Aripiprazole Tablet, Orally Disintegrating
Product Images NDC 59651-514

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Aripiprazole (NDC 59651-514). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma Limited, 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

Fig1 (Aripiprazole Fig1)

A chart titled 'Effect of Other Drugs on Aripiprazole' showing fold changes and 90% confidence intervals for Aripiprazole pharmacokinetics (AUC and Cmax) when coadministered with various inhibitors and inducers. It compares CYP3A4 inhibitors, CYP2D6 inhibitors, CYP3A4 inducers, gastric acid blockers, and other drugs, illustrating changes relative to a reference without interacting drugs on a horizontal scale from 0.5 to 3.0.*

FDA Label Image

Package Label.principal Display Panel (10 mg (30 Tablets Bottle))

Label for Aripiprazole Orally Disintegrating Tablets, USP 10 mg, manufactured by Aurobindo Pharma Limited. The label states the product contains aripiprazole 10 mg per tablet, with a warning for phenylketonurics about phenylalanine content. It shows a package of 30 tablets, instructions for pharmacists, distributor information (Aurobindo Pharma USA, Inc.), and storage conditions.*

FDA Label Image

Package Label.principal Display Panel (10 mg Carton (3 x 10 Unit-dose))

Packaging label for Aripiprazole Orally Disintegrating Tablets, USP 10 mg by Aurobindo Pharma Limited. The label indicates a unit-dose package containing 30 tablets (3 x 10). It includes directions for use, storage instructions, and a note on phenylalanine content. The label also features barcodes, the NDC number 59651-514-03, and distributor information.*

FDA Label Image

Package Label.principal Display Panel (15 mg (30 Tablets Bottle))

Label for Aripiprazole Orally Disintegrating Tablets, USP 15 mg by Aurobindo Pharma Limited. The label indicates a prescription drug in tablet form, orally disintegrating, with a package quantity of 30 tablets. Distributed by Aurobindo Pharma USA, Inc., the label includes storage instructions and a warning for phenylketonurics regarding phenylalanine content.*

FDA Label Image

Package Label.principal Display Panel (15 mg Carton (3 x 10 Unit-dose))

Carton label for Aripiprazole Orally Disintegrating Tablets, USP, 15 mg, manufactured by Aurobindo Pharma Limited. The label shows the product name, strength, dosage form, NDC 59651-515-03, and package size of 30 unit-dose tablets (3 strips of 10 tablets each). Additional instructions and storage details are included.*

FDA Label Image

Fig2 (Aripiprazole Fig2)

A pharmacokinetic graph depicting the effect of various drugs on Aripiprazole, showing Dehydro-Aripiprazole fold change and 90% confidence intervals in AUC and Cmax values relative to a reference without interacting drugs. The chart includes inhibitors and inducers such as ketoconazole, quinidine, carbamazepine, famotidine, valproate, lithium, and lorazepam.*

FDA Label Image

Fig3 (Aripiprazole Fig3)

A forest plot chart titled "Effect of Aripiprazole on Other Drugs" showing fold change and 90% confidence intervals for various drugs affected by Aripiprazole. The x-axis represents change relative to reference (without interacting drug) ranging from 0.0 to 3.0. Drugs listed include dextromethorphan, warfarin, omeprazole, lamotrigine, valproate, lithium, lorazepam, venlafaxine, and escitalopram, with pharmacokinetic parameters such as AUC and Cmax presented for each.*

FDA Label Image

Fig4 (Aripiprazole Fig4)

A scatter plot titled 'Aripiprazole Fold Change and 90% CI' depicting pharmacokinetic changes across special populations. The x-axis shows 'Change Relative to Reference' from 0.5 to 3.0, and the y-axis lists subgroups for CYP2D6 metabolizer status, gender, age, hepatic impairment, and renal impairment. Data points with error bars illustrate fold changes in AUC and Cmax parameters for each subgroup compared to reference values.*

FDA Label Image

Fig5 (Aripiprazole Fig5)

A pharmacokinetic chart titled 'Dehydro-Aripiprazole Fold Change and 90% CI' comparing various factors such as CYP2D6 metabolizer status, gender, age, hepatic impairment, and renal impairment. It displays fold changes in AUC and Cmax values relative to a reference, with horizontal error bars representing 90% confidence intervals across these categories.*

FDA Label Image

Fig6 (Aripiprazole Fig6)

A Kaplan-Meier plot showing the proportion of subjects with relapse over time (days from randomization) comparing Aripiprazole and placebo groups. The x-axis displays days from randomization up to 182, and the y-axis shows the proportion with relapse from 0 to 1. Numbers of subjects at risk are shown below the x-axis for both groups at different time points.*

FDA Label Image

Fig (Aripiprazole Fig7)

A Kaplan-Meier survival curve showing the proportion of subjects with relapse over days from randomization for Aripiprazole and placebo groups. The x-axis represents days from randomization (0 to 182), and the y-axis shows the proportion with relapse (0 to 1.0). A table below the graph lists the number of subjects at risk at various time points for both groups.*

FDA Label Image

Figure 8 (Aripiprazole Fig8)

Kaplan-Meier survival curve showing the proportion of subjects with relapse over time (days from randomization) comparing Aripiprazole tablets orally disintegrating to placebo. The graph plots relapse proportion on the vertical axis and days on the horizontal axis, with subject numbers at risk displayed below for each treatment group.*

FDA Label Image

Figure 9 (Aripiprazole Fig9)

A line graph showing the change in YGTSS total tic score from baseline over 8 weeks of treatment. It compares three groups: Aripiprazole low dose, Aripiprazole high dose, and placebo. The y-axis indicates least-squares mean change in YGTSS total tic score, and the x-axis represents weeks of treatment.*

FDA Label Image

Str (Aripiprazole Str)

Chemical structure of aripiprazole, showing the molecular arrangement including two chlorine atoms on a benzene ring, a piperazine ring, a propoxy linker, and an indolinone moiety.*

* 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.