Simtriyo Capsule, Extended Release
Product Images NDC 59148-304

8 FDA label images from Otsuka America Pharmaceutical, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Simtriyo (NDC 59148-304). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Otsuka America Pharmaceutical, 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

Chemical Structure (Simtriyo 01)

Chemical Structure (Simtriyo 01)
Chemical structure of centanafadine hydrochloride, depicted with a bicyclic aromatic ring and a bridged nitrogen-containing ring, indicating the molecule's specific atomic connectivity and arrangement.*
FDA Label Image

Figure 1 (Simtriyo 02)

Figure 1 (Simtriyo 02)
Line chart comparing the least squares mean change from baseline with standard error over 6 weeks between Placebo and SIMTRIYO 280 mg extended-release capsules. The vertical axis shows change from baseline, and the horizontal axis indicates time in weeks. The chart includes patient numbers for each group at each time point.*
FDA Label Image

Figure 2 (Simtriyo 03)

Figure 2 (Simtriyo 03)
A line graph comparing LS mean change from baseline in a clinical measure over 6 weeks between placebo and SIMTRIYO 280 mg. The y-axis shows the LS mean change from baseline (SE), with the SIMTRIYO 280 mg group showing greater decrease than placebo over time. The x-axis represents time in weeks from 0 to 6. Patient numbers at each time point are listed below the x-axis.*
FDA Label Image

Figure 3 (Simtriyo 04)

Figure 3 (Simtriyo 04)
A line graph showing the least squares mean change from baseline (SE) over 42 days comparing placebo with two other centanafadine formulations (low dose and high dose). The x-axis represents time in days, and the y-axis shows the change from baseline. Data points include error bars and the number of patients for each group at each time point is tabulated below the graph.*
FDA Label Image

Figure 4 (Simtriyo 05)

Figure 4 (Simtriyo 05)
A line graph comparing the least squares mean change from baseline (with standard error bars) over 42 days for placebo and two different doses of another centanafadine formulation. The x-axis represents time in days, and the y-axis shows the change from baseline. The graph also includes a table below showing the number of patients for each group at various time points.*
FDA Label Image

Principal Display Panel (140 mg Capsule Bottle Label)

Principal Display Panel (140 mg Capsule Bottle Label)
SIMTRIYO 140 mg extended-release capsules label showing the drug's proprietary name and strength prominently. The label notes the active ingredient centanafadine hydrochloride and its equivalent dosage. It includes usage instructions, storage conditions, a medication guide reminder, package quantity of 30 capsules, and manufacturer information for Otsuka America Pharmaceutical, Inc. A barcode and product identifiers are also visible.*
FDA Label Image

Principal Display Panel (210 mg Capsule Bottle Label)

Principal Display Panel (210 mg Capsule Bottle Label)
SIMTRIYO 210 mg extended-release capsules label showing the product name, generic name centanafadine hydrochloride, dosage strength of 210 mg, and quantity of 30 capsules. The label includes storage instructions, a barcode, and manufacturer information for Otsuka America Pharmaceutical, Inc.*
FDA Label Image

Principal Display Panel (280 mg Capsule Bottle Label)

Principal Display Panel (280 mg Capsule Bottle Label)
SIMTRIYO 280 mg extended-release capsules label showing the proprietary name, generic name centanafadine hydrochloride, and dosage strength. The label indicates 30 capsules per container, with storage instructions and manufacturer details for Otsuka America Pharmaceutical, Inc. It includes a caution to dispense the Medication Guide to each patient, NDC code 59148-304-13, and a barcode.*

* 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.