Hydromorphone Hydrochloride Tablet, Extended Release
Product Images NDC 13811-704

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Hydromorphone Hydrochloride (NDC 13811-704). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Trigen Laboratories, Llc, 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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Chemical Structure (Hydromorphone Hydrochloride Extended Release Table 1)

A table showing prior oral opioids alongside their approximate oral conversion factors. It lists Hydromorphone, Codeine, Hydrocodone, Methadone, Morphine, Oxycodone, and Oxymorphone with corresponding numerical conversion factors for each.*

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Hydromorphone Hydrochloride Extended Release Table 10

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Hydromorphone Hydrochloride Extended Release Table 11

Label for Hydromorphone Hydrochloride extended-release tablets, 8 mg strength, manufactured by Trigen Laboratories, LLC. The label indicates the product is for opioid-tolerant patients only, to be taken once daily. It contains 100 tablets and includes warnings about not breaking or crushing tablets and storage instructions. The label also features a barcode and NDC 13811-701-10.*

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Hydromorphone Hydrochloride Extended Release Table 12

Label for Hydromorphone Hydrochloride extended-release tablets, 12 mg strength. The label indicates it is for opioid-tolerant patients only and to swallow tablets whole. It is manufactured by Trigen Laboratories, LLC, packaged as 100 tablets, Rx only. Storage and warning instructions are included alongside a barcode and NDC 13811-702-10.*

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Hydromorphone Hydrochloride Extended Release Table 13

Label for Hydromorphone Hydrochloride Extended-release Tablets 16 mg by Trigen Laboratories, LLC. The label instructs to swallow tablets whole, warns to keep out of reach of children, and includes storage and pharmacist dispensing information. It shows a package size of 100 tablets, NDC 13811-703-10, and specifies Rx only for opioid tolerant patients only.*

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Hydromorphone Hydrochloride Extended Release Table 14

Label for Hydromorphone Hydrochloride extended-release tablets, 32 mg strength, manufactured by Trigen Laboratories, LLC. The label indicates the product is for opioid-tolerant patients only, with a dosage of once daily. The label includes warnings, storage instructions, and a note to dispense the Medication Guide separately. The package contains 100 tablets and is marked Rx only.*

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Figure 1 (Hydromorphone Hydrochloride Extended Release Table 2)

This table presents adverse event occurrences during the open-label titration and double-blind treatment phases for Hydromorphone Hydrochloride Extended-Release Tablets compared to placebo. It details the frequency and percentage of subjects experiencing events such as constipation, nausea, somnolence, headache, vomiting, and others in the respective groups.*

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Figure 2 (Hydromorphone Hydrochloride Extended Release Table 3)

A data table listing adverse events and their frequencies among 2,474 patients, including preferred terms such as constipation, nausea, vomiting, somnolence, headache, fatigue, dizziness, diarrhea, pruritus, insomnia, and others, with corresponding patient counts and percentages.*

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Trigen Logo (Hydromorphone Hydrochloride Extended Release Table 4)

Chemical structure of Hydromorphone Hydrochloride, illustrating the molecular arrangement including rings, hydroxyl group, methyl and ethyl groups, and the hydrochloride component (HCl).*

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Hydro8mg (Hydromorphone Hydrochloride Extended Release Table 5)

A line graph titled 'Mean Steady-State Plasma Concentration Profile' showing plasma hydromorphone levels (ng/mL) over time (hours). It compares Hydromorphone ERT 16 mg q24h with HMIR 4 mg q6h, depicting fluctuating plasma concentrations across a time span from 96 to 120 hours.*

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Hydro12mg (Hydromorphone Hydrochloride Extended Release Table 6)

A table presenting pharmacokinetic data for Hydromorphone Hydrochloride across various dosages and regimens. It includes parameters such as T max (hours), C max (ng/mL), AUC (ng·hr/mL), and T half (hours) with mean values and ranges or standard deviations for single and multiple dose administration.*

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Hydro16mg (Hydromorphone Hydrochloride Extended Release Table 7)

A line graph titled 'Percent Reduction in Average Pain Intensity from Screening to Week 12 or Final Visit' comparing Hydromorphone ERT and placebo groups. The x-axis shows percent of reduction/improvement in pain from 0 to 100%, and the y-axis shows percent of patients improved from 0 to 100%. Two lines represent pain improvement trends, with the Hydromorphone ERT group consistently showing higher patient improvement percentages versus placebo across the pain reduction scale.*

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Hydro32mg (Hydromorphone Hydrochloride Extended Release Table 8)

A data table listing Hydromorphone Hydrochloride tablets by strength (8 mg, 12 mg, 16 mg, and 32 mg) alongside their respective tablet color, description, packaging, and NDC codes. Tablets are round, biconvex, and printed with unique identifiers ('OS 211' to 'OS 214'), packaged as 100 tablets per bottle by Trigen Laboratories, LLC.*

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Hydromorphone Hydrochloride Extended Release Table 9

* 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.