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  5. NDC Package Code: 0135-1501-03 Nicotine Polacrilex

NDC Package 0135-1501-03 Nicotine Polacrilex

Lozenge - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0135-1501-03
Package Description:
3700000 LOZENGE in 1 DRUM
Product Code:
0135-1501
Non-Proprietary Name:
Nicotine Polacrilex
Substance Name:
Nicotine
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.
11-Digit NDC Billing Format:
00135150103
Product Type:
Drug For Further Processing
Labeler Name:
Glaxosmithkline Consumer Healthcare Holdings (us) Llc
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.
Active Ingredient(s):
  • NICOTINE 2 mg/1
    • Sample Package:
    N/A
    Marketing Category:
    DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
    Start Marketing Date:
    06-01-2022
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Unfinished Product:
    Yes
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 0135-1501-03?

    The NDC Packaged Code 0135-1501-03 is assigned to an UNFINISHED drug package of 3700000 lozenge in 1 drum of Nicotine Polacrilex, drug for further processing labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The product's dosage form is lozenge and is administered via form.

    Is NDC 0135-1501 included in the NDC Directory?

    Yes, Nicotine Polacrilex is an UNFINISHED PRODUCT with code 0135-1501 that is active and included in the NDC Directory. The product was first marketed by Glaxosmithkline Consumer Healthcare Holdings (us) Llc on June 01, 2022 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 0135-1501-03?

    The 11-digit format is 00135150103. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20135-1501-035-4-200135-1501-03