Aripiprazole Solution
Product Images NDC 65162-893

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Aripiprazole (NDC 65162-893). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Amneal Pharmaceuticals 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

8f42eff5-figure-01 (Aripiprazole Oral Solution 1)

Chemical structure diagram of aripiprazole, showing its molecular arrangement including a dichlorophenyl group, piperazine ring, and quinolinone moiety, consistent with the active ingredient in Aripiprazole oral solution.*

FDA Label Image

Figure 9 (Aripiprazole Oral Solution 10)

Line graph showing the change in YGTSS total tic score from baseline over 8 weeks of treatment. The x-axis represents weeks of treatment (0 to 8), and the y-axis shows the least-squares mean change in YGTSS total tic score, ranging from 0 to -20. Three lines compare ARIP-LOW, ARIP-HIGH, and placebo groups, illustrating greater reductions in tic scores with ARIP-HIGH and ARIP-LOW versus placebo over time.*

FDA Label Image

Label (Aripiprazole Oral Solution 11)

Label for Aripiprazole Oral Solution 1 mg/mL by Amneal Pharmaceuticals LLC. It includes tamper-evident seal instructions, dosage information reference to package insert, storage conditions, 150 mL net contents, and pharmacist dispensing guidance. The label features the NDC 65162-893 and Amneal logo with lot and expiration placeholders.*

FDA Label Image

Carton (Aripiprazole Oral Solution 12)

Packaging label for Aripiprazole Oral Solution 1 mg/mL by Amneal Pharmaceuticals LLC. It displays the product name, strength, dosage form, a tamper-evident seal warning, storage instructions, net contents of 150 mL, a barcode, and directions for pharmacists regarding the medication guide. The label includes the NDC number 65162-893 and emphasizes Rx only use.*

FDA Label Image

Figure 1 (Aripiprazole Oral Solution 2)

A pharmacokinetic chart titled 'Effect of Other Drugs on Aripiprazole' showing the fold change and 90% confidence intervals for aripiprazole's AUC and Cmax when coadministered with various drugs. The x-axis represents change relative to reference (without interacting drug) ranging from 0 to 3. Drugs include CYP3A4 inhibitors (ketoconazole), CYP2D6 inhibitor (quinidine), CYP3A4 inducer (carbamazepine), gastric acid blockers (famotidine), and others (valproate, lithium, lorazepam). The chart presents comparative impact on aripiprazole's pharmacokinetics.*

FDA Label Image

Figure 2 (Aripiprazole Oral Solution 3)

A forest plot chart titled "Effect of Other Drugs on Aripiprazole," displaying the fold change and 90% confidence intervals for dehydro-aripiprazole levels relative to reference without interacting drugs. It compares pharmacokinetic parameters AUC and Cmax for aripiprazole when co-administered with CYP3A4 inhibitor ketoconazole, CYP2D6 inhibitor quinidine, CYP3A4 inducer carbamazepine, gastric acid blocker famotidine, and other drugs valproate, lithium, and lorazepam.*

FDA Label Image

Figure 3 (Aripiprazole Oral Solution 4)

A forest plot chart titled 'Effect of Aripiprazole on Other Drugs' showing fold changes with 90% confidence intervals for pharmacokinetic parameters (AUC and Cmax) of various drugs, including dextromethorphan, warfarin (S- and R-), omeprazole, lamotrigine, valproate, lithium, lorazepam, venlafaxine, 0-desmethylvenlafaxine, and escitalopram. The x-axis represents change relative to reference (without interacting drug) ranging from 0 to 3.*

FDA Label Image

Figure 4 (Aripiprazole Oral Solution 5)

A pharmacokinetic chart titled 'Aripiprazole Fold Change and 90% CI' illustrating fold changes with 90% confidence intervals in parameters AUC and Cmax for Aripiprazole oral solution 1 mg/mL across various special populations, including CYP2D6 metabolizer status, gender, age groups, hepatic impairment levels, and severe renal impairment. The x-axis represents change relative to reference, ranging from 0.5 to 3.0.*

FDA Label Image

Figure 5 (Aripiprazole Oral Solution 6)

A pharmacokinetic chart titled 'Dehydro-Aripiprazole Fold Change and 90% CI' showing fold changes in AUC and Cmax for different conditions, including CYP2D6 metabolizer status, gender, age groups, hepatic impairment levels, and severe renal impairment. The x-axis represents change relative to reference, and fold changes vary around the reference line for each category.*

FDA Label Image

Figure 6 (Aripiprazole Oral Solution 7)

A line graph showing the proportion of subjects with relapse over time in days from randomization, comparing Aripiprazole and placebo groups. The graph includes the number of subjects at risk for each group at various time points up to 182 days. The placebo group shows a higher relapse proportion over time compared to the Aripiprazole group.*

FDA Label Image

Figure 7 (Aripiprazole Oral Solution 8)

A Kaplan-Meier survival curve chart depicting the proportion of subjects experiencing relapse over 182 days from randomization. The solid line represents subjects taking Aripiprazole oral solution 1 mg/mL, and the dashed line represents placebo subjects. The chart includes a risk table showing the number of subjects at risk in each group at various time points.*

FDA Label Image

Figure 8 (Aripiprazole Oral Solution 9)

A line chart comparing the proportion of subjects with relapse over 364 days from randomization between Aripiprazole and placebo groups. The x-axis represents days from randomization, while the y-axis shows the proportion with relapse. Two lines represent Aripiprazole (solid) and placebo (dashed). A table below the x-axis displays the number of subjects at risk at various time points for each group.*

* 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.