Nicotine
NDC Package 50090-1972-0

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 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: STEP 1STEP 2STEP 3Use one 21 mg patch/dayUse one 14 mg patch/dayUse one 7 mg patch/dayWeeks 1-4Weeks 5-6Weeks 7-8•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. Marketed by A-s Medication Solutions, this product is identified by NDC 50090-1972 and is authorized under FDA application NDA020076.

Identification & Billing

NDC Package Code
50090-1972-0
Package Description
14 PATCH in 1 CARTON / 24 h in 1 PATCH
Product Code
50090-1972
11-Digit Billing Format
50090197200
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nicotine Transdermal System Step 1
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 information•begin using the patch on your quit day•if you smoke more than 10 cigarettes per day, use the following schedule below: STEP 1STEP 2STEP 3Use one 21 mg patch/dayUse one 14 mg patch/dayUse one 7 mg patch/dayWeeks 1-4Weeks 5-6Weeks 7-8•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
A-s Medication Solutions
FDA Application #
NDA020076
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-14-2015
Listing Expiration
12-31-2022
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 50090-1972-0 identifies a specific commercial package of 14 patch in 1 carton / 24 h in 1 patch of Nicotine Transdermal System Step 1, labeled by A-s Medication Solutions. 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 A-s Medication Solutions on May 14, 2015. The current certification is valid through December 31, 2022.

How is this A-s Medication Solutions product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50090197200. 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)
50090-1972-0
11-Digit CMS (5-4-2)
50090-1972-00

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