Methylphenidate Hydrochloride
Product Images NDC 50268-545

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Methylphenidate Hydrochloride (NDC 50268-545). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Avpak, 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 (545 12 18mg)

Methylphenidate Hydrochloride Extended-Release Tablets, USP 18 mg by AvPAK. The label shows this is a prescription medication with a package containing 20 tablets (4 x 5 unit dose). The label features NDC 50268-545-12, pharmacist dispensing instructions, storage conditions, and is manufactured for AvKARE in Pulaski, TN.*

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27 (546 12 27mg)

Label for Methylphenidate Hydrochloride Extended-Release Tablets USP, 27 mg, manufactured by AvPAK. The label states Rx Only and indicates 20 tablets per package (4 x 5 unit dose). It includes storage instructions, pharmacist dispensing notice, and manufacturer location in Pulaski, TN. Two identical barcode images and NDC numbers are present.*

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36 (547 12 36mg)

Label for Methylphenidate Hydrochloride Extended-Release Tablets, USP, 36 mg, manufactured by AvPAK. The label indicates 20 tablets per package (4 x 5 unit dose) with two barcodes and states 'Rx Only.' Storage instructions and pharmacist dispensing notes are also visible.*

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54 (548 12 54mg)

Packaging label for Methylphenidate Hydrochloride Extended-Release Tablets USP 54 mg by AvPAK. The label shows two identical sections stating 20 tablets (4 x 5 unit dose) with the NDC 50268-548-12, instructions for dispensing the medication guide, and storage conditions. The label includes a barcode, pharmacist instructions, and the AvPAK logo.*

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Fig1 (Methylphenidate Fig1)

A line graph comparing mean plasma methylphenidate concentration (ng/mL) over time (hours) for two dosing regimens: 18 mg extended-release once daily and 5 mg immediate-release three times daily. The X-axis represents time in hours up to 32 hours, and the Y-axis represents concentration from 0 to 5 ng/mL.*

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Fig2 (Methylphenidate Fig2)

A bar chart comparing the maximum symptoms of inattention/overactivity on a scale from 0 to 15 across three studies labeled Study 1, Study 2, and Study 3 (Week 4). The chart shows results for Methylphenidate Hydrochloride extended-release tablets taken once daily versus placebo, with Methylphenidate bars consistently lower than placebo bars in all studies, indicating reduced symptoms with the active treatment.*

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Fig3 (Methylphenidate Fig3)

A line graph depicting combined attention subscale scores over time in hours post initial dose. It compares methylphenidate hydrochloride extended-release tablets once daily (solid line with circles) versus placebo (dashed line with X marks), illustrating changes in attentiveness from 1 to 12 hours after dosing.*

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Structure (Methylphenidate Struct)

Chemical structure of Methylphenidate Hydrochloride, showing its molecular configuration including the phenyl group, piperidine ring, methyl ester, and hydrochloride salt.*

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Tb1 (Methylphenidate Table1)

A table presenting recommended starting doses and dose ranges for Methylphenidate Hydrochloride extended-release tablets by patient age group. It includes dosing guidelines for children (6-12 years), adolescents (13-17 years), and adults (18-65 years), specifying daily dosages in milligrams and maximum limits.*

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T2 (Methylphenidate Table2)

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

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Table3 (Methylphenidate Table3)

Data table titled 'Methylphenidate hydrochloride extended-release tablets Exposure in Double-Blind and Open-Label Clinical Studies' showing patient populations of children, adolescents, and adults with corresponding sample sizes and dose ranges.*

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Table 4 (Methylphenidate Table4)

A data table listing adverse reactions reported by 1% or more of children and adolescent subjects treated with Methylphenidate Hydrochloride extended-release tablets versus placebo in clinical trials. The table categorizes adverse reactions by system/organ class, including gastrointestinal disorders, general disorders, infections, nervous system, psychiatric, and respiratory disorders, showing the percentage incidence for both treatment and placebo groups.*

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Table5 (Methylphenidate Table5)

A table listing adverse reactions by system or organ class comparing the incidence percentage between Methylphenidate hydrochloride extended-release tablets (n=415) and placebo (n=212). Categories include cardiac, ear and labyrinth, eye, gastrointestinal, general disorders, infections, metabolism, musculoskeletal, nervous system, psychiatric, respiratory, and skin disorders, each with specific symptoms and their respective percentage occurrences in both groups.*

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Tb 6 (Methylphenidate Table6)

A data table titled 'Pharmacokinetic Parameters (Mean ± SD) After Single Dose in Healthy Adults' comparing methylphenidate hydrochloride extended-release tablets (18 mg once daily, n=36) with methylphenidate (5 mg three times daily, n=35). It lists parameters including Cmax, Tmax, AUCinf, and t½ with corresponding mean values and standard deviations for each formulation.*

* 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.