Nicotine Polacrilex Gum, Chewing
NDC 50090-8146
Nicotine 4 mg/1 · Gum, Chewing (oral)
Product Information
Nicotine Polacrilex is a ANDA-approved product labeled by A-s Medication Solutions. This medication is typically used as a cholinergic nicotinic agonist [epc]. It is supplied as a gum, chewing for oral administration. This product entry covers the primary NDC 50090-8146 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
50090-8146
Proprietary Name:
Nicotine Polacrilex
Non-Proprietary Name: [1]
Nicotine Polacrilex
Substance Name: [2]
Nicotine
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Gum, Chewing
- A sweetened and flavored insoluble plastic material of various shapes which when chewed, releases a drug substance into the oral cavity.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
50090
Product Label ID:
FDA Application Number: [6]
ANDA078697
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
08-10-2023
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 50090-8146?
The NDC code 50090-8146 is assigned by the FDA to the product Nicotine Polacrilex. This pharmaceutical product is labeled by A-s Medication Solutions and is currently categorized as listed product. The medication is a gum, chewing administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 50090-8146-0. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
If you are under 18 years of age, ask a doctor before usebefore using this product, read the enclosed User's Guide for complete directions and other important informationbegin using the gum on your quit dayif you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine gumif you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine gum according to the following 12 week schedule:Weeks 1 to 6Weeks 7 to 9Weeks 10 to 12 1 piece every1 to 2 hours1 piece every2 to 4 hours 1 piece every4 to 8 hours nicotine gum is a medicine and must be used a certain way to get the best resultschew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns.repeat this process until most of the tingle is gone (about 30 minutes)do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a pieceto improve your chances of quitting, use at least 9 pieces per day for the first 6 weeksif you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects.do not use more than 24 pieces a dayit is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider.
What are Active Ingredients of this product?
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.
Which are the Pharmacologic Classes of this product?
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 full disclaimer at the bottom of this page.
Product & Regulatory Definitions
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.
What is the Substance Name? 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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
