Simvastatin
Product Images NDC 13107-053

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Simvastatin (NDC 13107-053). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurolife Pharma Llc, 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

Package Label.principal Display Panel (40mg (2000 Tablets Bottle NCRC))

Simvastatin Tablets USP 40 mg label showing a package of 2000 tablets. The label includes storage instructions, pharmacist dispensing info, and manufacturer details for Aurolife Pharma LLC and Aurobindo Pharma USA, Inc. The label also cites the NDC 13107-053-22 and states 'Rx only.'*

FDA Label Image

Simvastatin Figure-1 (Simvastatin Fig1)

A comparative risk ratio chart depicting Major Vascular Events and Major Coronary Events incidence in patients treated with Simvastatin versus placebo. The left panel shows incidence percentages and risk ratios for Major Vascular Events across various patient subgroups, while the right panel similarly presents data for Major Coronary Events. Risk ratios with 95% confidence intervals are plotted to show favorability towards Simvastatin or placebo.*

FDA Label Image

Package Label.principal Display Panel (5mg (2500 Tablets Bottle NCRC))

Simvastatin Tablets USP 5 mg label showing a package of 2500 tablets. The label includes storage instructions and pharmacist dispensing guidelines. It states the drug is manufactured by Aurolife Pharma LLC and for Aurobindo Pharma USA, Inc. The label also includes an NDC number and ordering information.*

FDA Label Image

Package Label.principal Display Panel (10mg (2500 Tablets Bottle NCRC))

Simvastatin Tablets, USP 10 mg film-coated tablets label showing a package of 2500 tablets. Manufactured by Aurolife Pharma LLC, Dayton, NJ, and for Aurobindo Pharma USA, Inc. Includes storage instructions, pharmacist dispensing requirements, and the Rx only designation. The label features the Aurobindo logo at the bottom.*

FDA Label Image

Package Label.principal Display Panel (20mg (2500 Tablets Bottle NCRC))

Simvastatin Tablets, USP 20 mg label showing a package of 2500 tablets. The product is manufactured by Aurolife Pharma LLC and labeled for Aurobindo Pharma USA, Inc. Storage instructions recommend keeping tablets at 20° to 25°C with allowance for excursions. Barcode and batch/expiry placeholders are also visible.*

FDA Label Image

Package Label.principal Display Panel (80mg (1000 Tablets Bottle NCRC))

Simvastatin Tablets USP 80 mg film-coated tablets, packaged in a container of 1000 tablets. Manufactured by Aurolife Pharma LLC, Dayton, NJ, and for Aurobindo Pharma USA, Inc. Label includes storage instructions, dosage note advising to see package insert, pharmacist dispensing instructions, batch and expiry placeholders, and a barcode.*

FDA Label Image

Simvastatin Chemical Structure (Simvastatin Str)

Chemical structure of simvastatin, showing the arrangement of carbon, hydrogen, and oxygen atoms in the molecule. The structure features a hexahydronaphthalene ring and a lactone ring with hydroxyl and keto functional 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.