Drugplain

Nicotine Transdermal System 7 mg/24h

Nicotine Transdermal System · PATCH, EXTENDED RELEASE · AmerisourceBergen Drug Corporation

1 Recall on Record
Plain English

Nicotine Transdermal System is a patch, extended release containing nicotine transdermal system at 7 mg/24h, taken transdermal. Manufactured by AmerisourceBergen Drug Corporation.

Key Facts

Brand Name
Nicotine Transdermal System
Generic Name
Nicotine Transdermal System
NDC Code (Product)
46122-354
Manufacturer
AmerisourceBergen Drug Corporation
Strength
7 mg/24h
Dosage Form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Marketing Status
Application #
ANDA074612
Drug Class
Cholinergic Nicotinic Agonist [EPC]
Marketing Start
06/25/2024

Recall History

1 Recall on Record
Class III05/14/2026

AVEVA Drug Delivery Systems, Inc.

Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective1,730 reports
nausea1,078 reports
product adhesion issue905 reports
overdose771 reports
headache758 reports
nicotine dependence752 reports
foetal exposure during pregnancy745 reports
treatment noncompliance679 reports
dyspnoea628 reports
pain627 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: Weeks 1 thru 4 Weeks 5 and 6 Weeks 7 and 8 STEP 1 STEP 2 STEP 3 use one 21 mg patch/day use one 14 mg patch/day use 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…

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 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 the 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…

Frequently Asked Questions

What is Nicotine Transdermal System used for?

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

Is Nicotine Transdermal System a controlled substance?

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

What is the generic name for Nicotine Transdermal System?

The generic name for Nicotine Transdermal System is Nicotine Transdermal System. There are 2 other brand versions of Nicotine Transdermal System.

What is the NDC code for Nicotine Transdermal System 7 mg/24h?

The NDC (National Drug Code) for Nicotine Transdermal System 7 mg/24h is 46122-354, listed by AmerisourceBergen Drug Corporation.

Product NDC

46122-354

Package NDC

46122-354-74

Other Nicotine Brands

See all →

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

Data from openFDA · Public domain (CC0 1.0)