Tramadol Hydrochloride
Product Images NDC 61919-583

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Tramadol Hydrochloride (NDC 61919-583). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Direct Rx, 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

Image Description (Figure2)

A line graph titled 'Tamadol ER Tablets Study 023' shows the percent of patients achieving response against various levels of response threshold (percent improvement from baseline). The graph compares five groups: Tramadol ER at 100 mg, 200 mg, 300 mg, and 400 mg doses, plus placebo, demonstrating a trend of decreasing patient response as the response threshold increases.*

FDA Label Image

Image Description (Figure3)

A line graph titled 'Figure 3 Tamadol ER Tablets Study 015 Arthritis Pain Intensity VAS Responder Analysis.' It shows percent of patients achieving various response thresholds of pain improvement over baseline for Tramadol ER versus placebo. The x-axis is response threshold (percent improvement), and the y-axis is percent of patients achieving responses, with Tramadol ER having higher responder rates than placebo across thresholds.*

FDA Label Image

Image Description (Label)

Label for Tramadol Hydrochloride Extended Release 150 mg capsules, 30 count, by Direct Rx. The label includes the proprietary name Tramadol HCL ER C-IV, strength 150 mg, quantity of 30 capsules, lot number 583-30, discard date 02/17, and packaging information. It also warns to keep out of reach of children and notes the medication may cause dizziness, nausea, headache, dry mouth, and diarrhea.*

FDA Label Image

Image Description (Molecule)

Chemical structure of tramadol hydrochloride represented by a molecular diagram including atoms and bonds, with the molecular formula C15H22NO2·HCl indicated underneath.*

FDA Label Image

Image Description (Table1)

A data table showing the incidence percentages of adverse reaction rates above 5% from four double-blind, placebo-controlled studies involving patients with moderate to moderately severe chronic pain. It compares rates for Tramadol Hydrochloride extended-release doses and placebo across several side effects such as headache, nausea, somnolence, dizziness, constipation, and others across different study cohort sizes.*

FDA Label Image

Image Description (Table2)

A table presenting dosage amounts of tramadol hydrochloride, comparing immediate-release and extended-release forms. It includes 150 mg total dosage, with 37.5 mg for immediate-release and 112.5 mg for extended-release.*

FDA Label Image

Image Description (Table3)

Data table presenting mean steady-state pharmacokinetic parameter values for Tramadol hydrochloride extended-release capsules 200 mg and a reference extended-release Tramadol product 200 mg, including parameters for Tramadol and its metabolite O-Desmethyl-Tramadol (M1). Parameters shown include AUC0-24, Cmax, Cmin, Tmax, and % Fluctuation, with values and %CV for a sample size of 38.*

* 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.