, extended release in 1 pouch (11822-1601-0) * 1 patch, extended release in 1 pouch (11822-1600-0) * 1 patch, extended release in 1 pouch (11822-1602-0). 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 self-help guide for complete directions and other informationbegin using the patch on your quit dayif you smoke more than 10 cigarettes per day, use the following schedule below: Weeks 1 thru 4Weeks 5 and 6Weeks 7 and 8Step 1Step 2Step 3Use one 21 mg patch/dayUse one 14 mg patch/dayUse one 7 mg patch/dayif you smoke 10 or less cigarettes per day, start with Step 2 for 6 weeks, then Step 3 for 2 weeksapply one new patch every 24 hours on skin that is dry, clean and hairlessremove 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 hoursit 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 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:

    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

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [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 ("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".