Varenicline Tartrate Tablet, Film Coated
Product Images NDC 42571-459

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Varenicline Tartrate (NDC 42571-459). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Micro Labs 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

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This description provides details of a film-coated tablet containing varenicline tartrate equivalent to varenicline free base. The dosage instructions, storage conditions, manufacturing details, and dispensing information are also mentioned. Furthermore, it specifies the quantity of tablets in the container and the expiration date of the product.*
FDA Label Image

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Varenicline-1mglbl.jpg (Varenicline 1mglbl)
This text provides information about varenicline tablets, with each tablet containing 1.71 mg of varenicline tartrate, equivalent to 1 mg of varenicline free base. The usual dosage and storage instructions are not provided, with a recommendation to refer to the accompanying prescribing information for details. The tablets should be stored at 20°C to 25°C, with excursions permitted within a specific temperature range. They should be dispensed in tight, child-resistant containers and kept at 15°C to 30°C. The manufacturer is identified as Micro Labs Limited in India, and the medication guide is for distribution in the USA. The National Drug Code (NDC) for the tablets is provided for identification purposes.*
FDA Label Image

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Varenicline-contpck460.jpg (Varenicline Contpck460)
This is a product description for Varenicline tablets in a continuing pack. The product has an NDC code of 42571-460-88 and contains multiple tablets. The quantity appears to be 10000000 tablets.*
FDA Label Image

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Varenicline-contpck4601.jpg (Varenicline Contpck4601)
This text seems to be a medication label for Varenicline Tablets providing information on a continuing month box for the next 4 weeks. It includes details on dispensing the accompanying Medication Guide to each patient and specifies the contents as 4 Continuing Weeks (1 mg x 56 tablets). The label also provides the NDC code as 42571-460-88 and specifies "Rx only".*
FDA Label Image

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FDA Label Image

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FDA Label Image

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Varenicline-figc.jpg (Varenicline Figc)
This text appears to be a medication dosing schedule and data related to continuous abstinence rates at different time points. The medication mentioned is VarenicinoTablets 10mg, with a dosing instruction of "BID" (twice daily), and it is compared to a placebo. The data seems to represent continuous abstinence percentages at month 3 and week 4 of treatment. Additionally, there is a reference to non-treatment follow-up in weeks.*
FDA Label Image

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FDA Label Image

Varenicline-strpck475.jpg (Varenicline Strpck475)

Varenicline-strpck475.jpg (Varenicline Strpck475)
This is a description of Varenicline Tablets, a prescription medication used for smoking cessation. It comes in film-coated tablets containing varenicline tartrate. Each tablet contains a specific amount of varenicline equivalent to a different dose of the active ingredient. The recommended dosage and storage information are provided. The medication should be started with the Starting Week blister card before moving on to the Continuing Weeks. The tablets are manufactured by Micro Labs USA, Inc. and come with an accompanying Medication Guide for patients.*
FDA Label Image

Varenicline-strpck4751.jpg (Varenicline Strpck4751)

Varenicline-strpck4751.jpg (Varenicline Strpck4751)
This text provides detailed information about varenicline tablets, including the dosage instructions for the first 28 days of use, the composition of each tablet, storage instructions, and manufacturing details. It also mentions the accompanying Medication Guide and the process of dispensing it to each patient by the pharmacist. Additionally, it includes a starting month box content description and a reference to the NDC number for the product.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.