varenicline
varenicline · KIT · Nivagen Pharmaceuticals Inc.
Varenicline is a prescription medication used to help people quit smoking by reducing cravings and blocking the rewarding effects of nicotine. It comes as a starter kit that is taken by mouth as directed by your doctor.
Key Facts
- Brand Name
- varenicline
- Generic Name
- varenicline
- NDC Code (Product)
75834-336- Manufacturer
- Nivagen Pharmaceuticals Inc.
- Dosage Form
- KIT
- Marketing Status
- Application #
- ANDA217115
- Marketing Start
- 03/02/2026
Recall History
Dr. Reddy's Laboratories, Inc.
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Aidapak Services, LLC
Labeling: Label Mixup: VARENICLINE, Tablet, 0.5 mg may have potentially been mislabeled as one of the following drugs: LACTOBACILLUS GG, Capsule, 0, NDC 49100036374, Pedigree: W003051, EXP: 6/12/2014; SOTALOL HCL, Tablet, 160 mg, NDC 00093106201, Pedigree: AD22609_10, EXP: 4/30/2014; VENLAFAXINE HCL, Tablet, 25 mg, NDC 00093019901, Pedigree: AD62796_4, EXP: 5/22/2014.
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Pfizer Inc.
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Pfizer Inc.
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Pfizer Inc.
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Pfizer Inc.
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Pfizer Inc.
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Pfizer Inc.
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Varenicline tablets are indicated for use as an aid to smoking cessation treatment. Varenicline tablets are a nicotinic receptor partial agonist indicated for use as an aid to smoking cessation treatment. ( 1 and 2.1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Begin varenicline tablets dosing one week before the date set by the patient to stop smoking. Alternatively, the patient can begin varenicline tablets dosing and then quit smoking between days 8 and 35 of treatment. ( 2.1 ) Starting Week: 0.5 mg once daily on days 1 to 3 and 0.5 mg twice daily on days 4 to 7. ( 2.1 ) Continuing Weeks: 1 mg twice daily for a total of 12 weeks. ( 2.1 ) An additional 12 weeks of treatment is recommended for successful quitters to increase likelihood of long-term abstinence. ( 2.1 ) Consider a gradual approach to quitting smoking with varenicline tablets for patients who are sure that they are not able or willing to quit abruptly. Patients should begin varenicline tablets dosing and reduce smoking by 50% from baseline within the first four weeks, by an additional 50% in the next four weeks, and continue reducing with the goal of reaching complete abstinence by 12 weeks. Continue treatment for an additional 12 weeks, for a total of 24 weeks. ( 2.1 ) Severe Renal Impairment (estimated creatinine clearance less than 30 mL/min): Begin with 0.5 mg once daily and titrate to 0.5 mg twice daily. For patients with end-stage renal dis…
Contraindications
4 CONTRAINDICATIONS Varenicline tablets are contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to varenicline tablets. History of serious hypersensitivity or skin reactions to varenicline tablets. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Based on varenicline characteristics and clinical experience to date, varenicline has no clinically meaningful pharmacokinetic drug interactions [see Clinical Pharmacology (12.3) ]. Other Smoking Cessation Therapies: Safety and efficacy in combination with other smoking cessation therapies has not been established. Coadministration of varenicline and transdermal nicotine resulted in a high rate of discontinuation due to adverse events. ( 7.1 ) Effect of Smoking Cessation on Other Drugs: Pharmacokinetics or pharmacodynamics of certain drugs (e.g., theophylline, warfarin, insulin) may be altered, necessitating dose adjustment. ( 7.2 ) 7.1 Use with Other Drugs for Smoking Cessation Safety and efficacy of varenicline in combination with other smoking cessation therapies have not been studied. Bupropion Varenicline (1 mg twice daily) did not alter the steady-state pharmacokinetics of bupropion (150 mg twice daily) in 46 smokers. The safety of the combination of bupropion and varenicline has not been established. Nicotine replacement therapy (NRT) Although co-administration of varenicline (1 mg twice daily) and transdermal nicotine (21 mg/day) for up to 12 days did no…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions were reported in postmarketing experience and are discussed in greater detail in other sections of the labeling: Neuropsychiatric Adverse Events including Suicidality [see Warnings and Precautions (5.1) ] Seizures [see Warnings and Precautions (5.2) ] Interaction with Alcohol [see Warnings and Precautions (5.3) ] Accidental Injury [see Warnings and Precautions (5.4) ] Cardiovascular Events [see Warnings and Precautions (5.5) ] Somnambulism [see Warnings and Precautions (5.6) ] Angioedema and Hypersensitivity Reactions [see Warnings and Precautions (5.7) ] Serious Skin Reactions [see Warnings and Precautions (5.8) ] In the placebo-controlled premarketing studies, the most common adverse events associated with varenicline (>5% and twice the rate seen in placebo-treated patients) were nausea, abnormal (vivid, unusual, or strange) dreams, constipation, flatulence, and vomiting. The treatment discontinuation rate due to adverse events in patients dosed with 1 mg twice daily was 12% for varenicline, compared to 10% for placebo in studies of three months’ treatment. In this group, the discontinuation rates that are higher than pl…
Frequently Asked Questions
What is varenicline used for?
Varenicline is a prescription medication used to help people quit smoking by reducing cravings and blocking the rewarding effects of nicotine. It comes as a starter kit that is taken by mouth as directed by your doctor.
Is varenicline a controlled substance?
varenicline is not classified as a controlled substance by the DEA.
What is the generic name for varenicline?
The generic name for varenicline is varenicline. There are 9 other brand versions of varenicline.
What is the NDC code for varenicline ?
The NDC (National Drug Code) for varenicline is 75834-336, listed by Nivagen Pharmaceuticals Inc..