Aristada Injection, Suspension, Extended Release
Product Images NDC 65757-403

Product Visual Gallery

This gallery contains 19 technical images submitted to the FDA as part of the official labeling for Aristada (NDC 65757-403). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Alkermes, 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

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An instructional line drawing of a syringe labeled 'A', showing the needle end and the plunger, likely used for administering aripiprazole lauroxil injection suspension extended release. The illustration focuses on the syringe without specific text or measurements.*

FDA Label Image

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An instructional illustration showing partial views of a handheld device or applicator in three different positions labeled B, C, and D. The image appears as a sequence or comparison of device manipulations, relevant to the administration or processing of aripiprazole lauroxil injection suspension but does not display text or specific product details.*

FDA Label Image

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Illustration showing how to prepare an injection suspension by tapping the vial 10 times and then shaking vigorously for 30 seconds, with hand and stopwatch visuals for guidance.*

FDA Label Image

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Instructional illustration showing a person removing or cutting a plastic or foil seal from a medical vial or container using a pair of scissors. The hands are positioned to hold the container steady while cutting the seal, likely as a preparation step for using the medication.*

FDA Label Image

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An instructional line drawing showing hands preparing a syringe. One hand holds the syringe barrel while the other adjusts the plunger, with a needle cap attached to the syringe tip, demonstrating preparation for injection.*

FDA Label Image

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An instructional line drawing showing how to remove a cap from a syringe. The illustration depicts two hands holding a syringe, with one hand pulling the cap upwards to detach it from the needle-end of the syringe.*

FDA Label Image

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An illustration showing a hand activating or pressing down on the plunger of a syringe, indicated by a directional arrow. The image likely demonstrates part of the administration or preparation process for an injection.*

FDA Label Image

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An instructional illustration depicting a hand holding and using a mixing or reconstitution device, possibly for preparing an injection suspension. The device shown includes a vial and a connected applicator or syringe, indicating a step in the drug preparation process.*

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Chemical structure diagram showing the molecular composition of aripiprazole lauroxil, the active ingredient in the injection suspension extended-release formulation by Alkermes, Inc.*

FDA Label Image

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A scatter plot titled 'Aripiprazole Fold Change and 90% CI' showing the effects of various drugs on aripiprazole pharmacokinetics. It compares fold change in AUC (area under the curve) and Cmax (maximum concentration) relative to a reference without interacting drug, including CYP3A4 and CYP2D6 inhibitors and inducers, gastric acid blockers, and other drugs like valproate, lithium, and lorazepam. Error bars represent 90% confidence intervals.*

FDA Label Image

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A pharmacokinetic chart showing the fold change in Dehydro-Aripiprazole levels with 90% confidence intervals when co-administered with various drugs. The chart compares the change relative to a reference without interacting drugs for CYP3A4 inhibitors (ketoconazole), CYP2D6 inhibitors (quinidine), CYP3A4 inducers (carbamazepine), gastric acid blockers (famotidine), and other drugs including valproate, lithium, and lorazepam.*

FDA Label Image

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A forest plot chart showing fold change and 90% confidence intervals for various drugs and metabolic enzymes relative to a reference drug. The chart includes drugs like dextromethorphan, warfarin, omeprazole, lamotrigine, valproate, lithium, lorazepam, venlafaxine, and escitalopram, with pharmacokinetic parameters such as AUC and Cmax plotted on the x-axis as change relative to the reference drug.*

FDA Label Image

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A forest plot chart illustrating aripiprazole fold change and 90% confidence intervals (CI) in pharmacokinetic parameters AUC and Cmax. The x-axis shows the relative change to reference (0.5 to 3.0). Variables compared include CYP2D6 metabolism status, gender, age groups, hepatic impairment (mild, moderate, severe), and severe renal impairment.*

FDA Label Image

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A forest plot depicting the fold change and 90% confidence intervals of dehydro-aripiprazole pharmacokinetic parameters AUC and Cmax, stratified by CYP2D6 metabolizer status, gender, age groups, hepatic impairment severity, and severe renal impairment. The plot shows comparisons like poor vs. extensive metabolizers and mild to severe hepatic impairment vs. normal function.*

FDA Label Image

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A line graph depicting the change from baseline in PANSS total score over multiple visit days for three treatment groups: placebo (PBO), aripiprazole lauroxil (AL) 441 mg monthly, and AL 882 mg monthly. The x-axis shows visit days, and the y-axis shows change from baseline in PANSS total score, with scores decreasing over time for AL groups compared to placebo.*

FDA Label Image

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Packaging label for Aristada 441 mg aripiprazole lauroxil extended-release injectable suspension by Alkermes, Inc. The label specifies a 441 mg/1.6 mL dosage for intramuscular injection in the deltoid or gluteal muscle. It includes instructions indicating single-dose injection by a healthcare professional and storage conditions. The label also instructs users to read complete instructions prior to use.*

FDA Label Image

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Aristada 662 mg extended-release injectable suspension carton label for aripiprazole lauroxil by Alkermes, Inc. The label indicates the product is for gluteal intramuscular injection only and that the entire syringe content must be administered by a healthcare professional. Storage instructions and warnings to keep out of reach of children are included.*

FDA Label Image

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Aristada 882 mg extended-release injectable suspension carton label for aripiprazole lauroxil by Alkermes, Inc. The label indicates a single-dose syringe for gluteal intramuscular injection, 882 mg/3.2 mL, administered monthly or every 6 weeks. Storage instructions and warnings to keep out of reach of children are included. The label also notes that administration needles are inside and instructs to remove the flap.*

FDA Label Image

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Packaging label for Aristada 1064 mg aripiprazole lauroxil extended-release injectable suspension by Alkermes, Inc. The label indicates it is for a 1064 mg/3.9 mL single-dose syringe for gluteal intramuscular injection only. It includes administration instructions emphasizing professional healthcare administration and dosage frequency every two months. Storage temperature and safety warnings are also visible.*

* 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.