Trintellix Tablet, Film Coated
Product Images NDC 64764-750

13 FDA label images from Takeda Pharmaceuticals America, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Trintellix (NDC 64764-750). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Takeda Pharmaceuticals America, 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

Figure 1 (Trintellix 01)

Figure 1 (Trintellix 01)
Chemical structure of vortioxetine hydrobromide, the active ingredient in Trintellix. The diagram shows the molecular structure including piperazine and substituted phenyl rings.*
FDA Label Image

Figure 2 (Trintellix 02)

Figure 2 (Trintellix 02)
A forest plot chart showing pharmacokinetic parameters (AUC and Cmax) presenting fold change and 90% confidence intervals for Trintellix (vortioxetine) across different population subgroups. The subgroups include age groups, gender, race, renal impairment levels, and hepatic impairment levels, comparing each to a reference group. The horizontal axis represents change relative to reference.*
FDA Label Image

Figure 3 (Trintellix 03)

Figure 3 (Trintellix 03)
A chart depicting the pharmacokinetic interactions of various drugs with vortioxetine, showing fold changes and 90% confidence intervals in AUC and Cmax relative to vortioxetine alone. It includes data for CYP2D6 inhibitor (Bupropion), CYP inducer (Rifampin), CYP3A/Pgp inhibitor (Ketoconazole), CYP2C9/2C19/3A inhibitor (Fluconazole), CYP2C19 inhibitor (Omeprazole), and others such as Ethanol and Aspirin.*
FDA Label Image

Chemical Structure (Trintellix 04)

Chemical Structure (Trintellix 04)
A forest plot chart illustrating the pharmacokinetic effects of vortioxetine on various interacting drugs categorized by CYP substrates and others. It shows fold changes with 90% confidence intervals for AUC and Cmax parameters relative to each interacting drug alone, including drugs like bupropion, (S)-warfarin, diazepam, omeprazole, ethynil estradiol, levonorgestrel, aspirin, ethanol, and lithium.*
FDA Label Image

Figure 4 (Trintellix 05)

Figure 4 (Trintellix 05)
Line graph showing change from baseline over 8 weeks of study visits comparing placebo, Trintellix 10 mg, and Trintellix 20 mg. The graph indicates a greater decrease from baseline with both Trintellix doses compared to placebo across the study period.*
FDA Label Image

Figure 5 (Trintellix 06)

Figure 5 (Trintellix 06)
A horizontal bar chart showing differences from placebo in multiple clinical studies of Trintellix tablets at various doses (5 mg, 10 mg, 15 mg, 20 mg). Studies include US, non-US, and elderly populations. The x-axis ranges from -12 to 3, with negative values indicating better outcomes than placebo. Each study compares two doses, with data points and error bars representing differences from placebo.*
FDA Label Image

Figure 6 (Trintellix 07)

Figure 6 (Trintellix 07)
A line graph depicting the proportion of patients with recurrence (%) over time to recurrence (weeks) comparing Trintellix 5 or 10 mg with placebo. The graph shows a lower recurrence rate for Trintellix over 32 weeks, with patient numbers maintained for both groups detailed below the x-axis.*
FDA Label Image

Principal Display Panel (5 mg Tablet Bottle Label)

Principal Display Panel (5 mg Tablet Bottle Label)
A line graph comparing the proportion of patients with recurrence over time (up to 32 weeks) among placebo and Trintellix (vortioxetine) 5 mg, 10 mg, and 20 mg oral tablet groups. The x-axis shows time to recurrence in weeks, and the y-axis shows the percentage of patients with recurrence. Below the graph is a table indicating patient numbers maintained at various time points for each group.*
FDA Label Image

Principal Display Panel (10 mg Tablet Bottle Label)

Principal Display Panel (10 mg Tablet Bottle Label)
A line graph comparing changes from baseline in improvement over an 8-week study period. The x-axis represents study visits by week (0 to 8), and the y-axis indicates the degree of improvement. Two lines are shown: one for Trintellix (vortioxetine) at 10 or 20 mg dosages and one for escitalopram at 10 or 20 mg dosages. The graph shows higher improvement scores for Trintellix compared to escitalopram across weeks.*
FDA Label Image

Trintellix 10

Trintellix 10
A line graph showing change from baseline over weeks of a study visit, comparing Placebo, Trintellix 10 mg, Trintellix 20 mg, and Paroxetine 20 mg. The vertical axis represents change from baseline with worsening downward, and the horizontal axis shows weeks 0 to 5. Lines indicate that Trintellix and Paroxetine groups exhibit a greater decrease from baseline compared to placebo over time.*
FDA Label Image

Principal Display Panel (20 mg Tablet Bottle Label)

Principal Display Panel (20 mg Tablet Bottle Label)
Label for Trintellix 5 mg vortioxetine tablets by Takeda Pharmaceuticals America, Inc. The label indicates the product contains thirty 5 mg film-coated tablets, with instructions to dispense with the Medication Guide. It includes tamper-evident warnings, storage recommendations, manufacturer details, and barcodes.*
FDA Label Image

Trintellix 12

Trintellix 12
Label for Trintellix vortioxetine tablets 10 mg by Takeda Pharmaceuticals America, Inc. The label states the product is Rx only, contains 30 film-coated tablets, and includes storage and tamper-evident information. The label also has dispensing instructions with a Medication Guide and distributor details for Lundbeck, Deerfield, IL.*
FDA Label Image

Trintellix 13

Trintellix 13
Trintellix 20 mg vortioxetine tablets film-coated oral medication label. The label includes branding by Takeda Pharmaceuticals America, Inc. and Lundbeck, dosage strength, tamper-evident warning, and storage instructions. The package contains 30 tablets and includes a barcode and the NDC number 64764-750-30.*

* 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.