Auvelity Tablet, Multilayer, Extended Release
Product Images NDC 81968-030

Product Visual Gallery

This gallery contains 20 technical images submitted to the FDA as part of the official labeling for Auvelity (NDC 81968-030). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Axsome Therapeutics, 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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Structural Formula (Dextromethorphan Hydrobromide)

Chemical structure of dextromethorphan hydrobromide monohydrate, showing a complex bicyclic framework with a methoxy-substituted aromatic ring, consistent with the active ingredient in AUVELITY tablets.*

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Structural Formula (Bupropion Hydrochloride)

Chemical structure of dextromethorphan hydrobromide, shown with a chlorophenyl ring, ketone group, and an amine group attached to a methylated backbone, along with a hydrochloride salt.*

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Figure 1 (Auvelity 03)

A forest plot titled 'Mean Effect and 90% CI' showing change relative to reference for four pharmacokinetic parameters (DM AUC, DM Cmax, BUP AUC, BUP Cmax) under three conditions: Moderate Renal Impairment, Moderate Hepatic Impairment, and CYP2D6 Poor Metabolizers. The plot presents point estimates with horizontal lines representing 90% confidence intervals, illustrating variability in drug exposure compared to reference groups.*

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Figure 2 (Auvelity 04)

A forest plot showing the mean effect and 90% confidence intervals of CYP2D6 and CYP2B6 inhibitors and inducers on pharmacokinetic parameters of dextromethorphan (DM) and bupropion (BUP). The chart compares changes in AUC and Cmax relative to a reference for paroxetine, clopidogrel, and carbamazepine at specified doses.*

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Figure 3 (Auvelity 05)

A line graph comparing the LS mean change from baseline in MADRS Total Score over 6 weeks between AUVELITY and placebo groups. The vertical axis shows score changes, and the horizontal axis shows time in weeks. AUVELITY shows a greater decrease in MADRS scores compared to placebo across the study period, with sample sizes for each group indicated below the graph.*

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Figure 4 (Auvelity 06)

Label for Auvelity extended-release multilayer tablets containing 45 mg dextromethorphan hydrobromide and 105 mg bupropion hydrochloride. The label shows the product name, active ingredients with strengths, dosage form, NDC 81968-045-30, container size of 30 tablets, and manufacturer Axsome Therapeutics, Inc. Storage and handling instructions are also provided.*

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Figure 5 (Auvelity 07)

A Kaplan-Meier curve chart showing the percentage of patients with a relapse over 28 weeks since randomization, comparing AUVELITY and placebo groups. The x-axis represents weeks since randomization, while the y-axis shows the percentage of patients relapsing. AUVELITY has a lower relapse rate than placebo throughout the study period. A risk table below the graph lists the number of patients at risk each week for both groups.*

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30-count Bottle Label (Auvelity 45 105 30ct Bottle)

Label for AUVELITY extended-release tablets containing 45 mg dextromethorphan hydrobromide and 105 mg bupropion hydrochloride per tablet. The oral multilayer tablets are packaged 30 count and labeled for prescription use by Axsome Therapeutics, Inc. The label includes storage instructions, dosage form, manufacturer location, and a statement that the product is not for individual sale.*

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Image Description (Image0004)

Label for Auvelity 45 mg/105 mg extended-release multilayer oral tablets containing dextromethorphan hydrobromide and bupropion hydrochloride. The label states prescription use only with 60 tablets per container. It includes storage instructions, a barcode, manufacturer details (Axsome Therapeutics, Inc.), and a note to dispense with the Medication Guide.*

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30-count Physician Sample Bottle Label (Image0002)

Label for Auvelity extended-release tablets containing 45 mg dextromethorphan hydrobromide and 105 mg bupropion hydrochloride. The label indicates 30 tablets per bottle for oral use, specifies storage instructions, and includes manufacturer information for Axsome Therapeutics, Inc. The label states the product is a patient sample and not for sale, with NDC 81968-045-31.*

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30-count Physician Sample Carton Label (Image0003)

Packaging label for Auvelity 45 mg/105 mg extended-release multilayer oral tablets by Axsome Therapeutics, Inc. The carton indicates 30 tablets for oral use, labeled as a patient sample with Rx only. It features product details, NDC 81968-045-31, and storage instructions. The design includes a dark blue background with yellow and white text and geometric shapes.*

