Ultram Er
Product Images NDC 21695-913

8 FDA label images from Rebel Distributors Corp · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Ultram Er (NDC 21695-913). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Rebel Distributors Corp, 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

Chemical Structure (2fd193e2 7aa7 4119 B540 7e28e82fbd13 01)

Chemical Structure (2fd193e2 7aa7 4119 B540 7e28e82fbd13 01)
Chemical structure diagram of the active ingredient purportedly associated with ULTRAM ER, showing molecular groups including methoxy (OCH3), hydroxyl (HO), and methylamine elements. The structure also indicates the presence of a hydrochloride component (.HCl).*
FDA Label Image

Graph #1 (2fd193e2 7aa7 4119 B540 7e28e82fbd13 02)

Graph #1 (2fd193e2 7aa7 4119 B540 7e28e82fbd13 02)
A line graph showing tramadol concentration (ng/mL) over 24 hours comparing ULTRAM ER Tablets 200 mg taken once daily (q.d.) with Ultram Tablets 50 mg taken every six hours (q6h). The x-axis represents time in hours, and the y-axis represents tramadol concentration. Two lines depict different dosing regimens and their corresponding tramadol plasma levels.*
FDA Label Image

Graph #2 (2fd193e2 7aa7 4119 B540 7e28e82fbd13 03)

Graph #2 (2fd193e2 7aa7 4119 B540 7e28e82fbd13 03)
A line chart showing M1 concentration (ng/mL) over time (hours) comparing Ultram ER 200 mg tablets taken once daily and Ultram tablets 50 mg taken every 6 hours. The graph tracks concentration levels from 0 to 24 hours post-dose.*
FDA Label Image

Graph #3 (2fd193e2 7aa7 4119 B540 7e28e82fbd13 04)

Graph #3 (2fd193e2 7aa7 4119 B540 7e28e82fbd13 04)
A line graph titled 'ULTRAM ER Study 015 Arthritis Pain Intensity VAS Responder Analysis' showing the percent of patients achieving various levels of response thresholds. The x-axis represents the response threshold as percent improvement from baseline, ranging from 0 to 100%. The y-axis shows the percent of patients achieving the response, from 0 to 60%. Two lines compare ULTRAM ER and placebo groups, with ULTRAM ER showing higher response percentages across thresholds.*
FDA Label Image

Ultram Er 100mg (2fd193e2 7aa7 4119 B540 7e28e82fbd13 05)

Ultram Er 100mg (2fd193e2 7aa7 4119 B540 7e28e82fbd13 05)
ULTRAM ER 100mg tablets packaging label from Physician Partner, showing a bottle with 30 extended-release tablets. The label identifies the product as Ultram ER 100mg with NDC 21695-292-30 and includes storage instructions and distributor information for Physician Partner, Thousand Oaks, CA.*
FDA Label Image

Ultram Er 200mg (2fd193e2 7aa7 4119 B540 7e28e82fbd13 06)

Ultram Er 200mg (2fd193e2 7aa7 4119 B540 7e28e82fbd13 06)
ULTRAM ER 200mg tablets packaging label showing a quantity of 30 tablets. The label indicates each tablet contains 200mg of tramadol HCl. The product is manufactured by Biovail Corp, Mississauga, ON, Canada, and distributed by Physician Partner, Thousand Oaks, CA. The tablets are described as round, convex, white to off-white, with imprint "238" or "ER" on one side in black ink. Storage instructions specify controlled room temperature between 15°-30°C (59°-86°F).*
FDA Label Image

Ultram Er 300mg (2fd193e2 7aa7 4119 B540 7e28e82fbd13 07)

Ultram Er 300mg (2fd193e2 7aa7 4119 B540 7e28e82fbd13 07)
ULTRAM ER 300mg tablets bottle label with NDC 21695-913-30 from Physician Partner, distributed by Rebel Distributors Corp. The label indicates each extended-release tablet contains 300mg Tramadol HCl. The package contains 30 tablets with instructions to store at controlled room temperature. The label also notes the product is RX only.*
FDA Label Image

Graph #4 (2fd193e2 7aa7 4119 B540 7e28e82fbd13 08)

Graph #4 (2fd193e2 7aa7 4119 B540 7e28e82fbd13 08)
A line graph titled 'ULTRAM ER Study 023 WOMAC Pain Responder Analysis' showing the percent of patients achieving various levels of response threshold, measured as percent improvement from baseline. The graph compares ULTRAM ER doses of 100 mg, 200 mg, 300 mg, 400 mg, and placebo, with response thresholds on the x-axis and percent of patients on the y-axis.*

* 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.