Aripiprazole Solution
Product Images NDC 60505-0404

12 FDA label images from Apotex Corp. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Aripiprazole (NDC 60505-0404). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Apotex Corp., 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-arip-os-image03.jpg (Bottle Arip Os Image03)

Bottle-arip-os-image03.jpg (Bottle Arip Os Image03)
Label for Aripiprazole Oral Solution 1 mg/mL, a 150 mL oral liquid product by Apotex Corp. The label includes dosage strength, NDC 60505-0404-5, storage instructions at controlled room temperature (20°-25°C), and pharmacist instructions to dispense the medication guide. Manufacturer locations in Toronto, Ontario, Canada, and Weston, Florida, USA, are also noted.*
FDA Label Image

Carton-arip-os-image04.jpg (Carton Arip Os Image04)

Carton-arip-os-image04.jpg (Carton Arip Os Image04)
Packaging label for Aripiprazole Oral Solution 1 mg/mL, a 150 mL oral solution prescription drug by Apotex Corp. The label includes dosage strength, directions to keep out of reach of children, storage instructions at controlled room temperature, and manufacturer information for Apotex Inc. and Apotex Corp. It features barcodes and a note about dispensing the enclosed Medication Guide.*
FDA Label Image

Fig-1 (Fig 1)

Fig-1 (Fig 1)
A pharmacokinetic chart depicting the fold change and 90% confidence interval of aripiprazole's AUC and Cmax when co-administered with various drugs. The x-axis shows change relative to reference (no interacting drug), and the y-axis lists CYP3A4 inhibitors, CYP2D6 inhibitors, CYP3A4 inducers, gastric acid blockers, and other drugs affecting aripiprazole levels.*
FDA Label Image

Fig-2 (Fig 2)

Fig-2 (Fig 2)
A plot chart showing the effect of various other drugs on the pharmacokinetics (PK) of aripiprazole and its metabolite dehydro-aripiprazole. It details fold changes and 90% confidence intervals for AUC and Cmax values relative to a reference without interacting drugs, including CYP3A4 inhibitors, CYP2D6 inhibitors, CYP3A4 inducers, gastric acid blockers, and other drugs.*
FDA Label Image

Fig-3 (Fig 3)

Fig-3 (Fig 3)
A chart showing the effect of aripiprazole on other drugs, depicting fold change and 90% confidence intervals. The x-axis represents change relative to a reference without interacting drug, ranging from 0.5 to 3.0. The y-axis lists various drugs and enzymes like CYP2D6, CYP2C9, 2C19, UGT1A4, and others along with their pharmacokinetic parameters such as AUC and Cmax.*
FDA Label Image

Fig-4 (Fig 4)

Fig-4 (Fig 4)
A forest plot chart titled 'Aripiprazole Fold Change and 90% CI' showing pharmacokinetic comparisons (AUC and Cmax) of aripiprazole across special populations. Comparisons include CYP2D6 metabolizer status, gender, age groups, hepatic impairment levels, and severe renal impairment. The x-axis represents change relative to reference from 0.5 to 3.0 fold, with data points depicted as squares with confidence intervals.*
FDA Label Image

Fig-5 (Fig 5)

Fig-5 (Fig 5)
A forest plot showing the fold change in pharmacokinetics (AUC and Cmax) of dehydro-aripiprazole across different populations, including CYP2D6 metabolizer status, gender, age groups, hepatic impairment severity, and severe renal impairment, with 90% confidence intervals plotted relative to a reference value of 1.0.*
FDA Label Image

Fig-6 (Fig 6)

Fig-6 (Fig 6)
A Kaplan-Meier survival curve showing the proportion of subjects with relapse over time in days from randomization comparing aripiprazole and placebo groups. The x-axis represents days from randomization up to 182 days, and the y-axis represents the proportion with relapse from 0.0 to 1.0. The chart includes the number of subjects at risk at various time points for both aripiprazole and placebo groups.*
FDA Label Image

Fig-7 (Fig 7)

Fig-7 (Fig 7)
A Kaplan-Meier type plot showing the proportion of subjects with relapse over time in days from randomization comparing aripiprazole and placebo groups. The graph includes lines representing relapse proportions for each group and a table of the number of subjects at risk at various time points.*
FDA Label Image

Fig-8 (Fig 8)

Fig-8 (Fig 8)
A Kaplan-Meier survival curve comparing the proportion of subjects with relapse over 364 days following randomization for aripiprazole and placebo groups. The y-axis shows proportion with relapse, and the x-axis shows days from randomization. Tables below the x-axis indicate the number of subjects at risk over time for each group.*
FDA Label Image

Fig-9 (Fig 9)

Fig-9 (Fig 9)
A line graph depicting the change in YGTSS Total TIC Score from baseline over 8 weeks of treatment. The graph compares three groups: ARIP-LOW, ARIP-HIGH, and PLACEBO, showing a greater decrease in scores for the ARIP-HIGH and ARIP-LOW groups compared to the placebo group over time.*
FDA Label Image

Arip-structure (Arip Structure)

Arip-structure (Arip Structure)
Chemical structure of aripiprazole depicted as a 2D molecular diagram showing rings, functional groups, and atoms including chlorine and oxygen consistent with the generic drug aripiprazole.*

* 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.