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  5. NDC Package Code: 58316-007-01 Nicotine

NDC Package 58316-007-01 Nicotine

Patch, Extended Release - 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:
58316-007-01
Package Description:
6300 POUCH in 1 CARTON / 1 PATCH in 1 POUCH / 24 h in 1 PATCH
Product Code:
58316-007
Non-Proprietary Name:
Nicotine
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:
58316000701
Product Type:
Drug For Further Processing
Labeler Name:
Glaxosmithkline Dungarvan Limited
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).
Active Ingredient(s):
  • NICOTINE 14 mg/24h
    • 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 58316-007-01?

    The NDC Packaged Code 58316-007-01 is assigned to an UNFINISHED drug package of 6300 pouch in 1 carton / 1 patch in 1 pouch / 24 h in 1 patch of Nicotine, drug for further processing labeled by Glaxosmithkline Dungarvan Limited. The product's dosage form is patch, extended release and is administered via form.

    Is NDC 58316-007 included in the NDC Directory?

    Yes, Nicotine is an UNFINISHED PRODUCT with code 58316-007 that is active and included in the NDC Directory. The product was first marketed by Glaxosmithkline Dungarvan Limited 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 58316-007-01?

    The 11-digit format is 58316000701. 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 5-3-2 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
    5-3-258316-007-015-4-258316-0007-01