Hydromorphone Hydrochloride Tablet, Extended Release
Product Images NDC 0574-0295

11 FDA label images from Padagis Us Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Hydromorphone Hydrochloride (NDC 0574-0295). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Padagis Us 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.

FDA Label Image

Structural Formula (Image 01)

Structural Formula (Image 01)
Chemical structure of hydromorphone hydrochloride showing its molecular arrangement including a benzene ring, hydroxyl group, and hydrochloride component.*
FDA Label Image

Figure 1. (Figure One)

Figure 1. (Figure One)
A line graph titled 'Mean Steady-State Plasma Concentration Profile' showing plasma hydromorphone concentration (ng/mL) over time (hours). It compares Hydromorphone Hydrochloride Extended-Release Tablets 16 mg given every 24 hours with HMIR 4 mg given every 6 hours, displaying their concentration levels between 96 and 120 hours.*
FDA Label Image

Figure 2. (Figure 2)

Figure 2. (Figure 2)
A line graph comparing the percentage of patients improved at week 12 between hydromorphone hydrochloride extended-release tablets and placebo. The x-axis represents percent of reduction or improvement in pain (0 to 100%), and the y-axis shows the percentage of patients improved. Two lines plot results for hydromorphone hydrochloride and placebo groups.*
FDA Label Image

8mg Label (8mg 1b578rcf4)

8mg Label (8mg 1b578rcf4)
Hydromorphone hydrochloride extended-release tablets 8 mg by Padagis US LLC. The label states "Once Daily" dosing and specifies the product is for opioid-tolerant patients only. The package contains 100 tablets. Storage instructions and manufacturer information are also provided.*
FDA Label Image

Serialization Template 8mg (Serialization Template)

Serialization Template 8mg (Serialization Template)
A black-and-white label panel showing placeholders for product information including serial number (S/N), lot number (Lot), and expiration date (Exp). Text prompts users to insert the product's serial number, lot number, and expiration date accordingly. No specific drug branding or strength is visible.*
FDA Label Image

12mg Label (12mg 0g978rcf4)

12mg Label (12mg 0g978rcf4)
Label for hydromorphone hydrochloride extended-release tablets, 12 mg strength. The label indicates a once-daily oral dosage form, with 100 tablets per container. It is intended for opioid-tolerant patients only and is manufactured by Padagis US LLC. The label includes storage instructions and a barcode on the left side.*
FDA Label Image

Serialization Template 12mg (Serialization Template 01)

Serialization Template 12mg (Serialization Template 01)
A drug facts panel placeholder including fields for serial number (S/N), lot number, and expiration date (Exp) to be filled in with specific product information. The text is in a black rectangular border on a white background.*
FDA Label Image

16mg Label (16mg 6p278rcf4)

16mg Label (16mg 6p278rcf4)
Label for hydromorphone hydrochloride extended-release oral tablets, 16 mg strength, by Padagis US LLC. The label indicates the product is for once-daily administration, contains 100 tablets, and is for opioid-tolerant patients only. It includes storage instructions, manufacturer information, a barcode, and website details for medication guides.*
FDA Label Image

Serialization Template 16mg (Serialization Template 02)

Serialization Template 16mg (Serialization Template 02)
A drug information panel template showing placeholders for serial number (S/N), lot number, and expiration date (Exp) with instructions to insert the product's specific details. The format is presented in a simple, black-bordered box with clear labels.*
FDA Label Image

32mg Label (32mg 5p178rcf3)

32mg Label (32mg 5p178rcf3)
Label for hydromorphone hydrochloride extended-release tablets, 32 mg strength, oral dosage form. The label indicates it is for once-daily use and intended for opioid-tolerant patients only. The package contains 100 tablets. Manufactured and labeled by Padagis US LLC, Minneapolis, MN. Includes instructions to swallow tablets whole and storage conditions.*
FDA Label Image

Serialization Template 32mg (Serialization Template 03)

Serialization Template 32mg (Serialization Template 03)
Label panel showing placeholders for serial number (S/N), lot number, and expiration date (Exp) for a pharmaceutical product, formatted as text fields to be filled with specific product information.*

* 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.