Lisdexamfetamine Dimesylate Capsule
Product Images NDC 0527-4663

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Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Lisdexamfetamine Dimesylate (NDC 0527-4663). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Lannett Company, 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 (Lisdexamfetamine Dimesylate Capsules 1)

Chemical Structure (Lisdexamfetamine Dimesylate Capsules 1)
Chemical structure of Lisdexamfetamine Dimesylate, depicting its molecular components including a phenyl ring, amide linkage, and the dimesylate groups.*
FDA Label Image

10 mg (Lisdexamfetamine Dimesylate Capsules 10)

10 mg (Lisdexamfetamine Dimesylate Capsules 10)
Label for Lisdexamfetamine Dimesylate Capsules 10 mg by Lannett Company, Inc. The label indicates each capsule contains 10 mg of lisdexamfetamine dimesylate. It includes storage instructions, pharmacist dispensing guidance, and the package contains 100 capsules. The label also features a barcode and revision date of 09/22.*
FDA Label Image

20 mg (Lisdexamfetamine Dimesylate Capsules 11)

20 mg (Lisdexamfetamine Dimesylate Capsules 11)
Lisdexamfetamine Dimesylate Capsules 20 mg label for oral use, distributed by Lannett Company, Inc. The label includes storage instructions, dosage information, and a package size of 100 capsules. It also features a barcode and advises dispensing the accompanying medication guide to patients.*
FDA Label Image

30 mg (Lisdexamfetamine Dimesylate Capsules 12)

30 mg (Lisdexamfetamine Dimesylate Capsules 12)
Lisdexamfetamine Dimesylate Capsules 30 mg capsule label from Lannett Company, Inc. The label includes dosage strength, instructions to dispense the medication guide, storage conditions, and a note to keep out of reach of children. It states the package contains 100 capsules, with storage temperature guidelines and barcode information.*
FDA Label Image

40 mg (Lisdexamfetamine Dimesylate Capsules 13)

40 mg (Lisdexamfetamine Dimesylate Capsules 13)
Label for Lisdexamfetamine Dimesylate Capsules 40 mg by Lannett Company, Inc. The label includes dosage information, storage instructions, and directions to dispense the Medication Guide with the prescription. It indicates the package contains 100 capsules and provides the NDC code 0527-4664-37. Printed in black and pink with a barcode on the right side.*
FDA Label Image

50 mg (Lisdexamfetamine Dimesylate Capsules 14)

50 mg (Lisdexamfetamine Dimesylate Capsules 14)
Label for Lisdexamfetamine Dimesylate Capsules 50 mg by Lannett Company, Inc. The label shows active ingredient details, dosage form as capsules, quantity of 100 capsules, and storage instructions including room temperature guidelines. It includes dispensing warnings, a barcode, and a link for medication guides.*
FDA Label Image

60 mg (Lisdexamfetamine Dimesylate Capsules 15)

60 mg (Lisdexamfetamine Dimesylate Capsules 15)
Label for Lisdexamfetamine Dimesylate Capsules, 60 mg strength, oral capsule form, distributed by Lannett Company, Inc. The label includes storage instructions, a quantity of 100 capsules, and a note to dispense the accompanying medication guide to each patient. It features a barcode and the Lannett logo.*
FDA Label Image

70 mg (Lisdexamfetamine Dimesylate Capsules 16)

70 mg (Lisdexamfetamine Dimesylate Capsules 16)
Label for Lisdexamfetamine Dimesylate Capsules 70 mg by Lannett Company, Inc. The label states dosage information, storage conditions, packaging details of 100 capsules, and includes a barcode. It directs pharmacists to dispense a medication guide and provides a website for printed guides.*
FDA Label Image

Figure 1 (Lisdexamfetamine Dimesylate Capsules 2)

Figure 1 (Lisdexamfetamine Dimesylate Capsules 2)
A forest plot chart presenting pharmacokinetic (PK) data showing fold change and 90% confidence intervals (CI) for Cmax and AUC across special populations. The populations include different gender groups, age ranges (65-74 years, ≥75 years), renal impairment levels (mild, moderate, severe), and end stage renal disease, with changes relative to a reference indicated on the horizontal axis.*
FDA Label Image

