Lisdexamfetamine Dimesylate Capsule
Product Images NDC 42291-041

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Lisdexamfetamine Dimesylate (NDC 42291-041). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Avkare, 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

1 (036 90)

Lisdexamfetamine Dimesylate Capsules 20 mg label showing the product name, dosage strength, and capsule count of 90. The label includes storage instructions, manufacturer information for AvKARE, NDC 42291-036-90, and a barcode with a QR code. It states the product is Rx only and provides brief pharmacist dispensing instructions.*

FDA Label Image

1 (037 90)

Packaging label for Lisdexamfetamine Dimesylate Capsules, 30 mg strength, manufactured by AvKARE. The label shows the product name, dosage strength in a red box, and container size of 90 capsules. Additional information includes storage instructions, an Rx only designation, and manufacturer details. The label also features a barcode and a QR code.*

FDA Label Image

1 (038 90)

Lisdexamfetamine Dimesylate Capsules 40 mg label from AvKARE featuring product name, strength, and quantity of 90 capsules. Instructions for pharmacists to dispense the accompanying Medication Guide are included, along with storage conditions, active ingredient amount per capsule, and manufacturer details. The label also has barcodes and a QR code.*

FDA Label Image

1 (039 90)

Label for Lisdexamfetamine Dimesylate Capsules 50 mg by AvKARE. The package contains 90 capsules. The label includes dosage information, storage instructions, and a QR code. It states 'Rx only' and provides the National Drug Code (NDC) 42291-039-90.*

FDA Label Image

1 (040 90)

Lisdexamfetamine Dimesylate Capsules 60 mg label by AvKARE. The label specifies the product as prescription only with a quantity of 90 capsules. It includes dosage instructions to see the package insert and storage information (20° to 25°C, USP controlled room temperature). There is a QR code and barcode present on the label.*

FDA Label Image

1 (041 90)

Lisdexamfetamine Dimesylate Capsules 70 mg capsule label by AvKARE. The label indicates prescription use only and contains 90 capsules. Instructions for storage and packaging insert reference are included along with a barcode and QR code. The capsule image shows a red and blue capsule.*

FDA Label Image

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

Chemical structure of lisdexamfetamine dimesylate, showing the molecular arrangement of the lisdexamfetamine moiety and two mesylate (methylsulfonic acid) groups.*

FDA Label Image

Figure 1 (Lisdexamfetamine Dimesylate Capsules 2)

A forest plot chart showing fold change and 90% confidence intervals of pharmacokinetic parameters Cmax and AUC for lisdexamfetamine dimesylate across special populations, including gender (male/female), age groups (65-74 years and 75+ years), and levels of renal impairment (mild, moderate, severe, end stage renal disease). The x-axis represents change relative to reference values.*

FDA Label Image

2 (Lisdexamfetamine Dimesylate Capsules 3)

A chart depicting pharmacokinetic changes showing fold change and 90% confidence intervals for Cmax and AUC of three drugs—Guanfacine, Venlafaxine, and Omeprazole—relative to a reference value, plotted on a horizontal axis from 0.0 to 2.0.*

FDA Label Image

3 (Lisdexamfetamine Dimesylate Capsules 4)

A forest plot chart illustrating the fold change and 90% confidence intervals (CI) for various pharmacokinetic (PK) parameters, including Cmax and AUC for different interacting drugs and CYP substrates such as Guanfacine, Venlafaxine, Caffeine, Dextromethorphan, Omeprazole, and 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 the mean SKAMP deportment scores over time post-dose for Lisdexamfetamine dimesylate versus placebo. The x-axis represents time in hours post-dose, and the y-axis shows the LS mean SKAMP deportment scores, with error bars indicating standard error of the mean (SEM). The graph illustrates changes over approximately 13 hours.*

FDA Label Image

Figure 5 (Lisdexamfetamine Dimesylate Capsules 6)

A Kaplan-Meier curve comparing the proportion of subjects with relapse or treatment failure over time (days after randomization) for Lisdexamfetamine dimesylate versus placebo. The graph shows a lower relapse rate for Lisdexamfetamine dimesylate compared to placebo over a period of approximately 50 days.*

FDA Label Image

6 (Lisdexamfetamine Dimesylate Capsules 7)

A line graph comparing LS mean PERMP total scores over time post-dose (hours) for placebo versus lisdexamfetamine dimesylate. The x-axis represents time from -0.5 to 14 hours post-dose, and the y-axis shows LS mean scores from approximately 250 to 330, with error bars indicating variability. Lisdexamfetamine shows higher scores than placebo across the measured times.*

FDA Label Image

7 (Lisdexamfetamine Dimesylate Capsules 8)

A line graph comparing the proportion of subjects with relapse or treatment failure over time (days after randomization) between placebo and Lisdexamfetamine dimesylate groups. The x-axis represents time in days, and the y-axis shows the percentage of subjects experiencing relapse or treatment failure. The placebo group shows a rising trend reaching about 75%, while the Lisdexamfetamine dimesylate group remains near 10% throughout the period up to 35 days.*

FDA Label Image

Figure 8 (Lisdexamfetamine Dimesylate Capsules 9)

A line graph showing the proportion of subjects with relapse (%) over time (days after randomization) comparing lisdexamfetamine dimesylate and placebo. The graph indicates a lower relapse rate for lisdexamfetamine dimesylate compared to placebo throughout the study period of up to 209 days, with subject counts at risk noted below the x-axis 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.