Medline Patch
NDC Package 53329-191-89

11-digit billing NDC: 53329019189
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Medline (nicotine) patches 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: 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 hairlessremove backing from patch and immediately press onto skin. This formulation utilizes a patch delivery system. Marketed by Medline Industries, Lp, this product is identified by NDC 53329-191 and is authorized under FDA application ANDA074611.

Identification & Billing

NDC Package Code
53329-191-89
Package Description
14 POUCH in 1 CARTON / 1 PATCH in 1 POUCH (53329-191-09)
Product Code
53329-191
11-Digit Billing Format
53329019189
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Medline
Non-Proprietary Name
Nicotine
Substance Name
Nicotine
Dosage Form
Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.
Administration Route
Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
Active Ingredient(s)
NICOTINE 14 mg/1
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: 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 hairlessremove backing from patch and immediately press onto skin. Hold for 10 secondswash 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 hoursit 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
Medline Industries, Lp
Product Type
Human Otc Drug
FDA Application #
ANDA074611
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-30-2022
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 53329-191-89 identifies a specific commercial package of 14 pouch in 1 carton / 1 patch in 1 pouch (53329-191-09) of Medline, a human over the counter drug labeled by Medline Industries, Lp. This patch 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 Medline Industries, Lp on June 30, 2022. The current certification is valid through December 31, 2026.

How is this Medline Industries, Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53329019189. 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)
53329-191-89
11-Digit CMS (5-4-2)
53329-0191-89

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