Dexmethylphenidate Hydrochloride Capsule, Extended Release
Product Images NDC 31722-235

Product Visual Gallery

This gallery contains 19 technical images submitted to the FDA as part of the official labeling for Dexmethylphenidate Hydrochloride (NDC 31722-235). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Camber 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.

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10 mg (10 mg 100s)

Label for Dexmethylphenidate Hydrochloride Extended-Release Capsules 10 mg by Camber Pharmaceuticals, Inc. The package contains 100 capsules. The label includes storage instructions, dosage note to see package insert, and manufacturer details for Ascent Pharmaceuticals, Inc. and Camber Pharmaceuticals, Inc. A barcode and caution for child-resistant container are also shown.*

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15 mg (15 mg 100s)

Label for Dexmethylphenidate Hydrochloride Extended-Release Capsules 15 mg by Camber Pharmaceuticals, Inc. The label indicates a package containing 100 capsules. It includes storage instructions, dosage note, and manufacturer information.*

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20 mg (20 mg 100s)

Packaging label for DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules 20 mg by Camber Pharmaceuticals, Inc. Label indicates a package of 100 capsules with prescription use only (Rx only). Storage and dispensing instructions, manufacturer details, and medication guide references are included on the label.*

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25 mg (25 mg 100s)

Label for DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, 25 mg strength. The package contains 100 capsules and is labeled for pharmacist dispensing with medication guide instructions. Manufactured by Ascent Pharmaceuticals, Inc. and labeled for Camber Pharmaceuticals, Inc. Storage, dosage, and handling instructions are also provided on the label.*

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30 mg (30 mg 100s)

Packaging label for Dexmethylphenidate Hydrochloride Extended-Release Capsules 30 mg by Camber Pharmaceuticals, Inc. The label displays the NDC 31722-234-01, quantity of 100 capsules, and usage instructions including dispensing the medication guide. It also provides storage conditions, manufacturer information, and a barcode.*

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35mg (35 mg 100s)

Label for Dexmethylphenidate Hydrochloride Extended-Release Capsules 35 mg by Camber Pharmaceuticals, Inc. The label indicates 100 capsules per container and prescription use only. It includes storage instructions, medication guide information, and manufacturer details (Ascent Pharmaceuticals, Inc. and Camber Pharmaceuticals, Inc.). The NDC number is 31722-235-01.*

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40 mg (40 mg 100s)

Label for Dexmethylphenidate Hydrochloride Extended-Release Capsules 40 mg by Camber Pharmaceuticals, Inc. The label states this is a prescription drug with 100 capsules per container. It includes storage instructions, a pharmacist dispensing note, and manufacturer details for Ascent Pharmaceuticals and Camber Pharmaceuticals.*

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5 mg (5 mg 100s)

Dexmethylphenidate Hydrochloride Extended-Release Capsules 5 mg by Camber Pharmaceuticals, Inc. The label indicates 100 capsules in the package with pharmacist instructions to dispense the Medication Guide separately. It includes storage instructions and manufacturer details for Ascent Pharmaceuticals, Inc. and Camber Pharmaceuticals, Inc.*

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Effects-children (Effects Children 6 To 17 Yrs)

A bullet-point list showing side effects that include dyspepsia, decreased appetite, headache, and anxiety. The text is part of a drug information panel presumably related to dexmethylphenidate hydrochloride capsules, extended-release.*

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Effects-adults (Effects In Adults)

The image shows a partial list of side effects including dry mouth, dyspepsia, headache, anxiety, and pharyngolaryngeal pain. This appears to be a segment of a drug facts or patient information panel related to dexmethylphenidate hydrochloride extended-release capsules.*

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Figure 1 (Figure 1)

A line graph showing mean dexmethylphenidate plasma concentration (ng/mL) over time (hours) after administration of 20 mg dexmethylphenidate hydrochloride extended-release capsules compared to two 10 mg immediate-release tablets. The plot displays concentration-time profiles with two curves representing the extended-release and immediate-release forms over a 24-hour period.*

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Table 1 (Table 1)

A table listing common adverse reactions in pediatric patients aged 6 to 17 with ADHD treated with dexmethylphenidate hydrochloride extended-release capsules compared to placebo. The table categorizes reactions by system organ class, including gastrointestinal, metabolism and nutrition, nervous system, and psychiatric disorders, with percentages of patients affected in each group.*

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Table 2 (Table 2)

A data table titled 'Dose-Related Adverse Reactions in Pediatric Patients (6 to 17 years of age) with ADHD' showing percentages of various adverse reactions across three dose groups of Dexmethylphenidate Hydrochloride Extended-Release Capsules (10 mg/day, 20 mg/day, and 30 mg/day) and a placebo group. The table categorizes reactions by system organ class, including gastrointestinal disorders, metabolism and nutritional disorders, psychiatric disorders, and other adverse reactions.*

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Table 3 (Table 3)

A data table titled 'Dose-Related Adverse Reactions in Adult Patients (18 to 60 years of age) with ADHD' comparing adverse reaction rates across three doses (20 mg, 30 mg, 40 mg) of Dexmethylphenidate Hydrochloride Extended-Release Capsules and Placebo. It lists system organ classes including Gastrointestinal, Nervous System, Psychiatric, and Respiratory, Thoracic, and Mediastinal Disorders, with specific reactions like dry mouth, headache, anxiety, and pharyngolaryngeal pain, presenting their percentage incidence in each group.*

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Table 4 (Table 4)

A data table titled 'Changes (Mean ± SD) in Vital Signs and Weight by Randomized Dose During Double-Blind Treatment–Adults' presenting mean and standard deviation values for pulse (bpm), diastolic blood pressure (mmHg), and weight (kg). The table compares results across dexmethylphenidate hydrochloride extended-release capsule doses of 20 mg, 30 mg, 40 mg, and placebo groups, with sample sizes for each group provided.*

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Table 5 (Table 5)

Table listing clinically important drug interactions with dexmethylphenidate hydrochloride extended-release capsules. It details monoamine oxidase inhibitors (MAOIs), antihypertensive drugs, halogenated anesthetics, and risperidone, including clinical impacts, recommended interventions, and example drugs for each category.*

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Table 6 (Table 6)

A data table titled 'Summary of Efficacy Results from ADHD Study in Pediatric Patients (6–17 years) (Study 1)' summarizing the treatment effects of dexmethylphenidate hydrochloride extended-release capsules 5-30 mg/day versus placebo. The table presents primary efficacy measure CADS-T total scores, including mean baseline scores, least-squares mean change from baseline, and placebo-subtracted differences with confidence intervals, for the studied pediatric groups.*

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Table 7 (Table 7)

Table summarizing efficacy results from an adult ADHD study (Study 4) comparing dexmethylphenidate hydrochloride extended-release capsules at dosages of 20 mg/day, 30 mg/day, and 40 mg/day versus placebo. The table presents baseline scores, least-squares mean changes from baseline, and placebo-subtracted differences in ADHD-RS total scores.*

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Structure (Struct)

Chemical structure of dexmethylphenidate hydrochloride showing the molecular arrangement including a phenyl group, piperidine ring, and methyl ester functional group with hydrochloride (HCl) indicated.*

* 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.