Varenicline Tablet, Film Coated
Product Images NDC 59651-418

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Varenicline (NDC 59651-418). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma Limited, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Varenicline-fig1.jpg (Varenicline Fig1)

A bar chart titled 'Continuous Abstinence, Weeks 9 through 12' showing results from five studies comparing different dosages and formulations of Varenicline and placebo. The y-axis represents percentage abstinence from 0% to 60%. Study 2 compares Varenicline 0.5 mg BID, 1 mg BID, and placebo; Study 3 compares Varenicline Flexible and placebo; Study 4 compares Varenicline 1 mg BID, Bupropion SR 150 mg BID, and placebo; Study 5 compares Varenicline 1 mg BID, Bupropion SR 150 mg BID, and placebo. Bars show variable abstinence rates with Varenicline generally higher than placebo across studies.*

FDA Label Image

Package Label-principal Display Panel (1 mg Continuing Month Box Carton)

Packaging label for Varenicline Tablets Continuing Month Box by Aurobindo Pharma Limited. The label specifies 4 continuing weeks supply with 1 mg tablets, totaling 56 tablets. The label includes storage instructions, distributor details for Aurobindo Pharma USA, Inc., and directs pharmacists to provide the Medication Guide separately.*

FDA Label Image

Package Label-principal Display Panel (1 mg x 56 Tablet Continuing Pack)

Varenicline Tablets continuing pack label from Aurobindo Pharma Limited. The packaging is for oral film-coated tablets with strengths of 0.5 mg and 1 mg. The label indicates the pack contains 4 cartons for a total of 56 tablets, with directions for pharmacists to dispense a Medication Guide separately to patients. The label includes NDC 59651-418-55 and standard pharmaceutical labeling elements.*

FDA Label Image

Varenicline-fig2.jpg (Varenicline Fig2)

A bar graph titled 'Figure 2: Continuous Abstinence, Weeks 9 through 52' comparing the percentage of continuous abstinence in different treatment groups across four clinical studies. The groups include Varenicline 0.5 mg BID, Varenicline 1 mg BID, Placebo, Varenicline Flexible dose, Bupropion SR 150 mg BID, and their respective Placebo controls. The y-axis shows percentage abstinence from 0% to 35%.*

FDA Label Image

Varenicline-fig3.jpg (Varenicline Fig3)

Line chart titled 'Continuous Abstinence Rate during Nontreatment Follow-Up' comparing Varenicline 1 mg BID and placebo. The X-axis shows nontreatment follow-up in weeks, and the Y-axis shows percentage continuous abstinent. The chart depicts a higher continuous abstinence rate over time for Varenicline compared to placebo.*

FDA Label Image

Figure 4 (Varenicline Fig4)

A table presenting a stepwise smoking reduction plan over 12 weeks for patients. Weeks 1 through 4 advise reducing smoking to half the starting daily number of cigarettes, with an example for 20 cigarettes reduced to 10. Weeks 5 through 8 recommend reducing smoking to one-quarter of the starting number, with an example for 20 cigarettes reduced to 5. Weeks 9 through 12 encourage continuing to reduce smoking until complete cessation (zero cigarettes).*

FDA Label Image

Figure 5 (Varenicline Fig5)

A dosing schedule table for Varenicline tablets. It lists intake instructions by treatment days: Day 1-3, a white 0.5 mg tablet once daily; Day 4-7, white 0.5 mg tablets twice daily; Day 8 onward, light blue 1 mg tablets twice daily. Dosage form and strengths are specified.*

FDA Label Image

Package Label-principal Display Panel (0.5 mg Container Label (56 Tablets Bottle))

Label for Varenicline Tablets 0.5 mg, film-coated oral tablets. The label includes dosage information, storage instructions, and states the product is distributed by Aurobindo Pharma USA, Inc. It indicates a package size of 56 tablets and references medication guides. The label features the Aurobindo logo and an NDC barcode.*

FDA Label Image

Package Label-principal Display Panel (0.5 mg and 1 mg Tablet Starting Month Box Carton)

Varenicline Tablets Starting Month Box packaging label from Aurobindo Pharma Limited. The box contains film-coated oral tablets for human prescription use, including 0.5 mg strength tablets for the first week (11 tablets) and 1 mg strength tablets for the following three weeks (42 tablets). Label includes dosage instructions and distributor Aurobindo Pharma USA, Inc.*

FDA Label Image

Package Label-principal Display Panel (Starting Pack)

Varenicline Tablets Starting Pack carton label from Aurobindo Pharma Limited. The packaging displays dosing instructions for a starter regimen including 0.5 mg tablets for the first week. The label indicates a prescription human drug in oral film-coated tablet form. The pack contains blister cards arranged for a 3-week dosing schedule with daily morning and evening tablets.*

FDA Label Image

Package Label-principal Display Panel (1 mg Container Label (56 Tablets Bottle))

Varenicline Tablets 1 mg film-coated oral tablets label from Aurobindo Pharma. The label includes NDC 59651-418-56, storage instructions, distributor information (Aurobindo Pharma USA, Inc.), and a note to pharmacists to dispense the Medication Guide with the 56-count package. The label specifies the equivalent amount of varenicline tartrate and indicates manufacturing in India.*

FDA Label Image

Structure (Varenicline Str)

Chemical structure diagram of varenicline, showing molecular components including a bicyclic system with nitrogen atoms and a stereochemical center represented by R groups and functional groups such as hydroxyl and carboxyl groups.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.