NDC 43598-485 Nicotine Polacrilex
Lozenge Oral

Product Information

What is NDC 43598-485?

The NDC code 43598-485 is assigned by the FDA to the product Nicotine Polacrilex which is a human over the counter drug product labeled by Dr. Reddy's Laboratories Inc.. The product's dosage form is lozenge and is administered via oral form. The product is distributed in 20 packages with assigned NDC codes 43598-485-10 4 bottle in 1 carton / 27 lozenge in 1 bottle, 43598-485-12 5 bottle in 1 carton / 24 lozenge in 1 bottle, 43598-485-13 5 bottle in 1 carton / 27 lozenge in 1 bottle, 43598-485-14 6 bottle in 1 carton / 24 lozenge in 1 bottle, 43598-485-16 6 bottle in 1 carton / 27 lozenge in 1 bottle, 43598-485-17 7 bottle in 1 carton / 24 lozenge in 1 bottle, 43598-485-18 7 bottle in 1 carton / 27 lozenge in 1 bottle, 43598-485-19 8 bottle in 1 carton / 24 lozenge in 1 bottle, 43598-485-22 10 bottle in 1 carton / 24 lozenge in 1 bottle, 43598-485-23 8 bottle in 1 carton / 27 lozenge in 1 bottle, 43598-485-24 1 bottle in 1 carton / 24 lozenge in 1 bottle, 43598-485-27 1 bottle in 1 carton / 27 lozenge in 1 bottle, 43598-485-29 10 bottle in 1 carton / 27 lozenge in 1 bottle, 43598-485-48 2 bottle in 1 carton / 24 lozenge in 1 bottle, 43598-485-54 2 bottle in 1 carton / 27 lozenge in 1 bottle, 43598-485-72 3 bottle in 1 carton / 24 lozenge in 1 bottle, 43598-485-73 7 bottle in 1 carton / 24 lozenge in 1 bottle, 43598-485-74 7 bottle in 1 carton / 27 lozenge in 1 bottle, 43598-485-81 3 bottle in 1 carton / 27 lozenge in 1 bottle, 43598-485-96 4 bottle in 1 carton / 24 lozenge in 1 bottle. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code43598-485
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Nicotine Polacrilex
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Nicotine Polacrilex
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Otc Drug
Dosage FormLozenge - 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(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Dr. Reddy's Laboratories Inc.
Labeler Code43598
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
ANDA212983
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
09-11-2020
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2023
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Nicotine Polacrilex?


Product Characteristics

Color(s)WHITE (C48325 - WHITE TO OFF WHITE)
ShapeROUND (C48348)
Size(s)16 MM
Imprint(s)N484
N485
Score1

