Nicotine Transdermal System Patch, Extended Release
NDC Package 46122-831-45

11-digit billing NDC: 46122083145
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Nicotine Transdermal System (nicotine) patches 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 information•begin using the patch on your quit day•if 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/day•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. This formulation utilizes a patch, extended release delivery system. Marketed by Amerisourcebergen Drug Corporation, this product is identified by NDC 46122-831 and is authorized under FDA application NDA020076.

Identification & Billing

NDC Package Code
46122-831-45
Package Description
14 PATCH in 1 CARTON / 24 h in 1 PATCH
Product Code
46122-831
11-Digit Billing Format
46122083145
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nicotine Transdermal System Step 3
Non-Proprietary Name
Nicotine
Substance Name
Nicotine
Dosage Form
Patch, Extended Release - A drug delivery system in the form of a patch that releases the drug in such a manner that a reduction in dosing frequency compared to that drug presented as a conventional dosage form (e.g., a solution or a prompt drug-releasing, conventional solid dosage form).
Administration Route
Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
Active Ingredient(s)
NICOTINE 7 mg/24h
Pharmacologic Class
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 information•begin using the patch on your quit day•if 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/day•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.

Regulatory & Marketing

Labeler Name
Amerisourcebergen Drug Corporation
Product Type
Human Otc Drug
FDA Application #
NDA020076
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-01-2026
Listing Expiration
12-31-2027
Exclude Flag
N
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 46122-831-45 identifies a specific commercial package of 14 patch in 1 carton / 24 h in 1 patch of Nicotine Transdermal System Step 3, a human over the counter drug labeled by Amerisourcebergen Drug Corporation. This patch, extended release is formulated for transdermal use and contains nicotine as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Amerisourcebergen Drug Corporation on July 01, 2026. The current certification is valid through December 31, 2027.

How is this Amerisourcebergen Drug Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46122083145. 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 (5-3-2)
46122-831-45
11-Digit CMS (5-4-2)
46122-0831-45

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