Lisdexamfetamine Dimesylate Capsule
Product Images NDC 57664-047

Product Visual Gallery

This gallery contains 29 technical images submitted to the FDA as part of the official labeling for Lisdexamfetamine Dimesylate (NDC 57664-047). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sun Pharmaceutical Industries, 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.

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Table 1 (Table 1)

A data table comparing the incidence percentages of various side effects between Lisdexamfetamine Dimesylate (n=218) and Placebo (n=72) groups. Side effects listed include decreased appetite, insomnia, abdominal pain, irritability, vomiting, weight decrease, nausea, dry mouth, dizziness, affect lability, rash, pyrexia, somnolence, tic, and anorexia, with higher rates generally observed in the Lisdexamfetamine Dimesylate group.*

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Table 2 (Table 2)

Data table presenting the percentages of selected adverse events reported in clinical study groups for Lisdexamfetamine Dimesylate (n=233) and placebo (n=77), including decreased appetite, insomnia, weight decreased, dry mouth, palpitations, anorexia, and tremor.*

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Table 3 (Table 3)

A data table comparing the incidence percentages of various side effects between subjects taking Lisdexamfetamine Dimesylate (n=358) and a placebo group (n=62). Side effects listed include decreased appetite, insomnia, dry mouth, diarrhea, nausea, anxiety, anorexia, feeling jittery, agitation, increased blood pressure, hyperhidrosis, restlessness, decreased weight, dyspnea, increased heart rate, tremor, and palpitations.*

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Table 4 (Table 4)

A data table comparing the incidence of various side effects between LISDEXAMFETAMINE DIMESYLATE (N=373) and placebo (N=372) groups. It lists side effects such as dry mouth, insomnia, decreased appetite, increased heart rate, and others, with corresponding percentages for each group.*

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Table 5 (Table 5)

Text table detailing clinical impact and interventions for lisdexamfetamine dimesylate interactions with various drug classes including MAOI, serotonergic drugs, CYP2D6 inhibitors, alkalinizing agents, acidifying agents, and tricyclic antidepressants. It summarizes risk of serotonin syndrome, effects on amphetamine metabolism, and dosing considerations.*

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Structure (Lisdexamfetamine 01)

Chemical structure of lisdexamfetamine dimesylate showing the molecular arrangement of its components, including the dimesylate moiety.*

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Figure 1 (Figure 1)

A fold change and 90% confidence interval chart comparing pharmacokinetic parameters (Cmax and AUC) of lisdexamfetamine dimesylate across various special populations. Groups include gender, age categories (65-74 years, >=75 years), and renal impairment levels (mild, moderate, severe, end stage renal disease). The x-axis shows change relative to reference.*

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Figure 2 (Figure 2)

A forest plot showing fold change and 90% confidence intervals for pharmacokinetic parameters Cmax and AUC of LISDEXAMFETAMINE DIMESYLATE when co-administered with Guanfacine, Venlafaxine, and Omeprazole. The horizontal axis represents change relative to reference, ranging from 0.0 to 2.0, with fold change values and confidence intervals displayed for each drug interaction.*

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Figure 3 (Figure 3)

A forest plot illustrating fold change and 90% confidence intervals for pharmacokinetic parameters Cmax and AUC of various interacting drugs relative to a reference. Interacting drugs include Guanfacine, Venlafaxine, caffeine (CYP1A2 substrate), Dextromethorphan (CYP2D6 substrate), Omeprazole (CYP2C19 substrate), and Midazolam (CYP3A substrate). The x-axis represents change relative to reference from 0.0 to 2.0.*

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Table 6 (Table 6)

A clinical study data table presenting multiple study numbers and age ranges, primary endpoints, treatment groups with various doses of Lisdexamfetamine Dimesylate capsules ranging mostly from 30 mg to 70 mg per day, baseline scores, changes from baseline, and placebo-subtracted differences with 95% confidence intervals. The table includes data from studies involving children, adolescents, and adults for ADHD-related endpoints and other measures.*

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Figure 4 (Lisdexamfetamine 05)

A line graph comparing the LS mean SKAMP Deportment Scores over time post-dose (hours) between Lisdexamfetamine Dimesylate and placebo. The x-axis represents time in hours from -0.5 to 13, and the y-axis shows the LS mean SKAMP Deportment Scores ranging from 0.0 to 2.0. The graph includes error bars indicating standard error of the mean (SEM) for each data point.*

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Figure 5 (Lisdexamfetamine 06)

A line graph comparing the proportion of subjects with relapse or treatment failure over time between Lisdexamfetamine Dimesylate and placebo groups. The X-axis shows time in days after randomization, and the Y-axis shows the percentage of subjects with relapse or treatment failure. The Lisdexamfetamine Dimesylate group has consistently lower relapse rates compared to placebo over the 50-day period.*

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Figure 6 (Lisdexamfetamine 07)

A line graph comparing LS Mean (SE) PERMP Total Scores over time post-dose (hours) between placebo and Lisdexamfetamine Dimesylate. The graph shows scores increasing over time for both groups, with Lisdexamfetamine Dimesylate consistently scoring higher than placebo from about 2 to 14 hours post-dose, including error bars indicating variability at each time point.*

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Figure 7 (Lisdexamfetamine 08)

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 days up to 40, and the y-axis shows the percentage of subjects with relapse or treatment failure, illustrating lower proportions for Lisdexamfetamine Dimesylate than placebo across the time course.*

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Table 7 (Table 7)