Figure 2 (Lisdexamfetamine Dimesylate Capsules 3)

Figure 2 (Lisdexamfetamine Dimesylate Capsules 3)
A pharmacokinetic chart illustrating fold changes and 90% confidence intervals for Cmax and AUC parameters influenced by three drugs: Guanfacine, Venlafaxine, and Omeprazole. The x-axis shows change relative to reference values ranging from 0.0 to 2.0, with data points and error bars representing variability.*
FDA Label Image

Figure 3 (Lisdexamfetamine Dimesylate Capsules 4)

Figure 3 (Lisdexamfetamine Dimesylate Capsules 4)
A horizontal forest plot chart depicting fold changes and 90% confidence intervals for various interacting drugs on pharmacokinetic parameters Cmax and AUC. The drugs listed include Guanfacine, Venlafaxine, CYP1A2 substrates like Caffeine, CYP2D6 substrates like Dextromethorphan, CYP2C19 substrates like Omeprazole, and CYP3A substrates like Midazolam. The x-axis indicates the change relative to reference, ranging approximately from 0.0 to 2.0.*
FDA Label Image

Figure 4 (Lisdexamfetamine Dimesylate Capsules 5)

Figure 4 (Lisdexamfetamine Dimesylate Capsules 5)
A line graph comparing LS Mean (SE) SKAMP Deportment Scores over time post-dose (hours) for Lisdexamfetamine Dimesylate Capsules versus Placebo. The x-axis represents time post-dose from -0.5 to 13 hours, and the y-axis represents scores from 0.0 to 2.0. The graph shows two lines with error bars: a solid line for Lisdexamfetamine Dimesylate Capsules and a dashed line for Placebo, illustrating different score trends across time.*
FDA Label Image

Figure 5 (Lisdexamfetamine Dimesylate Capsules 6)

Figure 5 (Lisdexamfetamine Dimesylate Capsules 6)
A line graph displaying the proportion of subjects with relapse or treatment failure over time in days after randomization, comparing SPD489 treatment (solid line) with placebo (dashed line). The vertical axis shows the percentage of affected subjects, while the horizontal axis represents time up to 55 days.*
FDA Label Image

Figure 6 (Lisdexamfetamine Dimesylate Capsules 7)

Figure 6 (Lisdexamfetamine Dimesylate Capsules 7)
A line graph comparing the LS Mean (SE) PERMP Total Scores over time post-dose (hours) between placebo and Lisdexamfetamine Dimesylate capsules. The x-axis shows time post-dose in hours from -0.5 to 14, and the y-axis displays PERMP total scores ranging approximately from 250 to 330. Two lines are plotted: one for placebo (dashed with black circles) and one for Lisdexamfetamine Dimesylate capsules (solid with white squares), with error bars indicating standard error at each time point.*
FDA Label Image

Figure 7 (Lisdexamfetamine Dimesylate Capsules 8)

Figure 7 (Lisdexamfetamine Dimesylate Capsules 8)
A Kaplan-Meier survival curve comparing the proportion of subjects with relapse or treatment failure over time (days after randomization) for Lisdexamfetamine Dimesylate capsules versus placebo. The chart shows a solid line for Lisdexamfetamine Dimesylate and a dashed line for placebo, demonstrating lower relapse rates over time in the Lisdexamfetamine group.*
FDA Label Image

Figure 8 (Lisdexamfetamine Dimesylate Capsules 9)

Figure 8 (Lisdexamfetamine Dimesylate Capsules 9)
A Kaplan-Meier survival curve showing the proportion of subjects with relapse over time in days after randomization, comparing Lisdexamfetamine Dimesylate Capsules and Placebo groups. The graph includes sample sizes of subjects at risk at various time points for both groups, with the placebo group showing a higher relapse rate.*

* 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.