Atorvastatin Calcium Tablet, Film Coated
Product Images NDC 16729-046

8 FDA label images from Accord Healthcare Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Atorvastatin Calcium (NDC 16729-046). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Accord Healthcare Inc., 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

Atorvastatin Calcium Tablets – 10 mg 30 Bottle Label (Atorvastatin 10 mg 30 Bottle Label)

Atorvastatin Calcium Tablets – 10 mg 30 Bottle Label (Atorvastatin 10 mg 30 Bottle Label)
Label for Atorvastatin Calcium Tablets USP 10 mg by Accord Healthcare Inc. The film-coated tablets are packaged in a bottle containing 30 tablets. The label provides storage instructions, manufacturer details, and a barcode, with emphasis on the 10 mg strength in pink.*
FDA Label Image

Atorvastatin Calcium Tablets – 20 mg 30 Bottle Carton (Atorvastatin 20 mg 30 Bottle Label)

Atorvastatin Calcium Tablets – 20 mg 30 Bottle Carton (Atorvastatin 20 mg 30 Bottle Label)
Label for Atorvastatin Calcium Tablets USP, 20 mg film-coated oral tablets, manufactured by Accord Healthcare Inc. The label indicates a package containing 30 tablets. It includes storage instructions and dosage details, with prominent display of the NDC number 16729-045-10 and manufacturer information for Accord Healthcare and Intas Pharmaceuticals Limited.*
FDA Label Image

Atorvastatin Calcium Tablets – 40 mg 30 Bottle Label (Atorvastatin 40 mg 30 Bottle Label)

Atorvastatin Calcium Tablets – 40 mg 30 Bottle Label (Atorvastatin 40 mg 30 Bottle Label)
Label for Atorvastatin Calcium Tablets USP 40 mg, a film-coated oral tablet. The package contains 30 tablets and is labeled by Accord Healthcare Inc. It specifies storage instructions at controlled room temperature and includes manufacturer information both in the USA and India. The label includes dosage and usage notes referring to the prescribing information.*
FDA Label Image

Atorvastatin Calcium Tablets – 80 mg 30 Bottle Carton (Atorvastatin 80 mg 30 Bottle Label)

Atorvastatin Calcium Tablets – 80 mg 30 Bottle Carton (Atorvastatin 80 mg 30 Bottle Label)
Atorvastatin Calcium Tablets USP 80 mg film-coated tablet label. The label indicates the prescription drug is supplied in a package of 30 tablets by Accord Healthcare Inc., manufactured by Intas Pharmaceuticals Limited, India. Storage instructions specify 20°C to 25°C. Barcodes and NDC 16729-047-10 are shown.*
FDA Label Image

Figure (Atorvastatin Calcium Figure 1)

Figure (Atorvastatin Calcium Figure 1)
A Kaplan-Meier plot showing cumulative incidence (%) over 3.5 years comparing Atorvastatin and Placebo groups. The solid line represents Atorvastatin, while the dashed line represents Placebo. The cumulative incidence increases more slowly for Atorvastatin. A hazard ratio (HR) of 0.64 with confidence interval (0.50-0.83) and p-value 0.0005 is displayed, indicating statistical comparison of outcomes between the groups.*
FDA Label Image

Figure (Atorvastatin Calcium Figure 2)

Figure (Atorvastatin Calcium Figure 2)
A cumulative hazard plot comparing placebo and atorvastatin treatment groups over time. The y-axis shows cumulative hazard percentage from 0 to 15%, and the x-axis shows time to first primary endpoint up to 5 years. The graph includes a hazard ratio (HR=0.63) with confidence interval and p-value indicating statistical significance.*
FDA Label Image

Figure (Atorvastatin Calcium Figure 3)

Figure (Atorvastatin Calcium Figure 3)
A line graph comparing the percentage of subjects experiencing a major cardiovascular event over five years for Atorvastatin 10 mg (dashed line) and Atorvastatin 80 mg (solid line). The x-axis represents time in years to the first major cardiovascular endpoint, and the y-axis shows the percentage of subjects experiencing the event. The graph includes a hazard ratio (HR) of 0.78 with a confidence interval of 0.69 to 0.89 and a p-value of 0.0002, indicating reduced risk with the 80 mg dose compared to the 10 mg dose.*
FDA Label Image

Chemical Structure (Atorvastatin Calcium Structure)

Chemical Structure (Atorvastatin Calcium Structure)
Chemical structure diagram of atorvastatin calcium, illustrating its molecular composition including calcium ions and water molecules, consistent with the active ingredient in the film-coated oral tablets by Accord Healthcare Inc.*

* 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.