Rosuvastatin Tablet, Film Coated
Product Images NDC 16729-286

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 Rosuvastatin (NDC 16729-286). 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

Strucural Formula (Rosuvastatin Calcium Structure)

Strucural Formula (Rosuvastatin Calcium Structure)
Chemical structure of Rosuvastatin calcium, the active ingredient in Rosuvastatin tablets. The diagram shows molecular components including a fluorophenyl group, sulfonamide, hydroxyl groups, and calcium ions associated with the molecule.*
FDA Label Image

Figure-1 (Rosuvastatin Figure 1)

Figure-1 (Rosuvastatin Figure 1)
A Kaplan-Meier cumulative incidence curve comparing Rosuvastatin (solid line) to placebo (dotted line) over approximately 5 years. The graph shows lower cumulative incidence percentages over time for Rosuvastatin versus placebo, with hazard ratio and statistical significance indicated. A table below the graph shows the number of patients at risk for each group at various time points.*
FDA Label Image

Figure-2 (Rosuvastatin Figure 2)

Figure-2 (Rosuvastatin Figure 2)
A forest plot table showing hazard ratios with 95% confidence intervals and p-values comparing events between Rosuvastatin 20 mg and placebo 20 mg groups. It includes endpoints such as primary endpoint (MCE), cardiovascular death, nonfatal stroke, nonfatal MI, hospitalized unstable angina, and arterial revascularization, with corresponding event numbers, rates, and statistical significance.*
FDA Label Image

Figure-3 (Rosuvastatin Figure 3)

Figure-3 (Rosuvastatin Figure 3)
A box plot chart comparing percent change from baseline in LDL-C levels across different doses of four statin drugs: Rosuvastatin (10, 20, 40 mg), Atorvastatin (10, 20, 40, 80 mg), Simvastatin (10, 20, 40, 80 mg), and Pravastatin (10, 20, 40 mg). The y-axis represents percent change, illustrating LDL-C reduction efficacy for each dosage.*
FDA Label Image

5 mg Bottle Label 30 Tablets (Rosuvastatin 5mg)

5 mg Bottle Label 30 Tablets (Rosuvastatin 5mg)
Packaging label for Rosuvastatin Tablets, USP 5 mg film-coated tablets by Accord Healthcare Inc. The label displays dosage strength (5 mg), quantity (30 tablets), manufacturer information, storage instructions, and warnings. Both National Drug Code (NDC 16729-284-10) and barcodes are visible on the label.*
FDA Label Image

10 mg Bottle Label 30 Tablets (Rosuvastatin 10mg)

10 mg Bottle Label 30 Tablets (Rosuvastatin 10mg)
Rosuvastatin Tablets, USP 10 mg film-coated tablets in a label for a 30-tablet package. The label includes dosage and storage warnings, manufacturer details (Accord Healthcare Inc. and Intas Pharmaceuticals Limited), and NDC 16729-285-10. It features barcodes and a designated area for lot and expiration date overcoding.*
FDA Label Image

20 mg Bottle Label 30 Tablets (Rosuvastatin 20mg)

20 mg Bottle Label 30 Tablets (Rosuvastatin 20mg)
Label for Rosuvastatin Tablets USP 20 mg manufactured by Intas Pharmaceuticals for Accord Healthcare Inc. The label includes dosage form as film-coated tablets, a package size of 30 tablets, and storage instructions. The NDC is 16729-286-10. Barcode and lot/expiration area are visible.*
FDA Label Image

40 mg Bottle Label 30 Tablets (Rosuvastatin 40mg)

40 mg Bottle Label 30 Tablets (Rosuvastatin 40mg)
Label for Rosuvastatin Tablets, USP 40 mg, film-coated oral tablets. The label includes the NDC number 16729-287-10, indicates a quantity of 30 tablets, and states the product is Rx only. It is manufactured for Accord Healthcare Inc., Durham, NC, and by Intas Pharmaceuticals Limited, India. Storage instructions and warnings are also present.*

* 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.