Nicotine
NDC Package 58118-9842-4

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 •Stop smoking completely when you begin using the patch •If you smoke more than 10 cigarettes per day, use the following schedule: Weeks 1 thru 4 Weeks 5 and 6 Weeks 7 and 8 STEP 1 STEP 2 STEP 3 use one 21 mg patch/day use one 14 mg patch/day use 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 and then stop •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 Clinical Solutions Wholesale, this product is identified by NDC 58118-9842 and is authorized under FDA application ANDA074612.

Identification & Billing

NDC Package Code
58118-9842-4
Package Description
14 POUCH in 1 CARTON / 1 PATCH in 1 POUCH (58118-9842-1) / 24 h in 1 PATCH
Product Code
58118-9842
11-Digit Billing Format
58118984204
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nicotine
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 •Stop smoking completely when you begin using the patch •If you smoke more than 10 cigarettes per day, use the following schedule: Weeks 1 thru 4 Weeks 5 and 6 Weeks 7 and 8 STEP 1 STEP 2 STEP 3 use one 21 mg patch/day use one 14 mg patch/day use 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 and then stop •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 used patch 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 •Stop 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
Clinical Solutions Wholesale
FDA Application #
ANDA074612
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-20-1997
Listing Expiration
12-31-2019
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 58118-9842-4 identifies a specific commercial package of 14 pouch in 1 carton / 1 patch in 1 pouch (58118-9842-1) / 24 h in 1 patch of Nicotine, labeled by Clinical Solutions Wholesale. 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 Clinical Solutions Wholesale on October 20, 1997. The current certification is valid through December 31, 2019.

How is this Clinical Solutions Wholesale product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58118984204. 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)
58118-9842-4
11-Digit CMS (5-4-2)
58118-9842-04

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