Nicotine Transdermal System
NDC Package 11822-1603-1

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

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

Nicotine Transdermal System is 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. Marketed by Rite Aid Corporation, this product is identified by NDC 11822-1603 and is authorized under FDA application ANDA074612.

Identification & Billing

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
11-Digit Billing Format
11822160301
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nicotine Transdermal System
Dosage Form
-
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.

Regulatory & Marketing

Labeler Name
Rite Aid Corporation
FDA Application #
ANDA074612
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-15-2021
Listing Expiration
12-31-2025
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 11822-1603-1 identifies a specific commercial 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, labeled by Rite Aid Corporation. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Rite Aid Corporation on September 15, 2021. The current certification is valid through December 31, 2025.

How is this Rite Aid Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11822160301. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
11822-1603-1
11-Digit CMS (5-4-2)
11822-1603-01

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.