Nicotine Lozenge
NDC Package 0363-4098-27

11-digit billing NDC: 00363409827
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Nicotine (nicotine polacrilex) lozenges is •if you are under 18 years of age, ask a doctor before use. This formulation utilizes a lozenge delivery system. Marketed by Walgreen Company, this product is identified by NDC 0363-4098 and is authorized under FDA application ANDA077007.

Identification & Billing

NDC Package Code
0363-4098-27
Package Description
2 CONTAINER in 1 CARTON / 40 LOZENGE in 1 CONTAINER (0363-4098-40)
Product Code
0363-4098
11-Digit Billing Format
00363409827

Clinical Specifications

Proprietary Name
Nicotine
Non-Proprietary Name
Nicotine Polacrilex
Substance Name
Nicotine
Dosage Form
Lozenge - A solid preparation containing one or more medicaments, usually in a flavored, sweetened base which is intended to dissolve or disintegrate slowly in the mouth. A lollipop is a lozenge on a stick.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
NICOTINE 4 mg/1
Pharmacologic Class
Usage Information
•if you are under 18 years of age, ask a doctor before use. No studies have been done to show if this product will work for you.•before using this product, read the enclosed User’s Guide for complete directions and other important information•begin using the lozenge on your quit day•if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge•if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge according to the following 12 week schedule:Weeks 1 to 6Weeks 7 to 9Weeks 10 to 121 lozenge every1 to 2 hours1 lozenge every2 to 4 hours1 lozenge every4 to 8 hours•nicotine lozenge is a medicine and must be used a certain way to get the best results •place the lozenge in your mouth and allow the lozenge to slowly dissolve. Minimize swallowing.Do not chew or swallow lozenge.•you may feel a warm or tingling sensation•occasionally move the lozenge from one side of your mouth to the other until completely dissolved •do not eat or drink 15 minutes before using or while the lozenge is in your mouth•to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks•do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects•do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day.•it is important to complete treatment. If you feel you need to use the lozenge for a longer period to keep from smoking, talk to your health care provider.

Regulatory & Marketing

Labeler Name
Walgreen Company
Product Type
Human Otc Drug
FDA Application #
ANDA077007
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-14-2026
Listing Expiration
12-31-2027
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 0363-4098-27 identifies a specific commercial package of 2 container in 1 carton / 40 lozenge in 1 container (0363-4098-40) of Nicotine, a human over the counter drug labeled by Walgreen Company. This lozenge is formulated for oral 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 Walgreen Company on August 14, 2026. The current certification is valid through December 31, 2027.

How is this Walgreen Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00363409827. 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 (4-4-2)
0363-4098-27
11-Digit CMS (5-4-2)
00363-4098-27

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