Lisdexamfetamine Dimesylate Capsule
Product Images NDC 70010-207

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Lisdexamfetamine Dimesylate (NDC 70010-207). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Granules Pharmaceuticals 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

Lisdexamfe-10mg-label (Lisdexamfe 10mg Label)

Lisdexamfetamine Dimesylate Capsules 10 mg label showing 100 capsules per container. The label includes dosage information, storage instructions, manufacturer details for Granules Pharmaceuticals Inc., and a barcode. Packaging notes to dispense the medication guide separately to each patient are also visible.*

FDA Label Image

Lisdexamfe-20mg-label (Lisdexamfe 20mg Label)

Label for Lisdexamfetamine Dimesylate Capsules 20 mg by Granules Pharmaceuticals Inc. The label includes dosage strength, quantity of 100 capsules, storage instructions, pharmacist dispensing instructions, and a barcode. The product is indicated as prescription only with NDC 70010-207-01.*

FDA Label Image

Lisdexamfe-30mg-label (Lisdexamfe 30mg Label)

Label for Lisdexamfetamine Dimesylate Capsules 30 mg, an oral prescription capsule by Granules Pharmaceuticals Inc. The label includes storage instructions, dosage reference, quantity of 100 capsules, and a barcode. It also highlights dispensing the Medication Guide to patients and provides a link to printed guides.*

FDA Label Image

Lisdexamfe-40mg-label (Lisdexamfe 40mg Label)

Label for Lisdexamfetamine Dimesylate Capsules 40 mg by Granules Pharmaceuticals Inc. The label indicates a package containing 100 oral capsules, with storage instructions and a note to dispense the medication guide to patients. The label includes the NDC code 70010-209-01 and a barcode.*

FDA Label Image

Lisdexamfe-50mg-label (Lisdexamfe 50mg Label)

Label for Lisdexamfetamine Dimesylate Capsules 50 mg by Granules Pharmaceuticals Inc. The label includes dosage strength, quantity of 100 capsules, storage instructions, and a barcode. It indicates prescription-only status and references a medication guide and package insert for dosage information.*

FDA Label Image

Lisdexamfe-60mg-label (Lisdexamfe 60mg Label)

Label for Lisdexamfetamine Dimesylate Capsules 60 mg, oral capsules manufactured by Granules Pharmaceuticals Inc. The label indicates a package size of 100 capsules, prescription use only, and storage instructions between 20°C to 25°C with permitted excursions. It includes directions for pharmacists to dispense the Medication Guide separately and provides a web link for Medication Guides. The label shows the NDC number 70010-211-01 and a barcode.*

FDA Label Image

Lisdexamfe-70mg-label (Lisdexamfe 70mg Label)

Label for Lisdexamfetamine Dimesylate Capsules 70 mg by Granules Pharmaceuticals Inc. The label indicates NDC 70010-212-01, is Rx only, and contains 100 capsules. It includes storage instructions, dispensing guidance, and a barcode. The label specifies each capsule contains lisdexamfetamine dimesylate 70 mg equivalent to 40.5 mg lisdexamfetamine.*

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Lisdexamfe-fig1 (Lisdexamfe Fig1)

A forest plot chart illustrating fold change and 90% confidence intervals for pharmacokinetic parameters Cmax and AUC of Lisdexamfetamine Dimesylate across special populations: gender (male/female), age groups (65-74 years, 75+ years), and varying degrees of renal impairment including mild, moderate, severe, and end stage renal disease. The x-axis shows change relative to reference from 0.0 to 2.5.*

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Lisdexamfe-fig2 (Lisdexamfe Fig2)

A forest plot chart showing pharmacokinetic changes (Cmax and AUC) with 90% confidence intervals for Guanfacine, Venlafaxine, and Omeprazole. The x-axis represents fold change relative to reference ranging from 0.0 to 2.0, with markers indicating Cmax and AUC values for each drug comparison.*

FDA Label Image

Lisdexamfe-fig3 (Lisdexamfe Fig3)

A forest plot chart showing the pharmacokinetic fold change and 90% confidence intervals for various interacting drugs with Lisdexamfetamine Dimesylate. It includes drugs like Guanfacine, Venlafaxine, and substrates of CYP1A2, CYP2D6, CYP2C19, and CYP3A enzymes, with data points for Cmax and AUC, plotted against a reference change value starting at 1.0 on the x-axis.*

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Lisdexamfe-fig4 (Lisdexamfe Fig4)

A line graph showing LS Mean (SE) SKAMP Deportment Scores over time post-dose (hours) comparing Lisdexamfetamine Dimesylate Capsules to placebo. The graph depicts scores on the y-axis from 0.0 to 2.0 and time on the x-axis from -0.5 to 13 hours, with separate lines for placebo (dashed) and Lisdexamfetamine Dimesylate Capsules (solid), including error bars for each data point.*

FDA Label Image

Lisdexamfe-fig5 (Lisdexamfe Fig5)

A line graph comparing the proportion of subjects with relapse or treatment failure over time in days after randomization for Lisdexamfetamine Dimesylate Capsules versus placebo. The y-axis shows the proportion (%) of subjects with relapse/treatment failure, and the x-axis shows time in days up to 55. The graph includes a solid line for Lisdexamfetamine Dimesylate Capsules and a dashed line for placebo.*

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Lisdexamfe-fig6 (Lisdexamfe Fig6)

A line graph comparing LS Mean (SE) PERMP total scores over time post-dose (hours) between Placebo and Lisdexamfetamine Dimesylate Capsules. The horizontal axis represents time from about -0.5 to 14 hours post-dose, while the vertical axis shows scores from 250 to 330. Lisdexamfetamine Dimesylate Capsules show a higher increase in scores over time compared to Placebo, with error bars indicating variability at each time point.*

FDA Label Image

Lisdexamfe-fig7 (Lisdexamfe Fig7)

A Kaplan-Meier survival curve comparing the proportion of subjects with relapse or treatment failure over time (days after randomization) between placebo and lisdexamfetamine dimesylate capsules. The graph shows a higher relapse rate in the placebo group versus a lower rate in the lisdexamfetamine dimesylate capsules group across a period of approximately 35 days.*

FDA Label Image

Lisdexamfe-fig8 (Lisdexamfe Fig8)

A line graph comparing the proportion of subjects with relapse (%) over time (days after randomization) between Lisdexamfetamine Dimesylate Capsules and placebo groups. The graph shows relapse rates decreasing over about 209 days, with the placebo group having higher relapse proportions than the Lisdexamfetamine Dimesylate Capsules group. Below the graph, a table lists the number of subjects at risk at various time points for each group.*

FDA Label Image

Lisdexamfe-structure (Lisdexamfe Structure)

Chemical structure of lisdexamfetamine dimesylate, showing the molecular formula with a phenyl ring, amide group, and two mesylate (methanesulfonate) counterions.*

* 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.