Lisdexamfetamine Dimesylate Capsule
Product Images NDC 0378-6858

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Lisdexamfetamine Dimesylate (NDC 0378-6858). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Mylan 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

Chemical Structure (Image 08)

A line graph comparing the proportion of subjects with relapse or treatment failure over time (days after randomization) between placebo and lisdexamfetamine groups. The graph shows relapse rates increasing over time with placebo, while remaining low and stable for lisdexamfetamine.*

FDA Label Image

Figure 2 (Image 10)

Lisdexamfetamine Dimesylate 10 mg capsules label from Mylan Pharmaceuticals Inc. The label shows the product name, dosage strength (10 mg), dosage form (capsules), and container count (90 capsules). It includes storage instructions, a barcode, and a note for pharmacists to dispense the accompanying Medication Guide. The label features the NDC number 0378-6854-77 and manufacturer location Morgantown, WV.*

FDA Label Image

Figure 3 (Image 11)

Label for Lisdexamfetamine Dimesylate Capsules 20 mg by Mylan Pharmaceuticals Inc., containing 90 capsules. The label includes NDC 0378-6855-77, dosage instructions, storage recommendations, and a barcode. It states the product is for prescription use only (Rx only) and features a note for pharmacists to dispense the accompanying Medication Guide.*

FDA Label Image

Figure 1 (Image 09)

A Kaplan-Meier survival curve chart comparing the proportion of subjects with relapse over time between lisdexamfetamine and placebo groups. The x-axis represents days after randomization, and the y-axis shows the proportion of subjects with relapse in percentage. The chart includes subject numbers at risk for both groups at various time points.*

FDA Label Image

Figure 4 (Image 12)

Label for Lisdexamfetamine Dimesylate capsules 30 mg by Mylan Pharmaceuticals Inc. The label shows a capsule image, NDC 0378-6856-77, and indicates the package contains 90 capsules. It includes storage instructions, a barcode, and directions for pharmacists to dispense the Medication Guide to patients. The label also notes the product is Rx only.*

FDA Label Image

Figure 5 (Image 13)

Lisdexamfetamine Dimesylate 40 mg capsules label from Mylan Pharmaceuticals Inc. The label indicates the product is for oral use, comes in a container of 90 capsules, and is prescription-only. It includes dosage instructions to dispense the accompanying medication guide and storage instructions to keep the capsules in a tight, light-resistant container at 20 to 25°C. The label also features the NDC number 0378-6857-77 and a barcode.*

FDA Label Image

Figure 6 (Image 14)

Lisdexamfetamine Dimesylate 50 mg oral capsules packaging label features product name, strength, dosage form, and a front-facing image of blue and white capsules. The label includes NDC 0378-6858-77, Mylan Pharmaceuticals Inc. as the manufacturer, a child-resistant container warning, storage instructions to keep between 20°C and 25°C, and a barcode. It also states 'Rx only' and contains 90 capsules per bottle.*

FDA Label Image

Figure 7 (Image 15)

Label for Lisdexamfetamine Dimesylate capsules, 60 mg strength, manufactured by Mylan Pharmaceuticals Inc. The label states the product is prescription-only, contains 90 capsules, and includes instructions for pharmacists to dispense the Medication Guide. Storage instructions, dosage notes, and a barcode are also visible.*

FDA Label Image

Figure 8 (Image 16)

Lisdexamfetamine Dimesylate 70 mg oral capsules in a 90-capsule package labeled by Mylan Pharmaceuticals Inc. The label includes dosage instructions, storage conditions, and a barcode. It states pharmacist dispensing instructions and indicates the product is prescription-only (Rx only).*

FDA Label Image

Lisdexamfetamine Dimesylate Capsules 10 mg Bottle Label (Image 01)

Chemical structure of lisdexamfetamine dimesylate, the active ingredient shown in the molecular diagram, displaying its detailed arrangement of atoms and bonds.*

FDA Label Image

Lisdexamfetamine Dimesylate Capsules 20 mg Bottle Label (Image 02)

A chart depicting fold change and 90% confidence intervals for Cmax and AUC pharmacokinetic parameters of lisdexamfetamine dimesylate. It compares results across special populations, including gender, age groups 65-74 years and 75+ years, and levels of renal impairment from mild to end-stage renal disease, relative to a reference group.*

FDA Label Image

Lisdexamfetamine Dimesylate Capsules 30 mg Bottle Label (Image 03)

A forest plot chart illustrating the fold change and 90% confidence interval in pharmacokinetic parameters (Cmax and AUC) of lisdexamfetamine when co-administered with guanfacine, venlafaxine, and omeprazole. The x-axis shows change relative to reference, ranging from 0.0 to 2.0, with data points clustered around 1.0.*

FDA Label Image

Lisdexamfetamine Dimesylate Capsules 40 mg Bottle Label (Image 04)

A scatter plot showing pharmacokinetic (PK) fold changes and 90% confidence intervals for various interacting drugs relative to a reference; drugs listed include Guanfacine, Venlafaxine, CYP1A2 substrates like Caffeine, CYP2D6 substrates like Dextromethorphan, CYP2C19 substrates like Omeprazole, and CYP3A substrates like Midazolam, with measurements for Cmax and AUC.*

FDA Label Image

Lisdexamfetamine Dimesylate Capsules 50 mg Bottle Label (Image 05)

A line graph depicting the LS Mean (SE) SKAMP Deportment Scores over time post-dose in hours for lisdexamfetamine and placebo. The x-axis shows time from -0.5 to 13 hours, and the y-axis ranges from 0.0 to 2.0 scores. The graph compares treatment performance over time with error bars indicating variability.*

FDA Label Image

Lisdexamfetamine Dimesylate Capsules 60 mg Bottle Label (Image 06)

A line graph comparing the proportion of subjects with relapse or treatment failure (%) over time (days after randomization) between lisdexamfetamine and placebo groups. The graph shows time on the x-axis (0 to 55 days) and proportion of subjects on the y-axis (0 to 100%). The lisdexamfetamine group is represented by a solid line, while the placebo group is represented by a dashed line.*

FDA Label Image

Lisdexamfetamine Dimesylate Capsules 70 mg Bottle Label (Image 07)

A line graph comparing LS Mean (SE) PERMP Total Scores over time post-dose (hours) for Placebo and Lisdexamfetamine. The x-axis shows time from -0.5 to 14 hours post-dose, and the y-axis shows score values from 250 to 330. Lisdexamfetamine scores increase and plateau higher than Placebo scores, with error bars shown for each time point.*

* 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.