Lisdexamfetamine Dimesylate Capsule
Product Images NDC 65162-028

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Lisdexamfetamine Dimesylate (NDC 65162-028). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Amneal Pharmaceuticals 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

8c301747-figure-01 (Lisdexamfetamine Dimesylate Capsules 1)

Chemical structure of lisdexamfetamine dimesylate, showing the molecular arrangement of lisdexamfetamine with two dimesylate groups.*

FDA Label Image

20 mg 90 Ct Label (Lisdexamfetamine Dimesylate Capsules 10)

Lisdexamfetamine Dimesylate Capsules 20 mg oral capsules packaging label from Amneal Pharmaceuticals LLC. The label shows a beige capsule marked with '20 23', includes storage instructions, and states the quantity as 90 capsules. It specifies dispensing conditions and manufacturer details from Amneal Pharmaceuticals of NY, LLC.*

FDA Label Image

30 mg 90 Ct Label (Lisdexamfetamine Dimesylate Capsules 11)

Lisdexamfetamine Dimesylate Capsules 30 mg label from Amneal Pharmaceuticals LLC. The label states the active ingredient amount per capsule, pharmacist dispensing instructions, storage conditions, and manufacturer and distributor information. The label includes a barcode and notes that the product is Rx only with a package count of 90 capsules.*

FDA Label Image

20 mg 90 Ct Label (Lisdexamfetamine Dimesylate Capsules 12)

Lisdexamfetamine Dimesylate Capsules 40 mg label showing a capsule image marked with '25' and '40'. The label includes pharmacist dispensing instructions, storage conditions, manufacturer Amneal Pharmaceuticals of NY, LLC, and distributor Amneal Pharmaceuticals LLC of KY. Packaging specifies 90 capsules, prescription only, with barcode and NDC 65162-025-09.*

FDA Label Image

50 mg 90 Ct Label (Lisdexamfetamine Dimesylate Capsules 13)

Lisdexamfetamine Dimesylate Capsules 50 mg label from Amneal Pharmaceuticals LLC. The label includes the drug name, strength, dosage form, NDC number, a color image of a blue and yellow capsule marked with '50' and '26', storage instructions, and distributor information. It indicates the package contains 90 capsules and that the drug is Rx only.*

FDA Label Image

60 mg 90 Ct Label (Lisdexamfetamine Dimesylate Capsules 14)

Packaging label for Lisdexamfetamine Dimesylate Capsules 60 mg by Amneal Pharmaceuticals LLC. The label indicates the capsules are for oral use and prescription only, supplied in a 90-count package. It includes storage instructions and manufacturer/distributor information.*

FDA Label Image

70 mg 90 Ct Label (Lisdexamfetamine Dimesylate Capsules 15)

Lisdexamfetamine Dimesylate Capsules label for 70 mg strength by Amneal Pharmaceuticals LLC. The label includes dosage information, storage instructions, manufacturer and distributor details, a barcode, and a colored capsule image. The package contains 90 capsules, indicated as Rx only.*

FDA Label Image

Figure 1 (Lisdexamfetamine Dimesylate Capsules 2)

A forest plot chart illustrating the fold change and 90% confidence intervals for Cmax and AUC pharmacokinetic parameters of Lisdexamfetamine in various special populations, including different genders, age groups (65-74 years and 75+ years), and renal impairment levels (mild, moderate, severe, and end stage renal disease). The chart shows the change relative to a reference value on the horizontal axis.*

FDA Label Image

2 (Lisdexamfetamine Dimesylate Capsules 3)

A chart showing fold change and 90% confidence intervals for pharmacokinetic parameters Cmax and AUC for three drugs: Guanfacine, Venlafaxine, and Omeprazole. The horizontal axis indicates change relative to reference, ranging from 0.0 to 2.0, with data points plotted for each parameter and drug combination.*

FDA Label Image

3 (Lisdexamfetamine Dimesylate Capsules 4)

A scatter plot graph showing fold change and 90% confidence intervals for pharmacokinetic parameters (Cmax and AUC) of various interacting drugs relative to reference levels. The interacting drugs listed include Guanfacine, Venlafaxine, CYP1A2 substrate Caffeine, CYP2D6 substrate Dextromethorphan, CYP2C19 substrate Omeprazole, and CYP3A substrate Midazolam. The x-axis represents change relative to reference ranging from 0.0 to 2.0.*

FDA Label Image

1 (Lisdexamfetamine Dimesylate Capsules 5)

A line graph comparing LS Mean (SEM) SKAMP Deportment Scores over time post-dose between placebo and lisdexamfetamine dimesylate. The x-axis represents time from -0.5 to 13 hours, and the y-axis shows scores from 0 to 2. Lisdexamfetamine dimesylate shows a decrease in scores after dosing compared to placebo, indicating a divergence in effect over time.*

FDA Label Image

Figure 5 (Lisdexamfetamine Dimesylate Capsules 6)

A line graph comparing the proportion of subjects with relapse or treatment failure over time (days after randomization) for Lisdexamfetamine Dimesylate versus placebo. The x-axis represents time in days, and the y-axis represents the proportion of subjects with relapse/treatment failure in percentage. The graph shows separate curves for Lisdexamfetamine Dimesylate and placebo.*

FDA Label Image

6 (Lisdexamfetamine Dimesylate Capsules 7)

A line graph comparing LS Mean (SE) PERMP Total Scores over time (hours post-dose) for Lisdexamfetamine dimesylate versus placebo. The x-axis shows time from -0.5 to 14 hours post-dose, and the y-axis shows PERMP total scores from 250 to 330. Lisdexamfetamine dimesylate demonstrates higher scores across the time points than placebo, with error bars indicating variability.*

FDA Label Image

7 (Lisdexamfetamine Dimesylate Capsules 8)

A Kaplan-Meier survival curve chart depicting the proportion of subjects with relapse or treatment failure over time in days after randomization. The chart compares two groups: one receiving Lisdexamfetamine dimesylate and one receiving placebo. The Lisdexamfetamine dimesylate group shows a much lower proportion of relapse/treatment failure across the observed period compared to the placebo group.*

FDA Label Image

Figure 8 (Lisdexamfetamine Dimesylate Capsules 9)

A Kaplan-Meier curve chart comparing the proportion of subjects with relapse over time (days after randomization) for Lisdexamfetamine dimesylate and placebo groups. The chart includes two lines: a solid line for Lisdexamfetamine dimesylate and a dashed line for placebo. The x-axis shows time in days, and the y-axis shows the proportion of subjects with relapse in percentage. Below the graph is a table indicating the number of subjects at risk at various time points 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.