Concerta Tablet, Extended Release
Product Images NDC 50458-586

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Concerta (NDC 50458-586). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Janssen 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 (Concerta 01)

Chemical structure diagram of methylphenidate hydrochloride, showing the molecular arrangement including aromatic rings, ester and amine groups, and the hydrochloride salt.*

FDA Label Image

Figure 1 (Concerta 02)

A pharmacokinetic line graph depicting mean plasma methylphenidate concentration (ng/mL) over time (hours) comparing CONCERTA 18 mg once daily and Methylphenidate 5 mg three times daily. The x-axis shows time up to 32 hours, and the y-axis shows concentration from 0 to 5 ng/mL, illustrating concentration changes following different dosing regimens.*

FDA Label Image

Figure 2 (Concerta 03)

A bar chart comparing Inattention/Overactivity Scale scores between CONCERTA (once daily) and placebo groups across three studies. The vertical axis shows scores from 0 to 15, with CONCERTA represented by black bars and placebo by white bars. Each study includes two bars showing lower scores for CONCERTA compared to placebo.*

FDA Label Image

Figure 3 (Concerta 04)

A line graph comparing combined attention subscale scores over 12 hours post initial dose between CONCERTA once daily (methylphenidate hydrochloride) and placebo. The vertical axis represents attention levels, ranging from more attentive to less attentive, while the horizontal axis shows hours post dose. Data includes mean and standard error values.*

FDA Label Image

Principal Display Panel (18 mg Tablet Bottle Label)

Label for CONCERTA 18 mg extended-release tablets containing methylphenidate hydrochloride. The label states it is distributed by Janssen Pharmaceuticals, Inc., includes barcode and lot information spaces, and indicates a package size of 100 tablets. Storage instructions and a caution to keep out of reach of children are visible.*

FDA Label Image

Principal Display Panel (27 mg Tablet Bottle Label)

Label for CONCERTA 27 mg extended-release tablets containing methylphenidate hydrochloride. The label indicates each tablet contains 27 mg of the active ingredient in a controlled-release formulation. It is distributed by Janssen Pharmaceuticals, Inc. and includes the NDC 50458-588-01. The package contains 100 tablets and is for oral use with prescription only.*

FDA Label Image

Principal Display Panel (36 mg Tablet Bottle Label)

Label for CONCERTA 36 mg extended-release tablets, containing methylphenidate hydrochloride, labeled as 100 tablets. The label includes directions for dosage, storage temperature range of 15-30°C (59-86°F), and safety advice to keep out of reach of children. The product is distributed by Janssen Pharmaceuticals, Inc.*

FDA Label Image

Principal Display Panel (54 mg Tablet Bottle Label)

CONCERTA 54 mg extended-release tablets label for oral use by Janssen Pharmaceuticals, Inc. The label includes the proprietary name, generic name methylphenidate HCl, dosage strength of 54 mg, and states the product contains 100 tablets. Additional information includes storage instructions, dosage guidance, and a barcode.*

* 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.