Nicotine Lozenge
NDC Package 57237-321-72

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

Nicotine (nicotine polacrilex) lozenges is this medication can help you quit smoking by replacing the nicotine in cigarettes. This formulation utilizes a lozenge delivery system. Marketed by Rising Pharma Holdings, Inc., this product is identified by NDC 57237-321 and is authorized under FDA application ANDA207868.

Identification & Billing

NDC Package Code
57237-321-72
Package Description
3 BOTTLE, PLASTIC in 1 BOX / 24 LOZENGE in 1 BOTTLE, PLASTIC
Product Code
57237-321
11-Digit Billing Format
57237032172
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
3 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nicotine Mini
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
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
Rising Pharma Holdings, Inc.
Product Type
Human Otc Drug
FDA Application #
ANDA207868
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-10-2023
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 (57237-321). Click a package code to view its specific billing and regulatory data.

57237-321-42
1 BOTTLE, PLASTIC in 1 BOX / 24 LOZENGE in 1 BOTTLE, PLASTIC
57237-321-81
3 BOTTLE, PLASTIC in 1 BOX / 27 LOZENGE in 1 BOTTLE, PLASTIC (57237-321-27)

* 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 57237-321-72 identifies a specific commercial package of 3 bottle, plastic in 1 box / 24 lozenge in 1 bottle, plastic of Nicotine Mini, a human over the counter drug labeled by Rising Pharma Holdings, Inc.. 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 Rising Pharma Holdings, Inc. on August 10, 2023. 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 Rising Pharma Holdings, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57237032172. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 3 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 (5-3-2)
57237-321-72
11-Digit CMS (5-4-2)
57237-0321-72

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