Auvelity Kit
Product Images NDC 81968-453

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Auvelity (NDC 81968-453). 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.

FDA Label Image

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.*

FDA Label Image

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.*

FDA Label Image

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.*

FDA Label Image

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.*

FDA Label Image

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.*

FDA Label Image

30-count Bottle Label (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.*

* 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.