Hydromorphone Hydrochloride Tablet, Extended Release
Product Images NDC 72865-170

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Hydromorphone Hydrochloride (NDC 72865-170). 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

12 mg (12 mg 100s)

Label for hydromorphone hydrochloride extended-release tablets, 12 mg strength, oral dosage form by XLCare Pharmaceuticals, Inc. The label indicates a 100-tablet bottle, intended for once daily use, with a warning stating it is for opioid tolerant patients only. Storage instructions and manufacturer details are also included.*

FDA Label Image

16 mg (16 mg 100s)

Label for hydromorphone hydrochloride extended-release tablets, 16 mg strength, from XLCare Pharmaceuticals Inc. The label states the product is for oral use, with 100 tablets per container, intended for opioid tolerant patients only. It includes storage instructions and manufacturing information for XLCare Pharmaceuticals Inc. and Ascent Pharmaceuticals, Inc.*

FDA Label Image

32 mg (32 mg 100s)

Label for Hydromorphone Hydrochloride Extended-Release Tablets 32 mg by XLCare Pharmaceuticals, Inc. The oral tablet package contains 100 extended-release tablets, indicated for once daily use. The label states it is for opioid tolerant patients only and includes storage, dosing, and manufacturing information.*

FDA Label Image

8 mg (8 mg 100s)

Label for hydromorphone hydrochloride extended-release tablets 8 mg by XLCare Pharmaceuticals, Inc. The label indicates 100 tablets per bottle for opioid tolerant patients only, with dosing instructions to swallow whole without breaking, crushing, or chewing. It includes storage instructions and manufacturer information for XLCare Pharmaceuticals and Ascent Pharmaceuticals.*

FDA Label Image

Fig-1 (Figure 1)

A line graph comparing plasma hydromorphone concentration (ng/mL) over time (hours) for hydromorphone hydrochloride extended-release tablets 16 mg every 24 hours versus HMIR 4 mg every 6 hours. The graph shows plasma levels fluctuating around 1.5 to 3.5 ng/mL with time points from 96 to 120 hours.*

FDA Label Image

Fig-2 (Figure 2)

A line graph comparing the percentage of patients improved versus the percent of reduction/improvement in pain. It features two data series: Hydromorphone Hydrochloride Extended-Release Tablets Week 12 (black squares) and HMIR Week 12 (gray circles), showing patient improvement trends over varying pain reduction percentages.*

FDA Label Image

Structure (Structure)

Chemical structure of hydromorphone hydrochloride, showing the molecular arrangement with a hydrochloride (HCl) component indicated.*

FDA Label Image

Table-5 (Table 5)

A pharmacokinetic data table comparing single and multiple dose regimens of hydromorphone hydrochloride extended-release tablets. It lists dosage amounts (8 mg to 64 mg for single dose; 16 mg q24h and IR 4 mg q6h for multiple dose), along with Tmax, Cmax, AUC, and T1/2 values, including medians and ranges for each parameter.*

* 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.