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  5. NDC Package Code: 0009-5401-01 Nicotrol

NDC Package 0009-5401-01 Nicotrol

Nicotine Spray, Metered Nasal - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

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:
0009-5401-01
Package Description:
4 BOTTLE, SPRAY in 1 BOX / 10 mL in 1 BOTTLE, SPRAY
Product Code:
0009-5401
Proprietary Name:
Nicotrol
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. Using the inhaler can replace the hand-to-mouth habit of smoking. 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:
00009540101
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1797886 - nicotine 0.5 MG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1797888 - Nicotrol 0.5 MG/ACTUAT Metered Dose Nasal Spray
  • RxCUI: 1797888 - nicotine 0.5 MG/ACTUAT Metered Dose Nasal Spray [Nicotrol]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Pharmacia & Upjohn Company Llc
    Dosage Form:
    Spray, Metered - A non-pressurized dosage form consisting of valves which allow the dispensing of a specified quantity of spray upon each activation.
    Administration Route(s):
  • Nasal - Administration to the nose; administered by way of the nose.
    • Active Ingredient(s):
  • NICOTINE 10 mg/mL
    • Pharmacologic Class(es):
  • Cholinergic Nicotinic Agonist - [EPC] (Established Pharmacologic Class)
  • Nicotine - [CS]
    • Sample Package:
    No
    FDA Application Number:
    NDA020385
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    05-22-1996
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    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 0009-5401-01?

    The NDC Packaged Code 0009-5401-01 is assigned to a package of 4 bottle, spray in 1 box / 10 ml in 1 bottle, spray of Nicotrol, a human prescription drug labeled by Pharmacia & Upjohn Company Llc. The product's dosage form is spray, metered and is administered via nasal form.

    Is NDC 0009-5401 included in the NDC Directory?

    Yes, Nicotrol with product code 0009-5401 is active and included in the NDC Directory. The product was first marketed by Pharmacia & Upjohn Company Llc on May 22, 1996 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 NDC billing unit for package 0009-5401-01?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 0009-5401-01?

    The 11-digit format is 00009540101. 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
    4-4-20009-5401-015-4-200009-5401-01