Nicotine Transdermal System Film, Extended Release
NDC Package 76282-783-40

11-digit billing NDC: 76282078340 · Billing unit: EA · 14 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Nicotine Transdermal System (nicotine) films is if you are under 18 years of age, ask a doctor before usebefore 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 6 Weeks 7 and 8 Step 1Step 2Step 3 use one 21 mg patch/day use one 14 mg patch/day use 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 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 film, extended release delivery system. Marketed by Exelan Pharmaceuticals, Inc., this product is identified by NDC 76282-783 and is authorized under FDA application ANDA074612.

Identification & Billing

NDC Package Code
76282-783-40
Package Description
14 POUCH in 1 CARTON / 1 h in 1 POUCH
Product Code
76282-783
11-Digit Billing Format
76282078340
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
Film, Extended Release - A drug delivery system in the form of a film that releases the drug over an extended period in such a way as to maintain constant drug levels in the blood or target tissue.
Administration Route
Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
Active Ingredient(s)
NICOTINE 21 mg/24h
Pharmacologic Class
Usage Information
If you are under 18 years of age, ask a doctor before usebefore 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 6 Weeks 7 and 8 Step 1Step 2Step 3 use one 21 mg patch/day use one 14 mg patch/day use 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 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 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
Exelan Pharmaceuticals, Inc.
Product Type
Human Otc Drug
FDA Application #
ANDA074612
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-13-2025
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 76282-783-40 identifies a specific commercial package of 14 pouch in 1 carton / 1 h in 1 pouch of Nicotine Transdermal System, a human over the counter drug labeled by Exelan Pharmaceuticals, Inc.. This film, 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 Exelan Pharmaceuticals, Inc. on October 13, 2025. The current certification is valid through December 31, 2026.

How is this Exelan Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76282078340. 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)
76282-783-40
11-Digit CMS (5-4-2)
76282-0783-40

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