Lisdexamfetamine Dimesylate Capsule
Product Images NDC 0406-5115

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Lisdexamfetamine Dimesylate (NDC 0406-5115). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Specgx Llc, 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 (Lisdexamfetamine Dimesylate 1)

Chemical structure of Lisdexamfetamine Dimesylate showing the molecular arrangement of its atoms, including phenyl and amide groups along with two mesylate counterions depicted on the right.*

FDA Label Image

Principal Display Panel (10 mg Capsules)

Lisdexamfetamine Dimesylate 10 mg capsules, packaging label showing a bottle container for 100 capsules. The label includes dosage strength, manufacturer SpecGx LLC, directions to dispense the Medication Guide, storage instructions, and Rx only status. The label also features a barcode and a QR code.*

FDA Label Image

Principal Display Panel (20 mg Capsules)

Label for Lisdexamfetamine Dimesylate 20 mg capsules by SpecGx LLC. The label indicates 100 capsules in the package, with the dosage strength prominently displayed. It includes a capsule image marked 'M 5112 20 mg' and notes the medication guide dispensing requirement. Storage instructions and manufacturing details in Webster Groves, MO, are also present.*

FDA Label Image

Principal Display Panel (30 mg Capsules)

Lisdexamfetamine Dimesylate 30 mg oral capsules packaging label showing 100 capsules per container. The label includes a barcode, NDC number 0406-5113-01, and states the product is prescription only. Manufactured by SpecGx LLC, it instructs pharmacists to dispense the Medication Guide to patients. The label also notes storage conditions and provides a dosage reference to the package insert.*

FDA Label Image

Principal Display Panel (40 mg Capsules)

Label for Lisdexamfetamine Dimesylate 40 mg capsules by SpecGx LLC. The label indicates a bottle of 100 capsules. It includes storage instructions, dosage reference, and a pharmacist dispensing note. The label shows a green capsule image marked with dosage details and a barcode on the left side.*

FDA Label Image

Principal Display Panel (50 mg Capsules)

Label for Lisdexamfetamine Dimesylate 50 mg capsules by SpecGx LLC. The label indicates the product contains 100 capsules, with each capsule containing 50 mg of Lisdexamfetamine Dimesylate. Storage instructions and dispensing requirements are also noted, including pharmacist directions to provide a medication guide. The label includes an NDC barcode and lot/expiration placeholders.*

FDA Label Image

Principal Display Panel (60 mg Capsules)

Lisdexamfetamine Dimesylate 60 mg capsules packaging label showing a blister of 100 capsules. The label includes the drug name, strength, dosage form, and instructions for pharmacists to dispense the medication guide. It lists storage conditions, manufacturer SpecGx LLC in Webster Groves, MO, and a barcode. The label features a lavender background with black and white text, including a capsule image.*

FDA Label Image

Principal Display Panel (70 mg Capsules)

Label for Lisdexamfetamine Dimesylate 70 mg capsules by Mallinckrodt, containing 100 capsules. The label shows dosage strength, a capsule image with imprint 'M 5117 70mg', packaging details, storage instructions, and manufacturer SpecGx LLC. It includes Rx only and dosing guidance to see package insert.*

FDA Label Image

Figure 1 (Lisdexamfetamine Dimesylate 2)

A scatter plot showing fold change and 90% confidence intervals for pharmacokinetic parameters (Cmax and AUC) of Lisdexamfetamine Dimesylate in special populations including gender, age groups (65-74 years and 75+ years), and varying renal impairment levels from mild to end stage renal disease, relative to a reference value.*

FDA Label Image

Figure 2 (Lisdexamfetamine Dimesylate 3)

A forest plot chart displaying fold change and 90% confidence intervals for pharmacokinetic parameters (Cmax and AUC) relative to reference values for Guanfacine, Venlafaxine, and Omeprazole, illustrating their impact on drug exposure.*

FDA Label Image

Figure 3 (Lisdexamfetamine Dimesylate 4)

A chart depicting fold change and 90% confidence intervals in pharmacokinetic parameters (Cmax and AUC) for various interacting drugs including Guanfacine, Venlafaxine, caffeine (CYP1A2 substrate), Dextromethorphan (CYP2D6 substrate), Omeprazole (CYP2C19 substrate), and Midazolam (CYP3A substrate). The x-axis shows change relative to reference ranging from 0.0 to 2.0.*

FDA Label Image

Figure 4 (Lisdexamfetamine Dimesylate 5)

Line graph comparing LS Mean (SE) SKAMP Deportment Scores over time post-dose (hours) between Lisdexamfetamine Dimesylate Capsules and placebo. The x-axis represents time in hours post-dose from -0.5 to 13 hours, and the y-axis shows SKAMP Deportment Scores from 0.0 to 2.0. Error bars are included for each data point.*

FDA Label Image

Figure 5-1 (Lisdexamfetamine Dimesylate 6)

A Kaplan-Meier curve comparing the proportion of subjects with relapse or treatment failure over time (days after randomization) between Lisdexamfetamine Dimesylate capsules and placebo groups. The graph shows lower relapse rates in the Lisdexamfetamine Dimesylate group compared to placebo over approximately 45 days.*

FDA Label Image

Figure 6 (Lisdexamfetamine Dimesylate 7)

This line graph compares the LS Mean (SE) PERMP Total Scores over Time Post-Dose (hours) for Placebo versus Lisdexamfetamine Dimesylate Capsules. The x-axis represents time in hours from -0.5 to 14, and the y-axis represents the total scores ranging from 250 to 330. Two lines with error bars display score trends for both Placebo (dashed line) and Lisdexamfetamine Dimesylate Capsules (solid line).*

FDA Label Image

Figure 7 (Lisdexamfetamine Dimesylate 8)

A line graph showing the proportion of subjects with relapse or treatment failure (%) over time (days after randomization) for Lisdexamfetamine Dimesylate Capsules versus placebo. The graph displays two curves: a solid line for lisdexamfetamine with a consistently low proportion of relapse/treatment failure and a dashed line for placebo showing a higher and increasing proportion over time up to 35 days.*

FDA Label Image

Figure 8 (Lisdexamfetamine Dimesylate 9)

A Kaplan-Meier curve comparing the proportion of subjects with relapse over time between Lisdexamfetamine Dimesylate Capsules and placebo. The solid line represents Lisdexamfetamine Dimesylate Capsules showing lower relapse rates, while the dashed line represents placebo with higher relapse rates. The x-axis indicates time in days after randomization, and the y-axis shows the proportion of subjects with relapse as a percentage. The number of subjects at risk at various time points is provided below the graph for both groups.*

* 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.