Nicorette
NDC Package 0135-0509-03

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

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Nicorette is •if you are under 18 years of age, ask a doctor before use. Marketed by Haleon Us Holdings Llc, this product is identified by NDC 0135-0509 and is authorized under FDA application NDA022360.

Identification & Billing

NDC Package Code
0135-0509-03
Package Description
5 CONTAINER in 1 CARTON / 27 LOZENGE in 1 CONTAINER
Product Code
0135-0509
11-Digit Billing Format
00135050903
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
5 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nicorette
Dosage Form
-
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 within 30 minutes of waking up, use 4 mg nicotine lozenge•if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge according to the following 12 week schedule:Weeks 1 to 6Weeks 7 to 9Weeks 10 to 121 lozenge every 1 to 2 hours1 lozenge every 2 to 4 hours1 lozenge every 4 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
Haleon Us Holdings Llc
FDA Application #
NDA022360
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-01-2010
End Marketing Date
08-31-2024
Listing Expiration
08-31-2024
Exclude Flag
D
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 (0135-0509). Click a package code to view its specific billing and regulatory data.

0135-0509-02
3 CONTAINER in 1 CARTON / 27 LOZENGE in 1 CONTAINER
0135-0509-04
20 LOZENGE in 1 CONTAINER

* 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 0135-0509-03 identifies a specific commercial package of 5 container in 1 carton / 27 lozenge in 1 container of Nicorette, labeled by Haleon Us Holdings Llc. 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 Haleon Us Holdings Llc on March 01, 2010. The current certification is valid through August 31, 2024.

How is this Haleon Us Holdings Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00135050903. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 5 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 (4-4-2)
0135-0509-03
11-Digit CMS (5-4-2)
00135-0509-03

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