Lybalvi Tablet, Film Coated
Product Images NDC 65757-653

Product Visual Gallery

This gallery contains 20 technical images submitted to the FDA as part of the official labeling for Lybalvi (NDC 65757-653). 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.

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Lyb01 0004 01

Chemical structure diagram of olanzapine and samidorphan l-malate, showing the molecular framework with heterocyclic rings and functional groups as depicted.*

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Lyb01 0004 02

Chemical structure of olanzapine and samidorphan l-malate, showing the molecular arrangement of atoms and bonds for these active ingredients in the drug product.*

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Lyb01 0004 03

A scatter plot with horizontal error bars depicting fold changes and 90% confidence intervals for olanzapine and samidorphan maximum concentration (Cmax) and area under the curve (AUC) relative to healthy controls. The graph compares moderate hepatic impairment and severe renal impairment groups on the y-axis against changes relative to healthy control on the x-axis, ranging from 0 to 4.*

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Lyb01 0004 04

A chart depicting the geometric mean ratio and 90% confidence intervals of olanzapine and samidorphan l-malate under the influence of the strong CYP3A4 inducer rifampin. The variables measured are Cmax and AUC, with changes relative to a reference without rifampin shown on the horizontal axis.*

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Lyb01 0004 05

A chart depicting the geometric mean ratio and 90% confidence intervals for Lithium and Valproate Cmax and AUC12h, showing changes relative to a reference without LYBALVI. The x-axis represents the change relative to reference, while the y-axis labels the analytes and parameters measured.*

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Lyb01 0004 06

A line graph depicting the change in PANSS Total Score over 4 weeks for placebo, olanzapine, and LYBALVI groups. The y-axis shows change in score, and the x-axis shows weeks. The chart includes data points with error bars and a corresponding table of sample sizes per group per week below the graph.*

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Lyb01 0004 07

Line graph depicting percent change in body weight over 24 weeks for olanzapine and LYBALVI. The x-axis represents the weeks (0 to 24), and the y-axis shows the percent change in body weight. Data points with error bars indicate weight changes, with LYBALVI showing consistently lower weight increases than olanzapine.*

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Lyb01 0004 08

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Lyb01 0004 09

Packaging label for Lybalvi tablets containing olanzapine and samidorphan l-malate at 5 mg/10 mg strength. The label shows the product name, active ingredients, and dosage form as film-coated tablets. The package contains 7 tablets and is labeled for Rx use only. The labeler is Alkermes, Inc., with storage and ingredient information included.*

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Lyb01 0004 10

Packaging label for LYBALVI tablets, showing olanzapine and samidorphan 10 mg/10 mg film-coated tablets. The box contains 7 tablets and is distributed by Alkermes, Inc. The label includes storage instructions, inactive ingredients, and a barcode. The design features blue and copper-colored swoosh graphics.*

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Lyb01 0004 11

Box packaging label for Lybalvi tablets containing olanzapine and samidorphan at strengths of 15 mg and 10 mg respectively. The label indicates 7 tablets per bottle, manufactured by Alkermes, Inc. It includes a note to dispense the accompanying medication guide and lists inactive ingredients such as colloidal silicon dioxide and magnesium stearate. The label also provides storage instructions and contact information for support.*

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Lyb01 0004 12

Packaging label for Lybalvi 20 mg/10 mg film-coated tablets containing olanzapine and samidorphan. The box includes the product name, strength, dosage form, quantity of 7 tablets, and the labeler Alkermes, Inc. Additional information includes inactive ingredients, storage instructions, and a barcode.*

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Lyb01 0004 13

Packaging label for LYBALVI tablets containing olanzapine and samidorphan, 5 mg/10 mg strength, produced by Alkermes, Inc. The label states the package contains 30 film-coated tablets, includes storage instructions, and lists inactive ingredients. The design features the product name, dosage strength highlighted in yellow, company logo, barcode, and a note to dispense the accompanying Medication Guide.*

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Lyb01 0004 14

Packaging label for LYBALVI tablets containing 10 mg olanzapine and 10 mg samidorphan. The film-coated tablet box holds 30 tablets and is labeled for prescription use only. Distributed by Alkermes, Inc., the label includes dosage information, storage instructions, inactive ingredients, and a barcode.*

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Lyb01 0004 15

Packaging label for LYBALVI tablets containing olanzapine and samidorphan at 15 mg/10 mg strength. The label indicates a quantity of 30 film-coated tablets and includes dosage, storage instructions, and inactive ingredient information. The product is distributed by Alkermes, Inc., and features branding with a blue and copper swoosh design.*

FDA Label Image

Lyb01 0004 16

Packaging label for LYBALVI tablets containing 20 mg olanzapine and 10 mg samidorphan. The film-coated tablets come in a bottle of 30, distributed by Alkermes, Inc. The label includes storage instructions, inactive ingredients, and contact information for support. The design features the LYBALVI logo and dosage prominently on a white background with blue and copper-colored swooshes.*

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Lyb01 0004 17

Packaging label for LYBALVI tablets containing 5 mg olanzapine and 10 mg samidorphan. The label shows the product name, active ingredients, dosage strength, and package count of 90 tablets. It includes storage instructions, a barcode, inactive ingredient list, and Alkermes, Inc. as the distributor.*

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Lyb01 0004 18

Packaging label for LYBALVI 10 mg/10 mg tablets, containing olanzapine and samidorphan. The label indicates 90 film-coated tablets per package, distributed by Alkermes, Inc. It includes storage instructions, inactive ingredients, and a medication guide notice. The design features a wavy orange and blue stripe across a white background with the product name and strength prominently displayed.*

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Lyb01 0004 19

Carton label for LYBALVI tablets containing olanzapine and samidorphan. The strength is 15 mg olanzapine and 10 mg samidorphan per tablet. The package contains 90 film-coated tablets and is labeled for Rx only. The label includes manufacturer information for Alkermes, Inc., storage instructions, and a barcode.*

FDA Label Image

Lyb01 0004 20

Packaging label for LYBALVI tablets containing olanzapine and samidorphan L-malate. The strength shown is 20 mg olanzapine / 10 mg samidorphan per tablet. The label indicates a count of 90 film-coated tablets per package. The labeler is Alkermes, Inc., with storage and ingredient information provided.*

* 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.