A data table comparing the primary efficacy measure of binge days per week at week 12 between treatment groups and placebo in two studies (Study 11 and Study 12). It includes mean baseline scores with standard deviations, least squares mean change from baseline with standard errors, and placebo-subtracted differences with 95% confidence intervals for Lisdexamfetamine Dimesylate (50 or 70 mg/day).*

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Figure 8 (Lisdexamfetamine 09)

A line graph showing the proportion of subjects with relapse over time (days after randomization) comparing Lisdexamfetamine Dimesylate and placebo groups. The graph includes numbers of subjects at risk for both groups at various time points along the x-axis.*

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Pdp Caps-10mg (Lisdexamfetamine 10)

Label for LISDEXAMFETAMINE DIMESYLATE Capsules 10 mg by Sun Pharmaceutical Industries, Inc. The label includes dosing instructions, pharmacist dispensing guidance, a barcode, and a statement indicating 100 capsules per container for prescription use only.*

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Pdp Caps (20mg)

Label for Lisdexamfetamine Dimesylate Capsules, 20 mg strength, manufactured by Sun Pharmaceutical Industries, Inc. The label specifies the product as a 100-capsule bottle with a prescription only indication. It includes dosing and storage information along with barcode and NDC 57664-047-88.*

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Pdp Caps-30mg (Lisdexamfetamine 12)

Lisdexamfetamine Dimesylate Capsules 30 mg oral dosage form packaging label from Sun Pharmaceutical Industries, Inc. The label indicates a prescription product containing 100 capsules. It includes directions to dispense with the Medication Guide and displays the NDC 57664-048-88. Additional details cover ingredient content.*

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Pdp Caps (40mg)

Lisdexamfetamine Dimesylate Capsules 40 mg label from Sun Pharmaceutical Industries, Inc. The label indicates the strength as 40 mg per capsule, includes a barcode, and specifies that the package contains 100 capsules. It also includes a pharmacist dispensing note and storage instructions.*

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Pdp Caps (50mg)

Label for Lisdexamfetamine Dimesylate Capsules 50 mg by Sun Pharmaceutical Industries, Inc. The label includes the dosage strength, a quantity indication of 100 capsules, and a pharmacist advisory to dispense with a medication guide. It features a barcode, NDC 57664-050-88, and storage instructions.*

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Pdp Caps (60mg)

Label for Lisdexamfetamine Dimesylate Capsules 60 mg by Sun Pharmaceutical Industries, Inc. The label indicates the product contains 100 capsules for oral use. It includes directions for pharmacists to dispense with a Medication Guide, and lists the National Drug Code (NDC) 57664-051-88 along with manufacturer information in Grand Island, NY.*

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Pdp Caps-70mg (Lisdexamfetamine 16)

Label for Lisdexamfetamine Dimesylate Capsules 70 mg, oral dosage form, manufactured by Sun Pharmaceutical Industries, Inc. The label indicates prescription use only, with a quantity of 100 capsules. Includes dispensing instructions for pharmacists and various regulatory and storage information. Barcodes are shown on the right side of the label.*

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Pdp-chew-10mg (Lisdexamfetamine 17)

Lisdexamfetamine Dimesylate Chewable Tablets 10 mg packaging label from Sun Pharmaceutical Industries, Inc. The label includes dosage strength (10 mg), quantity (100 chewable tablets), pharmacist dispensing instructions, and storage conditions. The product is indicated as prescription only with NDC 57664-083-88.*

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Pdp-chew-20mg (Lisdexamfetamine 18)

Label for Lisdexamfetamine Dimesylate Chewable Tablets 20 mg, supplied in a package of 100 chewable tablets. The label includes dispensing instructions for pharmacists, storage conditions, and manufacturer information for Sun Pharmaceutical Industries, Inc. It also displays a barcode and the NDC number 57664-084-88.*

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Pdp-chew-30mg (Lisdexamfetamine 19)

Label for Lisdexamfetamine Dimesylate Chewable Tablets 30 mg by Sun Pharmaceutical Industries, Inc. The label includes dosage form as chewable tablets, quantity of 100 tablets, and pharmacist dispensing instructions. It features the orange and white Sun Pharma logo and provides storage instructions, usage warnings, and the product's NDC 57664-085-88.*

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Pdp-chew-40mg (Lisdexamfetamine 20)

Lisdexamfetamine Dimesylate Chewable Tablets 40 mg label showing the medication name, strength, and chewable tablet form. The label includes dispensing instructions, package quantity of 100 chewable tablets, and the labeler Sun Pharmaceutical Industries, Inc. Manufacturer and storage directions are also visible along with the NDC number 57664-086-88.*

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Pdp-chew-50mg (Lisdexamfetamine 21)

Label for Lisdexamfetamine Dimesylate Chewable Tablets, 50 mg strength. The product is prescription-only with 100 chewable tablets per container. Labeler is Sun Pharmaceutical Industries, Inc. Instructions advise chewing tablets completely before swallowing and dispensing with a medication guide.*

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Pdp-chew-60mg (Lisdexamfetamine 22)

Label for Lisdexamfetamine Dimesylate Chewable Tablets, 60 mg strength. The label shows the dosage form as chewable tablets, quantity of 100 tablets per container, and includes the NDC 67664-088-88. The product is manufactured by Sun Pharmaceutical Industries, Inc. The label provides handling and storage instructions and cautions against swallowing tablets whole. A barcode is present on the right side of the label.*

* 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.