Habitrol Patch, Extended Release
NDC Package 55741-446-70

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Habitrol (nicotine transdermal system patch) patches is this medication can help you quit smoking by replacing the nicotine in cigarettes. This formulation utilizes a patch, extended release delivery system. Marketed by Dr. Reddy's Laboratories Inc., this product is identified by NDC 55741-446 and is authorized under FDA application NDA020076.

Identification & Billing

NDC Package Code
55741-446-70
Package Description
7 PATCH in 1 CARTON / 24 h in 1 PATCH
Product Code
55741-446
11-Digit Billing Format
55741044670
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Habitrol Step 3
Non-Proprietary Name
Nicotine Transdermal System Patch
Substance Name
Nicotine
Dosage Form
Patch, Extended Release - A drug delivery system in the form of a patch that releases the drug in such a manner that a reduction in dosing frequency compared to that drug presented as a conventional dosage form (e.g., a solution or a prompt drug-releasing, conventional solid dosage form).
Administration Route
Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
Active Ingredient(s)
NICOTINE 7 mg/24h
Pharmacologic Class
Usage Information
This medication can help you quit smoking by replacing the nicotine in cigarettes. The nicotine in tobacco is an important part of cigarette addiction. When you stop smoking, your nicotine levels drop quickly. This drop can cause withdrawal symptoms such as craving tobacco, nervousness, irritability, headache, weight gain, and difficulty concentrating. Stopping smoking is hard and your chance of success is best when you are ready and have made a commitment to quit. Nicotine replacement products are part of a total stop-smoking program that includes behavior change, counseling, and support. Smoking causes lung disease, cancer, and heart disease. Stopping smoking is one of the most important things you can do to improve your health and live longer.

Regulatory & Marketing

Labeler Name
Dr. Reddy's Laboratories Inc.
Product Type
Human Otc Drug
FDA Application #
NDA020076
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-13-2018
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (55741-446). Click a package code to view its specific billing and regulatory data.

55741-446-74
14 PATCH in 1 CARTON / 24 h in 1 PATCH

* 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 55741-446-70 identifies a specific commercial package of 7 patch in 1 carton / 24 h in 1 patch of Habitrol Step 3, a human over the counter drug labeled by Dr. Reddy's Laboratories Inc.. This patch, 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 Dr. Reddy's Laboratories Inc. on July 13, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication can help you quit smoking by replacing the nicotine in cigarettes. The nicotine in tobacco is an important part of cigarette addiction. When you stop smoking, your nicotine levels drop quickly. This drop can cause withdrawal symptoms such as craving tobacco, nervousness, irritability, headache, weight gain, and difficulty concentrating. Stopping smoking is hard and your chance of success is best when you are ready and have made a commitment to quit. Nicotine replacement products are part of a total stop-smoking program that includes behavior change, counseling, and support. Smoking causes lung disease, cancer, and heart disease. Stopping smoking is one of the most important things you can do to improve your health and live longer.

How is this Dr. Reddy's Laboratories Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55741044670. 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)
55741-446-70
11-Digit CMS (5-4-2)
55741-0446-70

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