Abilify Maintena Kit
Product Images NDC 59148-245

Product Visual Gallery

This gallery contains 36 technical images submitted to the FDA as part of the official labeling for Abilify Maintena (NDC 59148-245). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Otsuka America Pharmaceutical, 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

Principal Display Panel (300 mg Syringe Carton)

Packaging label for Abilify Maintena 300 mg for extended release injectable suspension, containing a dual chamber syringe. The kit is labeled for deltoid or gluteal intramuscular injection only and includes instructions for administration by a healthcare professional. Manufactured by Otsuka America Pharmaceutical, Inc.*

FDA Label Image

Principal Display Panel (300 mg Syringe Label)

ABILIFY MAINTENA kit label showing 300 mg strength of aripiprazole for extended-release injectable suspension. The label specifies it is for single use only, intramuscular injection in the deltoid or gluteal muscle, and advises storage below 30°C (86°F) protected from light. It is manufactured by Otsuka America Pharmaceutical, Inc.*

FDA Label Image

Principal Display Panel (300 mg Kit Carton)

Packaging label for ABILIFY MAINTENA 300 mg per vial kit, an extended release injectable suspension of aripiprazole. Label indicates single use only for deltoid or gluteal intramuscular injection, with instructions to dispense an enclosed medication guide. Marketed and distributed by Otsuka America Pharmaceutical, Inc.*

FDA Label Image

Principal Display Panel (300 mg Vial Label)

Label for ABILIFY MAINTENA (aripiprazole) extended release injectable suspension, packaged as a kit. The label indicates a strength of 300 mg per vial, intended for single use only, sterile, for deltoid or gluteal intramuscular injection, and includes storage instructions. Manufactured by Otsuka Pharmaceutical Co., Ltd. and distributed by Otsuka America Pharmaceutical, Inc.*

FDA Label Image

Abilify 400mg Syringe Carton

Packaging label for ABILIFY MAINTENA 400 mg dual chamber syringe kit, containing aripiprazole for extended release injectable suspension. The label states it is for deltoid or gluteal intramuscular injection only and is for single use. The labeler is Otsuka America Pharmaceutical, Inc., and the product is labeled for prescription use only (Rx Only). The NDC number 59148-072-80 is visible.*

FDA Label Image

Principal Display Panel (400 mg Syringe Label)

Label for Abilify Maintena 400 mg (aripiprazole) extended release injectable suspension kit by Otsuka America Pharmaceutical, Inc. Label includes dosage indication, usage instructions for intramuscular injection, storage conditions to keep below 30°C (86°F) and protect from light, manufacturer information, and barcodes.*

FDA Label Image

Principal Display Panel (400 mg Kit Carton)

Packaging label for Abilify Maintena 400 mg kit, an extended release injectable suspension of aripiprazole. The label indicates the dosage strength as 400 mg per vial and specifies single use only for deltoid or gluteal intramuscular injection. The labeler is Otsuka America Pharmaceutical, Inc., with distribution details and instructions to dispense an enclosed Medication Guide.*

FDA Label Image

Principal Display Panel (400 mg Vial Label)

Label for ABILIFY MAINTENA 400 mg per vial (aripiprazole) extended release injectable suspension kit. The label indicates the product is single-use, sterile, for intramuscular injection into the deltoid or gluteal muscle, and includes storage instructions. Manufactured and distributed by Otsuka America Pharmaceutical, Inc., marketed by Lundbeck.*

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Principal Display Panel (5 mL Vial Label)

A 5 mL vial label for Sterile Water for Injection, USP. The label states it is for single use only and instructs to discard unused portion. Storage conditions are specified as 25 °C with allowed excursions between 15 °C and 30 °C. The label includes a barcode, lot number, and indicates Rx only. Distributed and manufactured by a pharmaceutical company as noted.*

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Chemical Structure (Abilify Chem Structure)

Chemical structure of aripiprazole, the active ingredient in ABILIFY MAINTENA. The diagram shows the molecular arrangement including chlorine-substituted aromatic rings and a quinolinone moiety hydrate form.*

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Figure 1 (Abilify Figure 01)

