Nicotine
NDC Package 54868-5821-0

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 usebefore using this product, read the enclosed self-help guide for complete directions and other informationstop smoking completely when you begin using the patchif you smoke more than 10 cigarettes per day, use the following schedule below: if you smoke 10 or less cigarettes per day, start with Step 2 for 6 weeks, then Step 3 for 2 weeks and then stopapply 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 Physicians Total Care, Inc., this product is identified by NDC 54868-5821 and is authorized under FDA application NDA020076.

Identification & Billing

NDC Package Code
54868-5821-0
Package Description
7 POUCH in 1 CARTON / 1 PATCH in 1 POUCH / 24 h in 1 PATCH
Product Code
54868-5821
11-Digit Billing Format
54868582100
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
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 usebefore using this product, read the enclosed self-help guide for complete directions and other informationstop smoking completely when you begin using the patchif you smoke more than 10 cigarettes per day, use the following schedule below: if you smoke 10 or less cigarettes per day, start with Step 2 for 6 weeks, then Step 3 for 2 weeks and then stopapply 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 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 hoursto avoid possible burns, remove patch  before  undergoing any MRI (magnetic resonance imaging) proceduresstop using the patch at the end of 8 weeks. If you still feel the need to use the patch talk to your doctor.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA020076
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-19-2007
Listing Expiration
12-31-2017
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 54868-5821-0 identifies a specific commercial package of 7 pouch in 1 carton / 1 patch in 1 pouch / 24 h in 1 patch of Nicotine Transdermal System Step 1, labeled by Physicians Total Care, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. 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 Physicians Total Care, Inc. on September 19, 2007. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868582100. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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 (5-4-1)
54868-5821-0
11-Digit CMS (5-4-2)
54868-5821-00

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