Lisdexamfetamine Dimesylate Capsule
Product Images NDC 47781-567

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Lisdexamfetamine Dimesylate (NDC 47781-567). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Alvogen 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

Figure-1 (Figure 1)

A forest plot chart depicting pharmacokinetic (PK) fold changes with 90% confidence intervals for various special populations, including gender, age groups (65-74 years, >=75 years), and renal impairment levels (mild, moderate, severe, end stage renal disease). The x-axis shows change relative to reference values, and the graph illustrates Cmax and AUC measures for each subgroup.*

FDA Label Image

Figure-2 (Figure 2)

A pharmacokinetic fold change graph comparing Cmax and AUC values for Guanfacine, Venlafaxine, and Omeprazole relative to a reference. The chart shows markers with 90% confidence intervals plotted against a horizontal axis labeled 'Change relative to reference' ranging from 0.0 to 2.0.*

FDA Label Image

Figure-3 (Figure 3)

A pharmacokinetic chart depicting fold change and 90% confidence intervals for Cmax and AUC parameters of various interacting drugs relative to reference. Drugs assessed include Guanfacine, Venlafaxine, CYP1A2 substrate Caffeine, CYP2D6 substrate Dextromethorphan, CYP2C19 substrate Omeprazole, and CYP3A substrate Midazolam. The x-axis shows change relative to reference from 0 to 2.0.*

FDA Label Image

Figure-4 (Figure 4)

A line graph comparing LS Mean SKAMP Deportment Scores over time post-dose (hours) between placebo and lisdexamfetamine dimesylate. The x-axis represents time post-dose from -0.5 to 13 hours, and the y-axis shows LS Mean SKAMP Deportment Scores ranging from 0 to 2. Both treatments have error bars indicating variability.*

FDA Label Image

Figure-5 (Figure 5)

A line graph comparing the proportion of subjects with relapse or treatment failure over time (days after randomization) between lisdexamfetamine dimesylate and placebo groups. The graph shows that subjects receiving lisdexamfetamine dimesylate have a much lower proportion of relapse/failure than those receiving placebo, with proportional differences increasing up to around 45 days.*

FDA Label Image

Figure-6 (Figure 6)

A line graph depicting LS Mean (SE) PERMP Total Scores over time post-dose (hours) comparing lisdexamfetamine dimesylate and placebo. The x-axis represents time from before dosing to 14 hours post-dose, while the y-axis shows PERMP Total Scores. Two lines illustrate the scores for placebo and lisdexamfetamine dimesylate groups with error bars indicating variability.*

FDA Label Image

Figure-7 (Figure 7)

A line graph showing the proportion of subjects with relapse or treatment failure (%) over time (days after randomization) comparing placebo and lisdexamfetamine dimesylate. The placebo group is represented by a dashed line, showing a steadily increasing relapse rate up to about 75% by day 35. The lisdexamfetamine dimesylate group is represented by a solid line, showing a much lower relapse rate remaining below 10% over the same period.*

FDA Label Image

Figure-8 (Figure 8)

A Kaplan-Meier cumulative relapse rate plot comparing lisdexamfetamine dimesylate with placebo over approximately 210 days post-randomization. The graph shows the proportion of subjects with relapse (%) on the y-axis and time in days on the x-axis, with a table of subjects at risk per time interval displayed below the plot.*

FDA Label Image

Label-10mg (Label 10mg)

Label for Lisdexamfetamine Dimesylate capsules 10 mg by Alvogen Inc. The yellow label shows the drug name, strength, and quantity of 100 capsules. It includes storage instructions, pharmacist dispensing guidance, and the NDC number 47781-562-01. The label states the medication is prescription-only and a product of the USA.*

FDA Label Image

Label-20mg (Label 20mg)

Label for lisdexamfetamine dimesylate 20 mg capsules by Alvogen Inc. The label indicates the active ingredient strength, storage instructions, and that the package contains 100 capsules. It advises pharmacists to dispense the Medication Guide to patients and provides the NDC 47781-563-01 along with distributor information.*

FDA Label Image

Label-30mg (Label 30mg)

Lisdexamfetamine Dimesylate Capsules 30 mg label from Alvogen Inc. The label includes the active ingredient strength as 30 mg lisdexamfetamine dimesylate per capsule. It states the package contains 100 capsules and includes storage instructions for controlled room temperature between 20°C to 25°C, with permitted excursions. The label also has an NDC number 47781-564-01 and a barcode, with prescription-only designation.*

FDA Label Image

Label-40mg (Label 40mg)

Label for Lisdexamfetamine Dimesylate Capsules 40 mg by Alvogen Inc. The label states each capsule contains 40 mg lisdexamfetamine dimesylate, equivalent to 23.1 mg lisdexamfetamine. It is an oral prescription drug available in a bottle of 100 capsules. The label includes storage instructions and a notice to dispense the medication guide to patients.*

FDA Label Image

Label-50mg (Label 50mg)

Label for Lisdexamfetamine Dimesylate Capsules 50 mg by Alvogen Inc. The label states each capsule contains 50 mg lisdexamfetamine dimesylate (equivalent to 28.9 mg lisdexamfetamine). It shows the NDC 47781-566-01, package quantity of 100 capsules, and storage instructions to keep at controlled room temperature with specified excursions. The label includes a barcode, distributor address in Morristown, NJ, and advises dispensing the Medication Guide to patients.*

FDA Label Image

Label-60mg (Label 60mg)

Label for Lisdexamfetamine Dimesylate Capsules 60 mg by Alvogen Inc. The label shows the active ingredient amount, product code (NDC 47781-567-01), and storage instructions. It indicates the package contains 100 capsules, is for prescription use only, and includes pharmacist dispensing guidance. Distributed by Alvogen, Inc., Morristown, NJ, USA.*

FDA Label Image

Label-70mg (Label 70mg)

Label for lisdexamfetamine dimesylate capsules 70 mg by Alvogen Inc. The label includes dosage strength, NDC 47781-568-01, and storage instructions to keep at room temperature with permitted excursions. It indicates 100 capsules per container, Rx only, and advises pharmacists to dispense the medication guide separately. The product is distributed by Alvogen, Morristown, NJ, USA.*

FDA Label Image

Structure (Structure)

Chemical structure diagram of lisdexamfetamine dimesylate, showing the molecular arrangement of the active ingredient including the amine groups and dimesylate moieties.*

* 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.