Methylphenidate Hydrochloride Tablet, Extended Release
Product Images NDC 72865-136

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Methylphenidate Hydrochloride (NDC 72865-136). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Xlcare 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

18 mg

Label for Methylphenidate Hydrochloride Extended-Release Tablets USP, 18 mg strength. The oral extended-release tablet package contains 100 tablets, labeled for prescription use only. The label includes storage instructions, pharmacist dispensing guidance, and manufacturer information by XL Care Pharmaceuticals, Inc. and Ascent Pharmaceuticals, Inc. The NDC number 72865-133-01 is printed on the label.*

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27 mg

Label for Methylphenidate Hydrochloride Extended-Release Tablets, USP, 27 mg strength. The label shows the product name, strength, and form as extended-release tablets. It specifies a package of 100 tablets for oral use, labeled Rx Only. The labeler is XLCare Pharmaceuticals, Inc., with manufacturing information by Ascent Pharmaceuticals, Inc. Storage and dosage instructions are partially visible.*

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36 mg

Label for Methylphenidate Hydrochloride Extended-Release Tablets, USP 36 mg by XLCare Pharmaceuticals, Inc. The label includes the NDC 72865-135-01, a 100-tablet count, dosing note to dispense the medication guide to patients, storage instructions, and manufacturing details for XLCare Pharmaceuticals and Ascent Pharmaceuticals.*

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54 mg

Label for Methylphenidate Hydrochloride Extended-Release Tablets, USP 54 mg by XLCare Pharmaceuticals, Inc. The label shows NDC 72865-136-01 and indicates 100 tablets in the package. It includes storage instructions and manufacturing information from Ascent Pharmaceuticals, Inc.*

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Figure1

A line graph depicting mean plasma methylphenidate concentrations (ng/mL) over time (hours) in 36 adults following a single dose of methylphenidate hydrochloride extended-release tablets 18 mg once daily compared with immediate-release methylphenidate 5 mg taken three times daily every 4 hours. The graph shows concentration changes over a 32-hour period with two plotted lines representing each dosing regimen.*

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Figure2

A bar graph comparing mean Community School Teacher IOWA Conners Inattention/Overactivity Scores for methylphenidate hydrochloride extended-release tablets (18, 36, or 54 mg once daily) versus placebo. It shows results from three studies with symptom scores on the y-axis, including sample sizes. Black bars represent methylphenidate and white bars represent placebo, with error bars indicating standard error of the mean.*

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Figure3

A line graph titled 'Laboratory School Teacher SKAMP Ratings: Mean (SEM) of Combined Attention' showing attention levels over 12 hours post initial dose. It compares methylphenidate hydrochloride extended-release tablets once daily (solid line) with placebo (dashed line) on a combined attention subscale, indicating drug and placebo effects on attentiveness throughout the time period.*

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Struct

Chemical structure diagram of Methylphenidate Hydrochloride, showing its molecular arrangement including a phenyl ring, piperidine ring, and ester functional groups, consistent with the active ingredient in the listed product.*

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Table1

Table showing recommended starting doses and dose ranges of Methylphenidate Hydrochloride extended-release tablets by patient age group: for children 6-12 years, starting dose 18 mg/day, range 18 mg to 54 mg/day; adolescents 13-17 years, starting dose 18 mg/day, range 18 mg to 72 mg/day not to exceed 2 mg/kg/day; adults 18-65 years, starting doses 18 or 36 mg/day, range 18 mg to 72 mg/day.*

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Table2

A table titled 'Recommended Dose Conversion from Methylphenidate Regimens to Methylphenidate Hydrochloride Extended-Release Tablets.' It shows previous daily doses of methylphenidate taken two or three times daily and the corresponding recommended starting doses of methylphenidate hydrochloride extended-release tablets taken every morning, with doses ranging from 5 mg to 20 mg previously, converted to 18 mg to 72 mg extended-release tablets.*

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Table3

A table titled 'Methylphenidate Hydrochloride Extended-Release Tablets Exposure in Double-Blind and Open-Label Clinical Studies' summarizing patient populations (Children, Adolescents, Adults), number of participants, and dose ranges used in studies. Dose ranges vary from 18 to 54 mg once daily for children, 18 to 72 mg once daily for adolescents, and 18 to 108 mg once daily for adults.*

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Table4

Table showing adverse reactions reported by 1% or more of children and adolescent subjects treated with Methylphenidate Hydrochloride extended-release tablets versus placebo in four placebo-controlled clinical trials. The table categorizes adverse reactions by system/organ class and lists percentages for reactions such as upper abdominal pain, vomiting, pyrexia, nasopharyngitis, dizziness, insomnia, cough, and oropharyngeal pain.*

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Table5

Data table presenting adverse reactions reported by 1% or more of adults treated with Methylphenidate Hydrochloride extended-release tablets compared to placebo in placebo-controlled, double-blind clinical trials. The table lists system or organ classes and specific adverse reactions with corresponding percentages for both treatment and placebo groups.*

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Table6

A table presenting pharmacokinetic parameters (mean ± SD) after a single dose in healthy adults, comparing methylphenidate hydrochloride extended-release tablets (18 mg once daily) and methylphenidate (5 mg three times daily). Parameters include Cmax, Tmax, AUCinf, and half-life (t1/2).*

* 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.