Lisdexamfetamine Dimesylate Capsule
Product Images NDC 60505-4743

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Lisdexamfetamine Dimesylate (NDC 60505-4743). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Apotex Corp., 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

Bottle-label-10mg-100s.jpg (Bottle Label 10mg 100s)

Label for Lisdexamfetamine Dimesylate Capsules 10 mg by Apotex Corp. The label states each capsule contains 10 mg lisdexamfetamine dimesylate (equivalent to 5.8 mg lisdexamfetamine). The package contains 100 capsules. Storage instructions and dispensing warnings are included, along with manufacturer details of Frontida BioPharm, LLC, Philadelphia, PA, and Apotex Corp., Weston, FL. A barcode is present on the right side.*

FDA Label Image

Bottle-label-20mg-100s.jpg (Bottle Label 20mg 100s)

Label for Lisdexamfetamine Dimesylate Capsules 20 mg in a 100 capsule container. Manufactured by Frontida BioPharm, LLC, and labeled for Apotex Corp. The label includes storage instructions, dosage information disclaimer, barcode, and directs pharmacists to dispense with a medication guide.*

FDA Label Image

Bottle-label-30mg-100s.jpg (Bottle Label 30mg 100s)

Packaging label for Lisdexamfetamine Dimesylate Capsules 30 mg by Apotex Corp. The label states the product contains 100 capsules and includes storage instructions, manufacturer and labeler details, and a barcode. It also references dispensing instructions for pharmacists and dosage information.*

FDA Label Image

Bottle-label-40mg-100s.jpg (Bottle Label 40mg 100s)

Label for Lisdexamfetamine Dimesylate Capsules 40 mg, oral capsules supplied in a container of 100 capsules. Manufactured by Fromdita BioPharm, LLC and labeled for Apotex Corp. The label includes storage instructions and a barcode, with bold purple and pink color highlights on the product name and strength.*

FDA Label Image

Bottle-label-50mg-100s.jpg (Bottle Label 50mg 100s)

Lisdexamfetamine Dimesylate Capsules 50 mg oral capsules, packaged in a container of 100 capsules. Label shows the active ingredient with equivalent lisdexamfetamine amount and storage instructions. Manufactured by Frontida BioPharm, LLC, and labeled by Apotex Corp. Includes a barcode and directs pharmacists to dispense with Medication Guide.*

FDA Label Image

Bottle-label-60mg-100s.jpg (Bottle Label 60mg 100s)

Label for Lisdexamfetamine Dimesylate Capsules 60 mg by Apotex Corp. The label includes drug name, strength, dosage form (capsules), storage conditions, pharmacist dispensing instructions, NDC 60505-4744-1, manufacturer details for Frontida BioPharm, LLC and Apotex Corp., and a barcode.*

FDA Label Image

Bottle-label-70mg-100s.jpg (Bottle Label 70mg 100s)

Label for Lisdexamfetamine Dimesylate Capsules 70 mg by Apotex Corp. The label shows the product name with strength, dosage form, quantity of 100 capsules, the NDC number 60505-4745-1, and manufacturing details from Frontida BioPharm, LLC in Philadelphia. Storage instructions and dispensing advice are included.*

FDA Label Image

Figure-1.jpg (Figure 1)

A forest plot chart showing pharmacokinetic (PK) parameters Cmax and AUC with fold change and 90% confidence intervals for different special populations including gender, age groups (65-74 years, >=75 years), and varying levels of renal impairment from mild to end stage renal disease. The x-axis represents change relative to reference from 0.0 to 2.5.*

FDA Label Image

Figure-2.jpg (Figure 2)

A forest plot chart showing pharmacokinetic fold changes and 90% confidence intervals (CI) for three drugs (Guanfacine, Venlafaxine, Omeprazole), each with measures of Cmax and AUC. The x-axis represents change relative to reference from 0.0 to 2.0. Each data point is represented by an orange diamond with horizontal error bars indicating the confidence intervals.*

FDA Label Image

Figure-3.jpg (Figure 3)

A pharmacokinetic chart illustrating the fold change and 90% confidence intervals of various interacting drugs relative to a reference. It includes drugs such as Guanfacine, Venlafaxine, and substrates of CYP1A2, CYP2D6, CYP2C19, and CYP3A enzymes, measuring their Cmax and AUC values with data points plotted along a horizontal axis indicating change relative to reference from 0.0 to 2.0.*

FDA Label Image

Figure-4.jpg (Figure 4)

Line graph showing LS Mean (SE) SKAMP Deportment Scores over time post-dose (hours) comparing placebo and Lisdexamfetamine Dimesylate Capsules. The graph depicts changes in scores from approximately -0.5 to 13 hours after dosing with separate lines for placebo and active drug, including error bars for standard error.*

FDA Label Image

Figure-5.jpg (Figure 5)

A line graph comparing the proportion of subjects with relapse or treatment failure over time (days after randomization) between placebo (dashed line) and Lisdexamfetamine Dimesylate Capsules (solid line). The graph shows lower relapse rates for Lisdexamfetamine Dimesylate Capsules compared to placebo across the time period up to 50 days.*

FDA Label Image

Figure-6.jpg (Figure 6)

A line graph depicting LS Mean (SE) PERMP Total Scores over time post-dose (hours) comparing Lisdexamfetamine Dimesylate Capsules versus placebo. The x-axis shows time from -0.5 to 14 hours post-dose, while the y-axis measures score values from 250 to 330. Solid line represents Lisdexamfetamine Dimesylate, with generally higher scores across the time points compared to the dashed line for placebo.*

FDA Label Image

Figure-7.jpg (Figure 7)

A line graph comparing the proportion of subjects with relapse or treatment failure over time between placebo and Lisdexamfetamine Dimesylate capsules. The x-axis represents time in days after randomization, and the y-axis shows the percentage of subjects with relapse or treatment failure. The placebo group shows a higher and increasing proportion of treatment failure compared to the Lisdexamfetamine Dimesylate capsules group, which remains low and relatively stable.*

FDA Label Image

Figure-8.jpg (Figure 8)

A line graph showing the proportion of subjects with relapse (%) over time in days after randomization for Lisdexamfetamine Dimesylate Capsules versus placebo. The graph includes two lines: a solid line for Lisdexamfetamine Dimesylate Capsules and a dashed line for placebo. The x-axis represents time in days, and the y-axis shows the proportion of subjects with relapse. Below the graph, a table lists subjects at risk at various time points for both treatment groups.*

FDA Label Image

Structure.jpg (Structure)

Chemical structure of lisdexamfetamine dimesylate showing the molecular arrangement of atoms, including amine groups, carbonyl group, and the dimesylate moiety represented as a separate bracketed structure.*

* 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.