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  5. NDC Package Code: 11822-1603-1 Nicotine Transdermal System

NDC Package 11822-1603-1 Nicotine Transdermal System

Kit Transdermal - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package 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 Code:
11822-1603
Proprietary Name:
Nicotine Transdermal System
Non-Proprietary Name:
Nicotine Transdermal System
Usage Information:
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.
11-Digit NDC Billing Format:
11822160301
NDC to RxNorm Crosswalk:
  • RxCUI: 198029 - nicotine 14 MG/Day 24HR Transdermal System
  • RxCUI: 198029 - 24 HR nicotine 0.583 MG/HR Transdermal System
  • RxCUI: 198029 - nicotine 0.583 MG/HR 24HR Transdermal Patch
  • RxCUI: 198029 - nicotine 14 MG per 24HR 1 Day Transdermal Patch
  • RxCUI: 198030 - nicotine 21 MG/Day 24HR Transdermal System
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Rite Aid Corporation
    Dosage Form:
    Kit - A packaged collection of related material.
    Administration Route(s):
  • Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
    • Sample Package:
    No
    FDA Application Number:
    ANDA074612
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-15-2021
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 11822-1603-1?

    The NDC Packaged Code 11822-1603-1 is assigned to a package of 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) of Nicotine Transdermal System, a human over the counter drug labeled by Rite Aid Corporation. The product's dosage form is kit and is administered via transdermal form.

    Is NDC 11822-1603 included in the NDC Directory?

    Yes, Nicotine Transdermal System with product code 11822-1603 is active and included in the NDC Directory. The product was first marketed by Rite Aid Corporation on September 15, 2021 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 11822-1603-1?

    The 11-digit format is 11822160301. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-4-111822-1603-15-4-211822-1603-01