Lisdexamfetamine Dimesylate Capsule
Product Images NDC 0781-2478

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Lisdexamfetamine Dimesylate (NDC 0781-2478). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sandoz 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

10mglabel (10mglabel)

Label for Lisdexamfetamine Dimesylate Capsules 10 mg by Sandoz Inc. It specifies the product as a pharmacy bulk package containing 100 capsules. The label includes storage instructions at 20° to 25°C and advises dispensing medication guides separately. It also features a barcode and regulatory information with a precaution to keep out of reach of children.*

FDA Label Image

20mglabel (20mglabel)

Label for Lisdexamfetamine Dimesylate Capsules 20 mg from Sandoz Inc. The label shows the dosage strength prominently, indicates a package size of 100 capsules, and includes storage instructions and dispensing information. The label also notes the presence of FD&C Yellow #5 and cautions to keep out of reach of children.*

FDA Label Image

30mglabel (30mglabel)

Label for Lisdexamfetamine Dimesylate Capsules 30 mg by Sandoz Inc. The label indicates a pharmacy bulk package containing 100 capsules. It includes storage instructions, dosage guidance referencing package insert, and safety warnings to keep out of reach of children. The product is distributed by Sandoz Inc., Princeton, NJ.*

FDA Label Image

40mglabel (40mglabel)

Label for Lisdexamfetamine Dimesylate Capsules 40 mg by Sandoz Inc. The label specifies the active ingredient strength, packaging of 100 capsules, and includes storage instructions, dosage note, and warnings. It also states the product is prescription only and is distributed by Sandoz Inc, Princeton, NJ.*

FDA Label Image

50mglabel (50mglabel)

Label for Lisdexamfetamine Dimesylate Capsules 50 mg by Sandoz Inc. The label indicates the product is prescription only, contains 100 capsules, and includes storage instructions (20° to 25°C). It directs pharmacists to dispense the Medication Guide separately and notes this is a pharmacy bulk package with child-resistant closure requirements.*

FDA Label Image

60mglabel (60mglabel)

Label for Lisdexamfetamine Dimesylate Capsules 60 mg, a human prescription oral capsule by Sandoz Inc. The label states the package contains 100 capsules and highlights the dosage strength 60 mg. It includes pharmacy dispensing instructions and storage conditions, with distribution information from Sandoz Inc., Princeton, NJ.*

FDA Label Image

70mglabel (70mglabel)

Label for Lisdexamfetamine Dimesylate Capsules 70 mg, manufactured and distributed by Sandoz Inc. The pharmacy bulk package contains 100 capsules. The label includes storage instructions, dosage reference, and child-resistant closure information. The NDC 0781-2481-01 and barcode are visible on the label.*

FDA Label Image

Figure1 (Figure1)

A fold change chart with 90% confidence intervals showing pharmacokinetic parameters Cmax and AUC for lisdexamfetamine dimesylate across special populations, including gender, age groups (65-74 years, 75+ years), and degrees of renal impairment (mild to end stage renal disease). The chart illustrates changes relative to a reference with values on a horizontal axis from 0.0 to 2.5.*

FDA Label Image

Figure2 (Figure2)

A forest plot chart showing fold change and 90% confidence intervals for pharmacokinetic variables Cmax and AUC of lisdexamfetamine dimesylate when coadministered with guanfacine, venlafaxine, and omeprazole. The x-axis represents change relative to reference from 0.0 to 2.0, with data points clustered near 1.0.*

FDA Label Image

Figure3 (Figure3)

A forest plot chart showing fold changes and 90% confidence intervals in pharmacokinetic parameters (Cmax and AUC) for multiple interacting drugs with lisdexamfetamine dimesylate. Interacting drugs listed include Guanfacine, Venlafaxine, CYP1A2 substrates (Caffeine), CYP2D6 substrates (Dextromethorphan), CYP2C19 substrates (Omeprazole), and CYP3A substrates (Midazolam). The x-axis represents change relative to reference, ranging from 0.0 to 2.0.*

FDA Label Image

Figure4 (Figure4)

A line graph showing LS Mean (SE) SKAMP Deportment Scores over time post-dose (hours) comparing placebo (dashed line) and Lisdexamfetamine Dimesylate (solid line). The graph plots behavioral scores at multiple time points up to 13 hours after dosing, illustrating time-dependent changes for both treatments with error bars representing standard error.*

FDA Label Image

Figure5 (Figure5)

A Kaplan-Meier curve graph showing the proportion of subjects with relapse or treatment failure over time (days after randomization). It compares Lisdexamfetamine Dimesylate (solid line) and Placebo (dashed line), with the percentage on the Y-axis from 0 to 100% and time on the X-axis from 0 to 55 days.*

FDA Label Image

Figure6 (Figure6)

This line graph compares least squares mean PERMP total scores over time post-dose (in hours) between Lisdexamfetamine dimesylate and placebo groups. It plots scores with standard error bars, showing higher scores for Lisdexamfetamine dimesylate across 0 to 14 hours post-dose compared to placebo.*

FDA Label Image

Figure7 (Figure7)

Kaplan-Meier curve showing the proportion of subjects with relapse or treatment failure over time (days after randomization) comparing placebo and Lisdexamfetamine dimesylate. The graph illustrates a higher relapse proportion in the placebo group compared to Lisdexamfetamine dimesylate.*

FDA Label Image

Figure8 (Figure8)

A Kaplan-Meier survival curve graph depicting the estimated proportions of subjects experiencing relapse over time (days after randomization) in a clinical study of adults with binge eating disorder (BED). The graph compares lisdexamfetamine dimesylate and placebo groups, showing the relapse rates across approximately 209 days, with subjects at risk indicated at various time points below the x-axis.*

FDA Label Image

Chemicalstructure (Image 04)

Chemical structure of lisdexamfetamine dimesylate, showing the molecular components and arrangement of the active ingredient used in this prescription drug.*

* 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.