Nicotine Polacrilex

Dr. Reddy's Laboratories Inc.
Human Otc Drug
NDC 43598-484

Nicotine Polacrilex is a drug for further processing labeled by 'Dr. Reddy's Laboratories Inc.'. National Drug Code (NDC) number for Nicotine Polacrilex is 43598-484. This drug is available in dosage form of Lozenge. The names of the active, medicinal ingredients in Nicotine Polacrilex drug includes Nicotine - 2 mg/1 . The currest status of Nicotine Polacrilex drug is Active.

Drug Information:

Drug NDC:	43598-484
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Nicotine Polacrilex
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Nicotine Polacrilex
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Dr. Reddy's Laboratories Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Lozenge
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	NICOTINE - 2 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	11 Sep, 2020
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	09 Jan, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	ANDA212983
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.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Dr. Reddy's Laboratories Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	359817 359818
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
NUI:	N0000175706 M0014836
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	6M3C89ZY6R
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:	Cholinergic Nicotinic Agonist [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class CS:	Nicotine [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Cholinergic Nicotinic Agonist [EPC] Nicotine [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
43598-484-10	4 BOTTLE in 1 CARTON (43598-484-10) / 27 LOZENGE in 1 BOTTLE	11 Sep, 2020	N/A	No
43598-484-12	5 BOTTLE in 1 CARTON (43598-484-12) / 24 LOZENGE in 1 BOTTLE	11 Sep, 2020	N/A	No
43598-484-13	5 BOTTLE in 1 CARTON (43598-484-13) / 27 LOZENGE in 1 BOTTLE	11 Sep, 2020	N/A	No
43598-484-14	6 BOTTLE in 1 CARTON (43598-484-14) / 24 LOZENGE in 1 BOTTLE	11 Sep, 2020	N/A	No
43598-484-16	6 BOTTLE in 1 CARTON (43598-484-16) / 27 LOZENGE in 1 BOTTLE	11 Sep, 2020	N/A	No
43598-484-17	7 BOTTLE in 1 CARTON (43598-484-17) / 24 LOZENGE in 1 BOTTLE	11 Sep, 2020	N/A	No
43598-484-18	7 BOTTLE in 1 CARTON (43598-484-18) / 27 LOZENGE in 1 BOTTLE	11 Sep, 2020	N/A	No
43598-484-19	8 BOTTLE in 1 CARTON (43598-484-19) / 24 LOZENGE in 1 BOTTLE	11 Sep, 2020	N/A	No
43598-484-22	10 BOTTLE in 1 CARTON (43598-484-22) / 24 LOZENGE in 1 BOTTLE	11 Sep, 2020	N/A	No
43598-484-23	8 BOTTLE in 1 CARTON (43598-484-23) / 27 LOZENGE in 1 BOTTLE	11 Sep, 2020	N/A	No
43598-484-24	1 BOTTLE in 1 CARTON (43598-484-24) / 24 LOZENGE in 1 BOTTLE	11 Sep, 2020	N/A	No
43598-484-27	1 BOTTLE in 1 CARTON (43598-484-27) / 27 LOZENGE in 1 BOTTLE	11 Sep, 2020	N/A	No
43598-484-29	10 BOTTLE in 1 CARTON (43598-484-29) / 27 LOZENGE in 1 BOTTLE	11 Sep, 2020	N/A	No
43598-484-48	2 BOTTLE in 1 CARTON (43598-484-48) / 24 LOZENGE in 1 BOTTLE	11 Sep, 2020	N/A	No
43598-484-54	2 BOTTLE in 1 CARTON (43598-484-54) / 27 LOZENGE in 1 BOTTLE	11 Sep, 2020	N/A	No
43598-484-72	3 BOTTLE in 1 CARTON (43598-484-72) / 24 LOZENGE in 1 BOTTLE	11 Sep, 2020	N/A	No
43598-484-73	7 BOTTLE in 1 CARTON (43598-484-73) / 24 LOZENGE in 1 BOTTLE	11 Sep, 2020	N/A	No
43598-484-74	7 BOTTLE in 1 CARTON (43598-484-74) / 27 LOZENGE in 1 BOTTLE	11 Sep, 2020	N/A	No
43598-484-81	3 BOTTLE in 1 CARTON (43598-484-81) / 27 LOZENGE in 1 BOTTLE	11 Sep, 2020	N/A	No
43598-484-96	4 BOTTLE in 1 CARTON (43598-484-96) / 24 LOZENGE in 1 BOTTLE	11 Sep, 2020	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Purpose:

Purpose stop smoking aid

Product Elements:

Nicotine polacrilex nicotine polacrilex nicotine nicotine polacrilin acacia glycerin mentha arvensis leaf oil magnesium stearate mannitol menthol peppermint oil potassium bicarbonate sodium alginate sodium carbonate sucralose triacetin xanthan gum white to off white n484 nicotine polacrilex nicotine polacrilex nicotine nicotine polacrilin acacia glycerin mentha arvensis leaf oil magnesium stearate mannitol menthol peppermint oil potassium bicarbonate sodium alginate sodium carbonate sucralose triacetin xanthan gum white to off white n485 pic1 pic2 figure container1 container2 carton1 carton2

Indications and Usage:

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

Warnings:

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 o Read more...

f 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).

Dosage and Administration:

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 users 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 Read more...

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 users 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 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.

Stop Use:

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)

Package Label Principal Display Panel:

Principal display panel nicotine polacrilex lozenge, 2 mg - container

Nicotine polacrilex lozenge, 2 mg - container carton

Nicotine polacrilex lozenge, 4 mg - container

Nicotine polacrilex lozenge, 4 mg - container carton

Further Questions:

Questions or comments? call toll-free 1-800-585-8682 weekdays (9:00 am to 8:00 pm est) distributed by: dr. reddys laboratories, inc. princeton, nj 08540 made in denmark issued: 0220

Comments/ Reviews:

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