Alogliptin Tablet, Film Coated
Product Images NDC 71610-300

7 FDA label images from Aphena Pharma Solutions - Tennessee, Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Alogliptin (NDC 71610-300). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aphena Pharma Solutions - Tennessee, 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

Bottle Label 25 mg (71610 0300 09)

Bottle Label 25 mg (71610 0300 09)
Label for Alogliptin 25 mg film-coated tablets, containing 9000 tablets. The label provides storage instructions to keep at 20-25 degrees Celsius and in a USP-controlled room temperature environment. The product is manufactured by Takeda Pharmaceuticals America, Inc., Deerfield, IL, and repackaged by Aphena Pharma Solutions - Tennessee, LLC in Cookeville, TN. The label includes the National Drug Code (NDC) 71610-0300 and indicates the product is for prescription use only (Rx Only).*
FDA Label Image

Aphena Pharma Solutions (TN)

FDA Label Image

Chemical Structure (Alogliptin 01)

Chemical Structure (Alogliptin 01)
Chemical structure of alogliptin, showing its molecular composition including nitrogen, carbon, oxygen atoms, and a benzoic acid moiety attached.*
FDA Label Image

Figure 1 (Alogliptin 02)

Figure 1 (Alogliptin 02)
A chart displaying the pharmacokinetic (PK) interaction data of Alogliptin with various coadministered drugs. It shows ratios and 90% confidence intervals for AUC and Cmax comparing Alogliptin plus the other drug versus the other drug alone. The chart includes multiple substrates and recommendations indicating no dose adjustment is needed across all drug interactions tested.*
FDA Label Image

Figure 2 (Alogliptin 03)

Figure 2 (Alogliptin 03)
A clinical pharmacokinetic chart displaying the ratio and 90% confidence intervals of Alogliptin exposure (AUC and Cmax) when administered alone versus coadministrated with various drugs, including metformin, cimetidine, gemfibrozil, pioglitazone, fluconazole, ketoconazole, atorvastatin, cyclosporine, and digoxin. The chart shows data points indicating no significant dose adjustments are recommended for these drug combinations.*
FDA Label Image

Figure 3 (Alogliptin 04)

Figure 3 (Alogliptin 04)
A bar graph showing least squares mean change in A1C (%) comparing placebo, Alogliptin 25 mg, Pioglitazone (15 mg, 30 mg, 45 mg), and combinations of Alogliptin 25 mg with Pioglitazone (15 mg, 30 mg, 45 mg). The baseline mean A1C is 8.5 to 8.6. Bars depict reductions in A1C, with combined doses showing greater reductions than individual doses.*
FDA Label Image

Figure 4 (Alogliptin 05)

Figure 4 (Alogliptin 05)
A Kaplan-Meier cumulative event probability curve comparing Nesina (alogliptin) and placebo groups over 30 months from randomization. The chart plots event probability on the y-axis and months on the x-axis, showing event progression for both groups. Numbers at risk for each group are listed below the x-axis at various time points.*

* 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.