Product Packages

NDC Code 43598-485-10

Package Description: 4 BOTTLE in 1 CARTON / 27 LOZENGE in 1 BOTTLE

NDC Code 43598-485-12

Package Description: 5 BOTTLE in 1 CARTON / 24 LOZENGE in 1 BOTTLE

NDC Code 43598-485-13

Package Description: 5 BOTTLE in 1 CARTON / 27 LOZENGE in 1 BOTTLE

NDC Code 43598-485-14

Package Description: 6 BOTTLE in 1 CARTON / 24 LOZENGE in 1 BOTTLE

NDC Code 43598-485-16

Package Description: 6 BOTTLE in 1 CARTON / 27 LOZENGE in 1 BOTTLE

NDC Code 43598-485-17

Package Description: 7 BOTTLE in 1 CARTON / 24 LOZENGE in 1 BOTTLE

NDC Code 43598-485-18

Package Description: 7 BOTTLE in 1 CARTON / 27 LOZENGE in 1 BOTTLE

NDC Code 43598-485-19

Package Description: 8 BOTTLE in 1 CARTON / 24 LOZENGE in 1 BOTTLE

NDC Code 43598-485-22

Package Description: 10 BOTTLE in 1 CARTON / 24 LOZENGE in 1 BOTTLE

NDC Code 43598-485-23

Package Description: 8 BOTTLE in 1 CARTON / 27 LOZENGE in 1 BOTTLE

NDC Code 43598-485-24

Package Description: 1 BOTTLE in 1 CARTON / 24 LOZENGE in 1 BOTTLE

NDC Code 43598-485-27

Package Description: 1 BOTTLE in 1 CARTON / 27 LOZENGE in 1 BOTTLE

NDC Code 43598-485-29

Package Description: 10 BOTTLE in 1 CARTON / 27 LOZENGE in 1 BOTTLE

NDC Code 43598-485-48

Package Description: 2 BOTTLE in 1 CARTON / 24 LOZENGE in 1 BOTTLE

NDC Code 43598-485-54

Package Description: 2 BOTTLE in 1 CARTON / 27 LOZENGE in 1 BOTTLE

NDC Code 43598-485-72

Package Description: 3 BOTTLE in 1 CARTON / 24 LOZENGE in 1 BOTTLE

NDC Code 43598-485-73

Package Description: 7 BOTTLE in 1 CARTON / 24 LOZENGE in 1 BOTTLE

NDC Code 43598-485-74

Package Description: 7 BOTTLE in 1 CARTON / 27 LOZENGE in 1 BOTTLE

NDC Code 43598-485-81

Package Description: 3 BOTTLE in 1 CARTON / 27 LOZENGE in 1 BOTTLE

NDC Code 43598-485-96

Package Description: 4 BOTTLE in 1 CARTON / 24 LOZENGE in 1 BOTTLE

Product Details

What are Nicotine Polacrilex Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • NICOTINE 4 mg/1 - Nicotine is highly toxic alkaloid. It is the prototypical agonist at nicotinic cholinergic receptors where it dramatically stimulates neurons and ultimately blocks synaptic transmission. Nicotine is also important medically because of its presence in tobacco smoke.

Nicotine Polacrilex Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Nicotine Polacrilex Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Nicotine Polacrilex Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Active Ingredients (In Each Lozenge)



Nicotine polacrilex, 2 mg

Nicotine polacrilex, 4 mg


Purpose



Stop smoking aid


Use



  • reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

Warnings



If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.


Ask A Doctor Before Use If You Have



  • a sodium-restricted diet
  • heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.
  • high blood pressure not controlled with medication. Nicotine can increase your blood pressure.
  • stomach ulcer or diabetes
  • history of seizures

Ask A Doctor Or Pharmacist Before Use If You Are



  • using a non-nicotine stop smoking drug
  • taking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.

Stop Use And Ask Doctor If



  • mouth problems occur
  • persistent indigestion or severe sore throat occurs
  • irregular heartbeat or palpitations occur
  • you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat
  • you have symptoms of an allergic reaction (such as difficulty breathing or rash)

Keep Out Of Reach Of Children And Pets



Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).


Directions



2 mg:

  • 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 6 Weeks 7 to 9 Weeks 10 to 12
    1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 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 (about 20-30 minutes). 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 (about 20-30 minutes)
    • 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.
    • 4 mg:

      • 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 more than 30 minutes after waking up, use 2 mg nicotine lozenge
      • if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge according to the following 12 week schedule:
      • Weeks 1 to 6Weeks 7 to 9Weeks 10 to 12
        1 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 (about 20-30 minutes). 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 (about 20-30 minutes)
        • 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.

Other Information



  • each lozenge contains: sodium, 17 mg
  • store at 20 – 25°C (68 – 77°F)
  • keep container tightly closed and protect from light

Inactive Ingredients



acacia, corn mint oil, flavor, magnesium stearate, mannitol, menthol, peppermint oil, potassium bicarbonate, sodium alginate, sodium carbonate anhydrous, sucralose, triacetin and xanthan gum.


Questions Or Comments?



call toll-free 1-800-585-8682 weekdays (9:00 am to 8:00 pm EST)

Distributed by:

Dr. Reddy’s Laboratories, Inc.

Princeton, NJ 08540

Made in Denmark

Issued: 0220


Principal Display Panel



Nicotine Polacrilex Lozenge, 2 mg - Container


* Please review the disclaimer below.