Tramadol Hydrochloride
Product Images NDC 45865-976

6 FDA label images from Medsource Pharmaceuticals · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Tramadol Hydrochloride (NDC 45865-976). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Medsource Pharmaceuticals, 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-1 (33a5de83 A974 48a5 8ba6 4c1b97515615 01)

Image-1 (33a5de83 A974 48a5 8ba6 4c1b97515615 01)
Chemical structure of TRAMADOL HYDROCHLORIDE, showing its molecular formula with key functional groups including a methoxyphenyl group, a cyclohexanol ring, and a dimethylaminomethyl side chain.*
FDA Label Image

Image-2 (33a5de83 A974 48a5 8ba6 4c1b97515615 02)

Image-2 (33a5de83 A974 48a5 8ba6 4c1b97515615 02)
A line graph comparing the concentration of Tramadol in ng/mL over 24 hours for two formulations: Tramadol Hydrochloride Extended-Release Tablets 200 mg given once daily (q.d.) shown with black circles, and Tramadol Hydrochloride Tablets 50 mg given every 6 hours (q6h) shown with white circles. The x-axis represents time in hours, and the y-axis shows Tramadol concentration in ng/mL.*
FDA Label Image

Image-3 (33a5de83 A974 48a5 8ba6 4c1b97515615 03)

Image-3 (33a5de83 A974 48a5 8ba6 4c1b97515615 03)
A line graph comparing M1 metabolite concentration (ng/mL) over 24 hours between Tramadol Hydrochloride Extended-Release Tablets 200 mg once daily and Tramadol Hydrochloride Tablets 50 mg every 6 hours. The x-axis represents time in hours, and the y-axis shows M1 concentration with two data series indicated by filled and empty circles.*
FDA Label Image

Image-4 (33a5de83 A974 48a5 8ba6 4c1b97515615 04)

Image-4 (33a5de83 A974 48a5 8ba6 4c1b97515615 04)
A line graph titled 'Tramadol Hydrochloride Extended-Release Tablets Study 023 WOMAC Pain Responder Analysis' showing the percentage of patients achieving various response thresholds. The x-axis represents response threshold in percent improvement from baseline (0 to 100%), and the y-axis represents percent of patients achieving response (0 to 60%). The graph compares Tramadol Hydrochloride extended-release tablets at 100 mg, 200 mg, 300 mg, and 400 mg doses with placebo, indicating how patient response varies across doses and thresholds.*
FDA Label Image

Image-5 (33a5de83 A974 48a5 8ba6 4c1b97515615 05)

Image-5 (33a5de83 A974 48a5 8ba6 4c1b97515615 05)
A line graph titled 'Tramadol Hydrochloride Extended-Release Tablets Study 015 Arthritis Pain Intensity VAS Responder Analysis Patients Achieving Various Levels of Response Threshold' showing percent of patients achieving response on the y-axis and response threshold (percent improvement from baseline) on the x-axis. Two curves compare Tramadol Hydrochloride Extended-Release Tablets (circles) versus placebo (crosses), illustrating a higher percentage of responders at all threshold levels for the Tramadol group.*
FDA Label Image

Pdp (976)

Pdp (976)
Label for TRAMADOL HCL ER Tablets 200mg, generic for Ultram ER, containing 30 tablets. The label shows the lot number, expiration date fields, imprint code "CIV", and warnings about dizziness and alcohol. It includes dosing instructions to take one tablet every specified hours as needed for pain. The labeler is Medsource Pharmaceuticals, with Lupin Limited cited as the manufacturer.*

* 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.