Trintellix Tablet, Film Coated
Product Images NDC 70518-4284

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Trintellix (NDC 70518-4284). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Remedyrepack 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

Remedy_label (Remedy Label)

Packaging label for Trintellix 10 mg film-coated tablets, containing 30 tablets per box. The label lists vortioxetine as the active ingredient and is labeled for Rx only. Manufactured by Takeda in Deerfield, IL, and repackaged by RemedyRepack Inc. in Indiana, PA. Storage instructions and other regulatory information are included.*

FDA Label Image

Mm2 (Trintellix 10mg 70518 4284 01)

Label for Trintellix 10 mg oral film-coated tablet by RemedyRepack Inc. The label indicates a single tablet quantity and includes the NDC 70518-4284-01. Manufacturer information states Takeda, Deerfield, IL. Storage instructions and a barcode are also visible.*

FDA Label Image

Chemical Structure (Trintellix 01)

Chemical structure diagram of vortioxetine hydrobromide, the active ingredient in Trintellix 10 mg tablets. The diagram shows the molecular framework with nitrogen, sulfur atoms, and hydrobromide salt indicated.*

FDA Label Image

Figure 1 (Trintellix 02)

A forest plot chart showing pharmacokinetic fold changes with 90% confidence intervals for vortioxetine (Trintellix) across different population groups including age, gender, race, renal impairment, ESRD, and hepatic impairment, comparing AUC and Cmax relative to reference values.*

FDA Label Image

Figure 2 (Trintellix 03)

A chart showing the fold change and 90% confidence intervals of various interacting drugs on vortioxetine pharmacokinetics (AUC and Cmax). It categorizes drugs as CYP2D6 inhibitor, CYP inducer, CYP3A/Pgp inhibitor, CYP2C9/2C19/3A inhibitor, CYP2C19 inhibitor, and others, illustrating their relative effect compared to vortioxetine alone.*

FDA Label Image

Figure 3 (Trintellix 04)

A forest plot chart displaying fold changes and 90% confidence intervals in pharmacokinetic parameters (AUC and Cmax) for various interacting drugs metabolized by CYP2B6, CYP2C9, CYP2C19, CYP3A, and other substrates. The horizontal axis represents the change relative to the interacting drug alone, ranging from 0.50 to 1.50. Specific drugs like Bupropion, Warfarin, Diazepam, Omeprazole, Ethinyl estradiol, Levonorgestrel, Aspirin, Ethanol, and Lithium are listed alongside their respective fold changes.*

FDA Label Image

Figure 4 (Trintellix 05)

A line graph showing change from baseline over study visits in weeks for three groups: Placebo, Trintellix 10 mg, and Trintellix 20 mg. The vertical axis represents change from baseline, and the horizontal axis represents study visit weeks from 0 to 8. The Trintellix groups show greater declines compared to placebo over time.*

FDA Label Image

Figure 5 (Trintellix 06)

A forest plot chart displaying results from six studies comparing different doses of Trintellix (vortioxetine) ranging from 5mg to 20mg. The x-axis represents the difference from placebo, with markers and confidence intervals indicating effectiveness, where values to the left indicate better outcomes than placebo. Studies include both US and non-US populations, plus an elderly subgroup.*

FDA Label Image

Figure 6 (Trintellix 07)

A Kaplan-Meier survival curve chart comparing the proportion of patients with recurrence over time (in weeks) for Trintellix (5 or 10 mg) versus placebo. The graph plots recurrence percentage against time to recurrence, with Trintellix showing a lower proportion of recurrence compared to placebo. Patient counts maintained over time are listed below the x-axis for both groups.*

FDA Label Image

Figure 7 (Trintellix 08)

A line graph showing the proportion of patients with recurrence (%) over time to recurrence (weeks) for Trintellix 5 mg, 10 mg, 20 mg, and placebo groups. The x-axis represents time in weeks up to 32 weeks, and the y-axis represents the proportion of patients with recurrence up to 40%. A legend identifies four curves: placebo, 5 mg, 10 mg, and 20 mg dosages of Trintellix. Below the graph, a table lists the number of patients maintained at multiple time points for each group.*

FDA Label Image

Figure 8 (Trintellix 09)

A line graph comparing the improvement from baseline over time between Trintellix (vortioxetine) and Escitalopram, both at 10 or 20 mg doses. The y-axis represents the change from baseline (improvement), and the x-axis represents time in weeks up to 8 weeks. Trintellix shows a consistently higher improvement than Escitalopram throughout the period.*

FDA Label Image

Figure 9 (Trintellix 10)

Line chart showing change from baseline over a 5-week study visit period for Placebo, Trintellix 10 mg, Trintellix 20 mg, and Paroxetine 20 mg. The y-axis represents change from baseline, indicating worsening, while the x-axis represents study visit weeks from 0 to 5. Different lines illustrate varying responses of each treatment over time.*

* 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.