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14-count Physician Sample Bottle Label (Image0005)

Label for Auvelity 45 mg/105 mg extended-release multilayer oral tablets by Axsome Therapeutics, Inc. The label indicates this is a prescription drug, patient sample, not for sale, containing 14 tablets. It lists the active ingredients amounts, storage instructions, and the NDC 81968-045-14.*

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14-count Physician Sample Carton Label (Image0006)

Carton label for Auvelity 45 mg/105 mg extended-release multilayer oral tablets by Axsome Therapeutics, Inc. The label designates the product as a patient sample, with 14 tablets for oral use. Details include active ingredients dextromethorphan HBr and bupropion HCl, lot and expiration placeholders, Rx only status, storage instructions, and a barcode. The packaging has a dark blue and white color scheme with yellow accent text.*

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21-count Physician Sample Carton Label (30mg/105mg) (Image0007)

Carton label for AUVELITY 30 mg/105 mg extended-release multilayer tablets containing dextromethorphan HBr and bupropion HCl. The label states it is a patient sample for agitation associated with dementia due to Alzheimer's disease, for titration use only, and not for sale. The label includes storage and administration instructions and is from Axsome Therapeutics, Inc.*

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21-count Physician Sample Bottle Label (30mg/105mg) (Image0008)

AUVELITY 30 mg/105 mg extended-release multilayer tablets packaging label. The oral tablet contains dextromethorphan hydrobromide and bupropion hydrochloride. The label includes recommended storage instructions, manufacturer details (Axs ome Therapeutics, Inc.), and states the package contains 21 tablets for oral use. It also notes this is a patient sample and not for sale.*

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Titration Kit For Agitation Associated With Dementia Due To Ad (Auvelity Titration Kit Ada)

Packaging label for AUVELITY tablets, containing dextromethorphan hydrobromide and bupropion hydrochloride extended-release tablets. The label shows two strengths: 30 mg/105 mg in a 21-tablet count and 45 mg/105 mg in a 30-tablet count. It is a prescription drug for oral use, manufactured by Axsome Therapeutics, Inc. The label includes storage instructions, a barcode, and cautionary statements about use and dispensing.*

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21-count Carton Label (30mg/105mg) (Auvelity 30 105 21 Ct Carton)

AUVELITY 30 mg/105 mg extended-release multilayer tablets carton with detailed labeling. The packaging shows the product name, active ingredients (dextromethorphan HBr and bupropion HCl), dosage strength, and instructions including 'Not For Individual Sale' and 'Rx only.' The labeler is Axsome Therapeutics, Inc., with additional storage information and manufacturing details. The carton design includes a yellow and white color scheme with the AUVELITY logo.*

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21-count Bottle Label (30mg/105mg) (Auvelity 30 105 21ct Bottle)

AUVELITY 30 mg/105 mg extended-release multilayer tablets containing dextromethorphan hydrobromide and bupropion hydrochloride. The label shows drug contents, storage instructions, and dosage form. The package contains 21 tablets and is for oral use only, labeled by Axsome Therapeutics, Inc.*

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Physician Sample Titration Kit For Agitation Associated With Dementia Due To Adiption (Auvelity Titration Sample Kit Ada)

Flat carton packaging for AUVELITY, a prescription multilayer extended-release tablet containing dextromethorphan hydrobromide and bupropion hydrochloride. The patient sample titration pack includes tablets in strengths of 30 mg/105 mg and 45 mg/105 mg. The label highlights use for agitation associated with dementia due to Alzheimer's disease and is labeled for oral use. Manufactured by Axsome Therapeutics, Inc.*

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81968-453-01 (Auvelity Titration Sample Kit Ada 453 01.jpg)

Packaging label for AUVELITY extended-release tablets, containing dextromethorphan hydrobromide and bupropion hydrochloride. The label details a patient sample titration pack with titration and maintenance bottles. The titration bottle contains 30 mg/105 mg strength tablets, and the maintenance bottle contains 45 mg/105 mg strength tablets. Labeler is Axsome Therapeutics, Inc, with instructions on dosing over three weeks and storage guidance.*

* 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.