Aripiprazole
Product Images NDC 68071-3471

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Aripiprazole (NDC 68071-3471). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Nucare Pharmaceuticals,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

Pdp (68071 3471 3)

This is a label for Aripiprazole 5 mg tablets by NuCare Pharmaceuticals, Inc. The package contains 30 tablets. The label displays dosage strength, quantity, manufacturer information, NDC number 68071-3471-3, barcodes, and storage instructions to keep at controlled temperatures between 68-77°F. It includes warnings to keep out of reach of children and notes the product is Rx only.*

FDA Label Image

Figure1 (Figure1)

A chart titled 'Effect of Other Drugs on Aripiprazole' illustrating fold change and 90% confidence intervals for various interacting drugs. The x-axis shows change relative to reference without interacting drug, ranging from 0.0 to 3.0. Data points represent changes in AUC and Cmax with inhibitors, inducers, gastric acid blockers, and other drugs.*

FDA Label Image

Figure2 (Figure2)

A chart titled 'Effect of Other Drugs on Aripiprazole' showing dehydro-aripiprazole fold change and 90% confidence intervals. The x-axis represents change relative to a reference without interacting drugs, ranging from 0 to 3. The y-axis lists drug categories: CYP3A4 inhibitor (ketoconazole), CYP2D6 inhibitor (quinidine), CYP3A4 inducer (carbamazepine), gastric acid blockers (famotidine), and others (valproate, lithium, lorazepam), with pharmacokinetic parameters AUC and Cmax indicated. Data points with error bars illustrate the relative fold changes for each drug interaction.*

FDA Label Image

Figure3 (Figure3)

A chart depicting the effect of aripiprazole on the pharmacokinetics of various other drugs. The x-axis shows the fold change relative to a reference without interacting drug, ranging from 0.5 to 3.0. The y-axis lists drugs or enzymes such as CYP2D6, dextrorphan, CYP2C9, 2C19, warfarin (S- and R-), omeprazole, UGT1A4, lamotrigine, valproate, lithium, lorazepam, venlafaxine, and O-desmethylvenlafaxine, with pharmacokinetic measures like AUC, Cmax, DWMDRP, and INR. Data points with 90% confidence intervals indicate changes in these parameters.*

FDA Label Image

Figure4 (Figure4)

A chart titled "Aripiprazole Fold Change and 90% CI" showing pharmacokinetic comparisons (AUC and Cmax) for various special populations relative to a reference group. Factors compared include CYP2D6 metabolizer status, gender, age groups, and degrees of hepatic and renal impairment, with fold change values and confidence intervals plotted horizontally.*

FDA Label Image

Figure5 (Figure5)

A pharmacokinetic chart titled 'Dehydro-Aripiprazole Fold Change and 90% CI' showing changes in AUC and Cmax relative to reference for various factors including CYP2D6 metabolizer status, gender, age groups, hepatic impairment severity, and severe renal impairment. The horizontal axis represents fold change relative to reference with error bars indicating 90% confidence intervals.*

FDA Label Image

Structure (Structure)

Chemical structure of the active ingredient Aripiprazole, showing its molecular configuration including aromatic rings, nitrogen atoms, and chlorine substitutions.*

FDA Label Image

Figure 6 (Figure 6)

A line graph showing the proportion of subjects with relapse over days from randomization comparing Aripiprazole versus placebo. The x-axis represents days from randomization (0 to 182), and the y-axis shows the proportion with relapse (0 to 1.0). The graph includes subject counts at risk for each group at different time points.*

FDA Label Image

Figure 7 (Figure 7)

A Kaplan-Meier survival curve chart showing the proportion of subjects with relapse over days from randomization. The chart compares Aripiprazole treatment (solid line) with placebo (dashed line), including numbers of subjects at risk listed below the x-axis. The y-axis represents proportion with relapse, and the x-axis represents days from randomization up to 182 days.*

FDA Label Image

Figure 8 (Figure 8)

A Kaplan-Meier survival curve chart showing the proportion with relapse over days from randomization for Aripiprazole and placebo groups. The x-axis represents days from randomization up to 364 days, and the y-axis shows the proportion with relapse from 0 to 1. The chart includes the number of subjects at risk at different time points for both 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.