NDC 55741-448 Habitrol Step 1
Nicotine Transdermal System Patch Patch, Extended Release Transdermal

Product Information

Product Code55741-448
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.
Habitrol Step 1
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 Transdermal System Patch
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 FormPatch, 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) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
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 Code55741
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.
NDA020076
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.
NDA - A product marketed under an approved 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.
07-13-2018
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.
12-31-2022
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

Usage Information


Product Packages

NDC 55741-448-28

Package Description: 28 PATCH in 1 CARTON > 24 h in 1 PATCH

NDC 55741-448-70

Package Description: 7 PATCH in 1 CARTON > 24 h in 1 PATCH

NDC 55741-448-74

Package Description: 14 PATCH in 1 CARTON > 24 h in 1 PATCH

Product Details

Habitrol Step 1 is a human over the counter drug product labeled by Dr. Reddy's Laboratories Inc.. The generic name of Habitrol Step 1 is nicotine transdermal system patch. The product's dosage form is patch, extended release and is administered via transdermal form.


What are Habitrol Step 1 Active Ingredients?

The following is the list of active ingredients in 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.


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:


Inactive Ingredient(s)

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.

  • METHACRYLIC ACID (UNII: 1CS02G8656)


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.

Patient Education

Nicotine Transdermal Patch

Nicotine Transdermal Patch is pronounced as (nik' oh teen)

Why is nicotine transdermal patch medication prescribed?
Nicotine skin patches are used to help people stop smoking cigarettes. They provide a source of nicotine that reduces the withdrawal symptoms experienced when smoking is ...
[Read More]

* Please review the disclaimer below.

Habitrol Step 1 Labeling and Warnings

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.

Table of Contents



Active Ingredient Step 1 (In Each Patch)



Nicotine, 21 mg delivered over 24 hours


Active Ingredient Step 2 (In Each Patch)



Nicotine, 14 mg delivered over 24 hours


Active Ingredient Step 3 (In Each Patch)



Nicotine, 7 mg delivered over 24 hours


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



  • 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.
  • an allergy to adhesive tape or have skin problems, because you are more likely to get rashes.
  • 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 a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.

When Using This Product



  • •if you have vivid dreams or other sleep disturbances remove this patch at bedtime

Stop Use And Ask A Doctor If



  • skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rash
  • irregular heartbeat or palpitations occur
  • you get symptoms of nicotine overdose, such as nausea, vomiting, dizziness, 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.



Used patches have enough nicotine to poison children and pets. If swallowed, get medical help or contact a Poison Control Center right away. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch.


Directions



  • 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:
    • •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.

Other Information



store at 20-25°C (68-77°F)


Inactive Ingredients



acrylate adhesive, aluminized polyester, cellulose paper, methacrylic acid copolymer


Questions Or Comments?



call 1-800-585-8682

Weekdays (9am-8pm ET) or visit us at www.habitrol.com

TO INCREASE YOUR SUCCESS IN QUITTING:

1. You must be motivated to quit.

2. Use one patch daily according to directions.

3. It is important to complete treatment.

4. If you feel you need to use the patch for a longer period to keep from smoking, talk to your health care provider.

5. Use patch with a behavioural support program, such as the one described in the enclosed booklet.

For your family's protection, patches are supplied in child-resistant pouches. Do not use if individual pouch is open or torn.

  • Not for sale to persons under 18 years of age.
  • Proof of age required.
  • Not for sale in vending machines or from any source where proof of age cannot be verified.

Principal Display Panel



NDC 55741-448-74

Habitrol®Take Control™ Support Program


Nicotine Transdermal System Patch

21 mg delivered over 24 hours

STOP SMOKING AID

21 mg

Includes:
Behavior Support
Program with

self-help guide

STEP 1

IF YOU SMOKE MORE THAN 10 CIGARETTES PER DAY: START WITH STEP 1

IF YOU SMOKE 10 OR LESS CIGARETTES PER DAY: START WITH STEP 2

14 Patches
(2 Week Kit)

The full treatment course for Step 1 is 28
patches (4 weeks); this package contains 14
patches (2 week course) only. Read the enclosed
self-help guide for additional information.

NDC 55741-447-74

Habitrol® Take Control™ Support Program


Nicotine Transdermal System Patch

14 mg delivered over 24 hours

STOP SMOKING AID

14 mg

Includes:
Behavior Support
Program with

self-help guide

STEP 2

IF YOU SMOKE MORE THAN 10 CIGARETTES PER DAY: USE AFTER COMPLETING STEP 1

IF YOU SMOKE 10 OR LESS CIGARETTES PER DAY: START WITH STEP 2

14 Patches
(2 Week Kit)

NDC 55741-446-74

Habitrol® Take Control™ Support Program
Nicotine Transdermal System Patch

7 mg delivered over 24 hours

STOP SMOKING AID

7 mg

Includes:
Behavior Support
Program with

self-help guide

STEP 3

FOR USE AFTER COMPLETING STEP 2

14 Patches
(2 Week Kit)


* Please review the disclaimer below.