An instructional diagram showing a hand holding a syringe with a labeled plunger rod. The image includes a note explaining that when the plunger rod reaches a complete stop, the middle stopper aligns with the indicator line on the syringe.*

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Figure 2 (Abilify Figure 02)

An instructional diagram showing a hand holding a syringe labeled "Uniform Milky White" with a 20-second clock icon. It includes arrows indicating a shaking motion and a note to use the syringe within 30 minutes after reconstitution.*

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Figure 3 (Abilify Figure 03)

An instructional diagram showing how to remove caps from a medication vial by twisting and pulling off. It labels the 'Over-cap' and 'Tip-cap' on the vial, with arrows indicating the direction to twist and pull for removal.*

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Figure 4 (Abilify Figure 04)

An instructional diagram showing recommended injection sites and needle sizes for ABILIFY MAINTENA based on body type. For non-obese individuals, deltoid injections use 1 inch (23G) needles and gluteus injections use 1.5 inch (22G) needles. For obese individuals, deltoid injections use 1.5 inch (22G) needles and gluteus injections use 2 inch (21G) needles. Illustrations depict needle orientation and injection sites.*

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Figure 5 (Abilify Figure 05)

An instructional diagram showing how to attach a needle to a syringe. It illustrates twisting the needle cap to snug it onto the syringe with arrows indicating the direction of movement. Labeled parts include the needle cap.*

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Figure 6 (Abilify Figure 06)

An instructional illustration showing the removal of a needle cap from a syringe. The image depicts a syringe with the needle cap being pulled upward, indicated by an arrow and labeled 'Needle cap' and 'Pull.' The illustration is likely part of administration instructions for ABILIFY MAINTENA injection kit.*

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Figure 7 (Abilify Figure 07)

An instructional illustration demonstrating how to expel air from a syringe containing a suspension until the needle base is filled, with a note advising to check the plunger rod rotation if resistance or difficulty is encountered.*

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Figure 8 (Abilify Figure 08)

Illustration showing two steps for syringe handling: removing a cover from the needle and discarding the syringe into a biohazard sharps container. The image emphasizes safe disposal of medical sharps to prevent contamination or injury.*

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Figure 9 (Abilify Figure 09)

An instructional illustration showing the preparation of a syringe by withdrawing medication from a vial. The image depicts a hand holding a vial upside down with a needle inserted, while the other hand pulls back the syringe plunger to draw liquid into the syringe barrel.*

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Figure 10 (Abilify Figure 10)

An instructional line drawing showing a hand holding a syringe drawing fluid from a vial. The syringe plunger is being pulled upwards, and the vial is held steady by another hand. This image likely demonstrates the process of withdrawing medication from a vial, associated with the ABILIFY MAINTENA kit.*

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Figure 11 (Abilify Figure 11)

An illustration showing a hand holding a syringe with the needle pointing downward. The image demonstrates bending or breaking the needle at a marked point, indicated by an arrow pointing to the right and downward, with the syringe positioned above a flat surface.*

FDA Label Image

Figure 12 (Abilify Figure 12)

An instructional diagram showing a hand holding a small vial, with a double-headed arrow indicating a shaking or mixing motion. The vial likely corresponds to ABILIFY MAINTENA, a kit for injection containing aripiprazole.*

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Figure 13 (Abilify Figure 13)

An instructional illustration showing a close-up of hands manipulating a small object, possibly demonstrating a step in the use or preparation of a drug product component, with an arrow indicating a specific motion or direction to be followed.*

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Figure 14 (Abilify Figure 14)

An instructional line drawing showing hands assembling a syringe with a vial adapter for injectable medication. The image focuses on the process of inserting the syringe into the vial adapter, as used in preparing aripiprazole injectable medication in the ABILIFY MAINTENA kit.*

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Figure 15 (Abilify Figure 15)

An instructional illustration showing hands assembling or preparing a syringe by inserting or attaching it to a circular component, likely part of the ABILIFY MAINTENA medication kit for injection preparation.*

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Figure 16 (Abilify Figure 16)

An instructional illustration depicting a hand holding a vial and attaching a syringe to it, likely showing preparation of a medication dose. The image includes arrows indicating the steps to connect and secure the syringe to the vial.*

