Opipza Film, Soluble
Product Images NDC 15370-403

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Opipza (NDC 15370-403). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Carwin Pharmaceutical Associates, 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.

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Chemical Structure (Opipza 01)

Chemical structure of aripiprazole, the active ingredient in OPIPZA. The structure shows the molecular framework including chloro-substituted aromatic rings, a piperazine ring, and other functional groups characteristic of aripiprazole.*

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Figure 1 (Opipza 02)

A chart illustrating the effect of various drugs on aripiprazole pharmacokinetics, showing fold changes and 90% confidence intervals for AUC and Cmax relative to reference without interacting drugs. It includes different categories such as CYP3A4 inhibitors (ketoconazole), CYP2D6 inhibitors (quinidine), CYP3A4 inducers (carbamazepine), gastric acid blockers (famotidine), and other drugs (valproate, lithium, lorazepam). The x-axis measures change relative to reference values ranging from 0.5 to 3.0.*

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Figure 2 (Opipza 03)

A pharmacokinetic chart illustrating the effect of various drugs on aripiprazole's dehydro-aripiprazole fold change and 90% confidence interval. The x-axis shows change relative to reference without interacting drug, ranging from 0.5 to 3.0. The y-axis lists drug categories and specific drugs, including CYP3A4 and CYP2D6 inhibitors and inducers, gastric acid blockers, and others, with corresponding data points for AUC and Cmax changes.*

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Figure 3 (Opipza 04)

A graph illustrating the effect of Aripiprazole on other drugs, showing fold changes and 90% confidence intervals relative to a reference without interacting drug. The chart plots changes in pharmacokinetic parameters such as AUC, Cmax, INR, and DMDP for various drugs including dextromethorphan, warfarin, omeprazole, lamotrigine, valproate, lithium, lorazepam, venlafaxine, O-desmethylvenlafaxine, and escitalopram, across different metabolizing enzymes and pathways like CYP2D6, CYP2C9/2C19, and UGT1A4.*

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Figure 4 (Opipza 05)

A pharmacokinetic chart showing Aripiprazole fold change with 90% confidence intervals across specific populations. The chart compares changes in AUC and Cmax between groups such as CYP2D6 poor versus extensive metabolizers, gender differences, age groups, varying degrees of hepatic impairment, and severe renal impairment, relative to reference values.*

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Figure 5 (Opipza 06)

A chart depicting the fold change and 90% confidence interval of dehydro-aripiprazole levels relative to reference across different factors including CYP2D6 metabolizer status, gender, age, hepatic impairment severity, and severe renal impairment. The chart uses squares and horizontal error bars to represent mean values and confidence intervals for AUC and Cmax parameters on a logarithmic scale.*

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Figure 6 (Opipza 07)

A Kaplan-Meier survival curve graph showing the proportion of subjects with relapse over days from randomization, comparing Aripiprazole and placebo groups. The graph includes a risk table indicating the number of subjects at risk for each group at various time points up to 182 days.*

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Figure 7 (Opipza 08)

Line graph showing the least-squares mean change from baseline in YGTSS total tic score over weeks of treatment. The graph compares three groups: Aripiprazole low dose, Aripiprazole high dose, and placebo, with scores decreasing more over time in the Aripiprazole groups compared to placebo.*

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Figure A (Opipza 09)

OPIPZA oral films by Carwin Pharmaceutical Associates, LLC, in 2 mg, 5 mg, and 10 mg strengths of aripiprazole. Each label shows a single oral film with instructions not to cut or chew, and to keep the product in the foil pouch until ready for use. The labels are color-coded: pink for 2 mg, blue for 5 mg, and orange for 10 mg.*

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Figure B (Opipza 10)

An instructional illustration showing hand hygiene steps: the first circle depicts hands being washed under running water with soap lather, and the second circle shows hands being dried with a towel or cloth.*

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Figure C (Opipza 11)

An instructional diagram showing how to open a packaging slit. The illustration includes arrows indicating a fold and tear motion to open the package, along with the text 'TO OPEN' and 'Slit is here' pointing to the perforated area.*

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Figure D (Opipza 12)

Instructional illustration showing a hand peeling a single-dose soluble film from a backing, demonstrating how to open the product unit for oral administration.*

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Figure E (Opipza 13)

An instructional illustration showing two steps for oral administration of a soluble film medication. The first image depicts a person placing the film on the tongue using their fingers. The second image shows a side profile of the mouth, indicating the film dissolving inside.*

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Principal Display Panel (2 mg Film Pouch Carton)

OPIPZA 2 mg oral film packaging label for aripiprazole by Carwin Pharmaceutical Associates, LLC. The label indicates an oral, soluble film dosage form containing 2 mg of aripiprazole per film, with 30 pouches each containing one oral film. It features storage instructions, a barcode, and directions for use including precautions not to cut or chew the film.*

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Principal Display Panel (5 mg Film Pouch Carton)

OPIPZA 5 mg oral film packaging label for aripiprazole by Carwin Pharmaceutical Associates, LLC. The box contains 30 pouches, each with 1 soluble oral film. The label includes a warning not to cut or chew the oral film and instructs pharmacists to dispense the enclosed Medication Guide. The packaging displays the product name, strength, dosage form, and a barcode.*

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Principal Display Panel (10 mg Film Pouch Carton)

Carton packaging for OPIPZA 10 mg (aripiprazole) oral film by Carwin Pharmaceutical Associates, LLC. The design features white and orange colors with the product name, strength, and dosage form prominently displayed. It states 30 pouches, each containing one oral film, with precautionary instructions such as not to cut or chew the film and to dispense the enclosed medication guide.*

* 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.