Nicotine Transdermal System Patch, Extended Release
NDC 46122-832

Nicotine 14 mg/24h · Patch, Extended Release (transdermal)
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 46122-832?
  4. Nicotine Transdermal System Step 2 Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes

Product Information

Nicotine Transdermal System (nicotine) is a NDA-approved product labeled by Amerisourcebergen Drug Corporation. This medication is typically used as a cholinergic nicotinic agonist [epc]. It is supplied as a patch, extended release for transdermal administration. This product entry covers the primary NDC 46122-832 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
46122-832
Proprietary Name:
Nicotine Transdermal System Step 2
Non-Proprietary Name: [1]
Nicotine
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:
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).
Administration Route(s): [4]
Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.

Labeler & Regulatory Data

Labeler Name: [5]
Amerisourcebergen Drug Corporation
Labeler Code:
46122
Product Label ID:
e51d2c09-a20f-eb9b-e3e4-013f3e488ab3
FDA Application Number: [6]
NDA020076
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
07-01-2026
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 46122-832?

The NDC code 46122-832 is assigned by the FDA to the product Nicotine Transdermal System Step 2. It is commonly known by its generic name, nicotine. This pharmaceutical product is labeled by Amerisourcebergen Drug Corporation and is currently categorized as listed product. The medication is a patch, extended release administered via transdermal route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 46122-832-45. 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 use•before using this product, read the enclosed self-help guide for complete directions and other information•begin using the patch on your quit day•if you smoke more than 10 cigarettes per day, use the following schedule below: Weeks 1 thru 4Weeks 5 and 6Weeks 7 and 8STEP 1STEP 2STEP 3Use one 21 mg patch/dayUse one 14 mg patch/dayUse one 7 mg patch/day•if you smoke 10 or less cigarettes per day, start with Step 2 for 6 weeks, then Step 3 for 2 weeks •apply one new patch every 24 hours on skin that is dry, clean and hairless•remove backing from patch and immediately press onto skin. Hold for 10 seconds.•wash hands after applying or removing patch. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch. •the used patch should be removed and a new one applied to a different skin site at the same time each day•if you have vivid dreams, you may remove the patch at bedtime and apply a new one in the morning•do not wear more than one patch at a time•do not cut patch in half or into smaller pieces•do not leave patch on for more than 24 hours because it may irritate your skin and loses strength after 24 hours•to avoid possible burns, remove patch before undergoing any MRI (magnetic resonance imaging) procedures•It is important to complete treatment. If you feel you need to use the patch 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 14 mg/24h - 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 associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated 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. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

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:

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".