Lisdexamfetamine Dimesylate Capsule
Product Images NDC 0054-0372

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Lisdexamfetamine Dimesylate (NDC 0054-0372). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Hikma Pharmaceuticals Usa 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

Lisdexamfetamine Pan Black.jpg (Image 01)

Chemical structure of lisdexamfetamine dimesylate showing the arrangement of atoms including phenyl, amide, amine groups, and two mesylate moieties.*

FDA Label Image

Figure-1.jpg (Image 02)

A pharmacokinetic fold change and 90% confidence interval chart showing the Cmax and AUC variables for special populations including gender, age (65-74 years, >=75 years), and renal impairment (mild, moderate, severe, end stage renal disease). The x-axis represents change relative to reference, ranging from 0.0 to 2.5, with plotted diamond markers and error bars for each group and pharmacokinetic measure.*

FDA Label Image

Figure-5.jpg (Image 03)

A line graph comparing the proportion of subjects with relapse or treatment failure over time between placebo and Lisdexamfetamine Dimesylate groups. The placebo group data is shown with a dashed line, and the Lisdexamfetamine Dimesylate group data is shown with a solid line. The x-axis represents time in days after randomization, and the y-axis shows the proportion of subjects with relapse or treatment failure as a percentage.*

FDA Label Image

20mg-100tabs.jpg (Image 04)

Lisdexamfetamine Dimesylate Capsules 20 mg label from Hikma Pharmaceuticals USA Inc. The label includes the active ingredient strength, package count of 100 capsules, storage instructions, and a barcode. It indicates the medication is prescription only (Rx) and advises seeing the package insert for dosage information.*

FDA Label Image

30mg-100tabs.jpg (Image 05)

Label for Lisdexamfetamine Dimesylate Capsules, 30 mg strength, distributed by Hikma Pharmaceuticals USA Inc. The label includes dosage and storage instructions, a barcode, the NDC number 0054-0371-25, and a note that medication guide should be dispensed to patients. The label highlights the 30 mg dosage in a green box.*

FDA Label Image

Figure 4.jpg (Image 06)

A line graph showing SKAMP deportment scores (LS Mean with SE) over time post-dose (hours) comparing lisdexamfetamine dimesylate and placebo. The graph plots results from just before dosing up to 13 hours post-dose, illustrating lower scores for lisdexamfetamine dimesylate compared to placebo throughout most of the period.*

FDA Label Image

Image-6.jpg (Image 07)

A line graph comparing the LS Mean (SE) PERMP Total Scores over time post-dose (hours) between Placebo and Lisdexamfetamine Dimesylate. The x-axis shows time from -0.5 to 14 hours, and the y-axis shows scores ranging approximately from 250 to 330. Two lines represent Placebo (dashed line with circles) and Lisdexamfetamine Dimesylate (solid line with squares), illustrating score changes over time with error bars for variability.*

FDA Label Image

Image-7.jpg (Image 08)

A Kaplan-Meier curve showing the proportion of subjects with relapse or treatment failure over time (days after randomization) comparing Lisdexamfetamine Dimesylate with placebo. The graph indicates a lower proportion of relapse in the Lisdexamfetamine Dimesylate group compared to placebo across the 40-day period.*

FDA Label Image

40mg-100tabs.jpg (Image 09)

Label for Lisdexamfetamine Dimesylate Capsules 40 mg by Hikma Pharmaceuticals USA Inc. The label includes the product name, strength, dosage form, NDC number 0054-0372-25, and packaging information for 100 capsules. Storage and dispensing instructions are provided along with a barcode and the Hikma logo.*

FDA Label Image

50mg-100tabs.jpg (Image 10)

Packaging label of Lisdexamfetamine Dimesylate 50 mg capsules by Hikma Pharmaceuticals USA Inc. The label indicates a count of 100 capsules with storage instructions, dispensing guidance, and a barcode. The dosage strength is prominently displayed in purple on a yellow and white background.*

FDA Label Image

60mg-100tabs.jpg (Image 11)

Label for Lisdexamfetamine Dimesylate 60 mg oral capsules by Hikma Pharmaceuticals USA Inc. The label indicates a package of 100 capsules, includes storage instructions, dosing reference, and a barcode. It prominently shows the 60 mg strength on a blue and orange background and states dispensing information for pharmacists.*

FDA Label Image

70mg-100tabs.jpg (Image 12)

Label for Lisdexamfetamine Dimesylate capsules, 70 mg strength, distributed by Hikma Pharmaceuticals USA Inc. The label indicates packaging of 100 capsules and provides storage conditions, pharmacist medication guide instructions, an NDC number 0054-0375-25, and a barcode.*

FDA Label Image

Figure-8.jpg (Image 13)

A Kaplan-Meier curve chart comparing the proportion of subjects with release over time (days after randomization) between Lisdexamfetamine Dimesylate and placebo groups. The chart includes a legend and a table of subjects at risk at various time points for both groups.*

FDA Label Image

Figure-2.jpg (Image 14)

A fold change chart depicting pharmacokinetic (PK) parameters Cmax and AUC for guanfacine, venlafaxine, and omeprazole. The chart shows the fold change and 90% confidence interval (CI) for each drug relative to a reference, with a horizontal axis labeled "Change relative to reference" ranging from 0.0 to 2.0.*

FDA Label Image

Figure-3.jpg (Image 15)

A graph showing fold change and 90% confidence intervals of pharmacokinetic parameters (Cmax and AUC) for various interacting drugs including Guanfacine, Venlafaxine, CYP1A2 substrate Caffeine, CYP2D6 substrate Dextromethorphan, CYP2C19 substrate Omeprazole, and CYP3A substrate Midazolam. The x-axis represents changes relative to reference values.*

* 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.