Drugplain

Nicotine Transdermal System Patch Step 1 21 mg/24h

Nicotine Transdermal System Patch · PATCH, EXTENDED RELEASE · BluePoint Laboratories

No Recall History
Plain English

Nicotine Transdermal System Patch Step 1 is a patch, extended release containing nicotine transdermal system patch at 21 mg/24h, taken transdermal. Manufactured by BluePoint Laboratories.

Key Facts

Brand Name
Nicotine Transdermal System Patch Step 1
Generic Name
Nicotine Transdermal System Patch
NDC Code (Product)
68001-699
Manufacturer
BluePoint Laboratories
Strength
21 mg/24h
Dosage Form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Marketing Status
Application #
NDA020076
Drug Class
Cholinergic Nicotinic Agonist [EPC]
Marketing Start
05/11/2026

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

counterfeit product administered1 reports
palpitations1 reports
product label issue1 reports
therapeutic product effect increased1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

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 reson

Warnings

WARNINGS SECTION 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 rashirregular heartbeat or p

Frequently Asked Questions

What is Nicotine Transdermal System Patch Step 1 used for?

Nicotine Transdermal System Patch Step 1 contains Nicotine Transdermal System Patch. It is a patch, extended release taken transdermal. Consult your doctor for specific uses.

Is Nicotine Transdermal System Patch Step 1 a controlled substance?

Nicotine Transdermal System Patch Step 1 is not classified as a controlled substance by the DEA.

What is the generic name for Nicotine Transdermal System Patch Step 1?

The generic name for Nicotine Transdermal System Patch Step 1 is Nicotine Transdermal System Patch. There are 5 other brand versions of Nicotine Transdermal System Patch.

What is the NDC code for Nicotine Transdermal System Patch Step 1 21 mg/24h?

The NDC (National Drug Code) for Nicotine Transdermal System Patch Step 1 21 mg/24h is 68001-699, listed by BluePoint Laboratories.

Product NDC

68001-699

Package NDC

68001-699-88

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)