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Figure 17 (Abilify Figure 17)

An instructional illustration showing a hand holding a vial and a syringe. The syringe plunger is being pulled down to withdraw liquid from the vial, indicated by an arrow pointing downward on the plunger. The image demonstrates the proper technique for drawing medication into a syringe, relevant to the ABILIFY MAINTENA kit.*

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Figure 18 (Abilify Figure 18)

An instructional illustration showing hands preparing a syringe for injection by twisting or securing a component, likely related to the assembly or use of the ABILIFY MAINTENA kit for administration.*

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Figure 19 (Abilify Figure 19)

A pharmacokinetic chart illustrating the fold change and 90% confidence interval of aripiprazole exposure (AUC and Cmax) when combined with various interacting drugs, including CYP3A4 inhibitors (ketoconazole), CYP2D6 inhibitors (quinidine), CYP3A4 inducers (carbamazepine), gastric acid blockers (famotidine), and others (valproate, lithium, lorazepam). The x-axis represents change relative to reference without interacting drugs.*

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Figure 20 (Abilify Figure 20)

A pharmacokinetic chart showing the effect of various drugs on Abilify (aripiprazole) metabolism. The x-axis represents the fold change in dehydro-aripiprazole concentration relative to a reference without drug interaction; the y-axis lists different interacting drugs categorized as CYP3A4 inhibitors, CYP2D6 inhibitors, CYP3A4 inducers, gastric acid blockers, and others. Error bars indicate 90% confidence intervals for AUC and Cmax changes.*

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Figure 21 (Abilify Figure 21)

A graph illustrating the effect of Abilify (aripiprazole) on the pharmacokinetics of various other drugs. The x-axis shows fold change relative to a reference without interacting drug, while the y-axis lists several drugs, including dextromethorphan, warfarin, omeprazole, lamotrigine, valproate, lithium, lorazepam, venlafaxine, and escitalopram. Data points with 90% confidence intervals show changes in parameters such as AUC and Cmax.*

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Figure 22 (Abilify Figure 22)

A forest plot displaying aripiprazole fold change and 90% confidence intervals for various special populations. It compares pharmacokinetic parameters (AUC and Cmax) across groups such as CYP2D6 metabolizer status, gender, age, hepatic impairment levels, and severe renal impairment relative to a reference value.*

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Figure 23 (Abilify Figure 23)

A pharmacokinetic chart depicting dehydro-aripiprazole fold change with 90% confidence intervals across various factors including CYP2D6 metabolism profile, gender, age, levels of hepatic impairment, and severe renal impairment. The x-axis shows change relative to reference values, while the y-axis lists the compared groups and pharmacokinetic parameters AUC and Cmax.*

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Figure 24 (Abilify Figure 24)

A line graph titled "Change in PANSS Total Score from Baseline" showing least-square mean changes over 12 weeks of treatment. It compares ABILIFY MAINTENA and placebo groups, with ABILIFY MAINTENA showing a greater decrease in PANSS total score over time. The x-axis represents weeks of treatment (0 to 12), and the y-axis shows the change in PANSS total score from 0 to -30. Patient numbers for each group per time point are listed below the graph.*

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Figure 25 (Abilify Figure 25)

A Kaplan-Meier curve showing time to relapse over 364 days comparing ABILIFY MAINTENA and placebo. The y-axis represents the proportion of patients with relapse (0% to 80%), and the x-axis shows days from randomization. ABILIFY MAINTENA is depicted with a dashed line, placebo with a solid line, alongside numbers of subjects at risk for each group at intervals below the x-axis.*

FDA Label Image

Figure 26 (Abilify Figure 26)

A Kaplan-Meier curve showing time to recurrence over 364 days comparing ABILIFY MAINTENA (n=132) and placebo (n=133). The y-axis represents the proportion of subjects with recurrence, ranging from 0% to 80%. The x-axis shows time in days from randomization, with numbers at risk listed below for both groups. ABILIFY MAINTENA is depicted with a dashed line, and placebo with a solid line, illustrating differences in recurrence rates over time.*

* 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.