Nicotine Patch, Extended Release
NDC Package 11673-196-02

11-digit billing NDC: 11673019602 · Billing unit: EA · 14 EA per package

Package Information

Nicotine patches is •if you are under 18 years of age, ask a doctor before use•before using this product, read the enclosed User’s 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 according to the following 10 week schedule: STEP 1STEP 2STEP 3Use one 21mg patch/dayUse one 14mg patch/dayUse one 7mg patch/dayWeeks 1-6Weeks 7-8Weeks 9-10•if you smoke 10 or less cigarettes per day, do not use STEP 1 (21mg). This formulation utilizes a patch, extended release delivery system. Marketed by Target Corporation, this product is identified by NDC 11673-196 and is authorized under FDA application NDA020165.

Identification & Billing

NDC Package Code
11673-196-02
Package Description
14 PATCH in 1 CARTON / 24 h in 1 PATCH
Product Code
11-Digit Billing Format
11673019602
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
14 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nicotine Transdermal System
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)
Usage Information
•if you are under 18 years of age, ask a doctor before use•before using this product, read the enclosed User’s 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 according to the following 10 week schedule: STEP 1STEP 2STEP 3Use one 21mg patch/dayUse one 14mg patch/dayUse one 7mg patch/dayWeeks 1-6Weeks 7-8Weeks 9-10•if you smoke 10 or less cigarettes per day, do not use STEP 1 (21mg). Start with STEP 2 (14mg) for 6 weeks, then STEP 3 (7mg) for 2 weeks and then stop.•steps 2 and 3 allow you to gradually reduce your level of nicotine. Completing the full program will increase your chances of quitting successfully.•apply one new patch every 24 hours on skin that is dry, clean and hairless. Save pouch for disposing of the patch after use.•remove backing from patch and immediately press onto skin. Hold for 10 seconds.•wash hands after applying or removing patch. Throw away the patch by folding sticky ends together. Replace in its pouch and discard. See enclosed User’s Guide for safety and handling. •you may wear the patch for 16 or 24 hours.•if you crave cigarettes when you wake up, wear the patch for 24 hours.•if you have vivid dreams or other sleep disturbances, you may remove the patch at bedtime and apply a new one in the morning•the used patch should be removed and a new one applied to a different skin site at the same time each day•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•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
Target Corporation
Product Type
Human Otc Drug
FDA Application #
NDA020165
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-16-2000
Listing Expiration
12-31-2026
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 11673-196-02 identifies a specific commercial package of 14 patch in 1 carton / 24 h in 1 patch of Nicotine Transdermal System, a human over the counter drug labeled by Target Corporation. This product is billed for "EA" each discreet unit and contains an estimated amount of 14 billable units per package. 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 Target Corporation on February 16, 2000. The current certification is valid through December 31, 2026.

How is this Target Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11673019602. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 14 total billable units per package. 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)
11673-196-02
11-Digit CMS (5-4-2)
11673-0196-02

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