Lisdexamfetamine Dimesylate Capsule
Product Images NDC 0527-4667

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Lisdexamfetamine Dimesylate (NDC 0527-4667). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Lannett Company, 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 Capsules Usp 1)

Chemical structure diagram of Lisdexamfetamine Dimesylate, showing the molecular arrangement of atoms and bonds in the active ingredient.*

FDA Label Image

Figure1 (Lisdexamfetamine Dimesylate Capsules Usp 2)

A forest plot chart titled "Fold Change and 90% CI" showing pharmacokinetic parameters Cmax and AUC for Lisdexamfetamine Dimesylate across special populations including gender, age groups (65-74 years, ≥75 years), and varying degrees of renal impairment (mild, moderate, severe, end-stage). The horizontal axis measures change relative to reference, ranging from 0.0 to 2.5, with data points and confidence intervals for each category plotted accordingly.*

FDA Label Image

Figure 2 (Lisdexamfetamine Dimesylate Capsules Usp 3)

A forest plot chart titled 'Fold Change and 90% CI' showing pharmacokinetic changes (Cmax and AUC) due to the drugs guanfacine, venlafaxine, and omeprazole. The horizontal axis represents change relative to reference from 0.0 to 2.0. Data points with confidence intervals are displayed for each drug and PK parameter, visually comparing fold changes.*

FDA Label Image

Figure 3 (Lisdexamfetamine Dimesylate Capsules Usp 4)

A horizontal forest plot chart showing fold changes and 90% confidence intervals in pharmacokinetic parameters (Cmax and AUC) of various interacting drugs relative to a reference. The drugs listed include Guanfacine, Venlafaxine, caffeine, Dextromethorphan, Omeprazole, and Midazolam, with fold change values and confidence intervals indicated by orange diamonds and bars on a scale from 0 to 2.*

FDA Label Image

Figure 4 (Lisdexamfetamine Dimesylate Capsules Usp 5)

A line graph comparing SKAMP Deportment Scores over time post-dose between Lisdexamfetamine Dimesylate Capsules and placebo. The x-axis shows time in hours post-dose from -0.5 to 13, and the y-axis shows least squares mean (SE) scores from 0.0 to 2.0. The graph includes error bars and demonstrates differing score trends for the two groups across the time points.*

FDA Label Image

Figure 5 (Lisdexamfetamine Dimesylate Capsules Usp 6)

A line chart comparing the proportion of subjects with relapse or treatment failure (%) over time (days after randomization) between SPD489 and placebo groups. The solid line represents SPD489, showing a lower relapse rate over time, while the dashed line represents the placebo group with a higher proportion of relapse or treatment failure.*

FDA Label Image

Figure 6 (Lisdexamfetamine Dimesylate Capsules Usp 7)

A line graph comparing LS Mean (SE) PERMP Total Scores over time post-dose (hours) between placebo and Lisdexamfetamine Dimesylate Capsules. The x-axis represents time in hours from -0.5 to 14, and the y-axis shows score values ranging from 250 to 330. The graph displays two lines with error bars: a dashed line for placebo and a solid line for Lisdexamfetamine Dimesylate Capsules, indicating higher scores for the latter across the time points.*

FDA Label Image

Figure 7 (Lisdexamfetamine Dimesylate Capsules Usp 8)

A line graph comparing the proportion of subjects with relapse or treatment failure over time between Lisdexamfetamine Dimesylate capsules and placebo. The X-axis shows time in days after randomization, and the Y-axis shows the proportion in percentage. The Lisdexamfetamine Dimesylate group shows significantly lower relapse or treatment failure rates across the time span compared to the placebo group, with two distinct line patterns indicated in the legend.*

FDA Label Image

Figure 8 (Lisdexamfetamine Dimesylate Capsules Usp 9)

A line graph comparing the proportion of subjects with relapse over time between Lisdexamfetamine Dimesylate capsules and placebo groups. The x-axis represents time in days after randomization, and the y-axis shows the proportion of subjects relapsed in percentage. The Lisdexamfetamine group shows a low relapse rate, while the placebo group's relapse rate increases over time.*

FDA Label Image

10 mg (Lisdexamfetamine Dimesylate Capsules Usp 10)

Label for Lisdexamfetamine Dimesylate Capsules 10 mg by Lannett Company, LLC. The label includes dosage strength, storage instructions, pharmacist dispensing guidance, a barcode, quantity of 100 capsules, and revision date 09/22. It cautions to keep medication out of children's reach and refers to package insert for dosage information.*

FDA Label Image

20 mg (Lisdexamfetamine Dimesylate Capsules Usp 11)

Label for Lisdexamfetamine Dimesylate Capsules 20 mg by Lannett Company, LLC. The label shows the dosage strength (20 mg), quantity (100 capsules), and includes storage instructions and a notice to keep medication out of reach of children. It also provides a website for the Medication Guide and states 'Rx Only.' A barcode and NDC number are visible on the right side.*

FDA Label Image

30 mg (Lisdexamfetamine Dimesylate Capsules Usp 12)

Label for Lisdexamfetamine Dimesylate Capsules 30 mg, oral capsule form by Lannett Company, LLC. The label includes dosage strength, storage instructions, medication guide reference, count of 100 capsules, and manufacturer details with barcode and regulatory information.*

FDA Label Image

40 mg (Lisdexamfetamine Dimesylate Capsules Usp 13)

Label for Lisdexamfetamine Dimesylate Capsules 40 mg by Lannett Company, LLC. The label includes dosage strength, pharmacy dispensing instructions, storage conditions, and a 100-capsule package size. It also provides a URL for the medication guide and cautions to keep the medication out of reach of children.*

FDA Label Image

50 mg (Lisdexamfetamine Dimesylate Capsules Usp 14)

Label for Lisdexamfetamine Dimesylate Capsules 50 mg by Lannett Company, LLC. The label includes dosage strength, NDC 0527-4665-37, storage instructions, and a notice to dispense the Medication Guide. The package contains 100 oral capsules and highlights child-resistant container requirements.*

FDA Label Image

60 mg (Lisdexamfetamine Dimesylate Capsules Usp 15)

Lisdexamfetamine Dimesylate Capsules 60 mg label from Lannett Company, LLC. The label includes storage instructions at 20-25°C, a note to dispense the accompanying Medication Guide, and states the package contains 100 capsules. It also features the NDC 0527-4666-37 and a barcode.*

FDA Label Image

70 mg (Lisdexamfetamine Dimesylate Capsules Usp 16)

Label for Lisdexamfetamine Dimesylate Capsules 70 mg from Lannett Company, LLC. The label includes dosage strength, storage instructions, pharmacist guidance to dispense the Medication Guide, and package quantity of 100 capsules. A barcode and distributor address in Philadelphia, PA, are visible. The label emphasizes child-resistant packaging and keeping medication out of reach of children.*

* 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.