Chemical Structure (Orenitram 01)
Chemical structure of treprostinil, the active ingredient in Orenitram extended-release tablets.*
Orenitram Tablet, Extended Release
Product Images NDC 66302-325
18 FDA label images from United Therapeutics Corporation · Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 18 technical images submitted to the FDA as part of the official labeling for Orenitram (NDC 66302-325). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by United Therapeutics Corporation, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.
Product Images & Figures Index
Figure 1 (Orenitram 02)
A forest plot chart illustrating the effect of co-administered drugs on treprostinil pharmacokinetics, showing mean and 90% confidence intervals for Cmax and AUCinf values. It compares Gemfibrozil, Fluconazole, Rifampin, Sildenafil, Bosentan, and Esomeprazole, with dosing regimens and dose adjustment recommendations indicated for each.*
Figure 2 (Orenitram 03)
A bar graph showing the estimated difference between groups in 6-minute walk distance (6MWD) change from baseline (in meters) at different study visits: Week 4, Week 8, Week 12, and Week 11 Trough. Each bar is labeled with the number of subjects and corresponding p-values for statistical comparison. The x-axis represents study visits, and the y-axis shows change in 6MWD in meters, ranging from 0 to 30.*
Figure 3 (Orenitram 04)
A Kaplan-Meier curve comparing the percentage of patients achieving a greater 6-minute walk distance (6MWD) change from baseline between Orenitram (solid line) and placebo (dashed line) groups. The x-axis shows 6MWD change from baseline; the y-axis shows the percentage of patients with that change. The graph illustrates time to event analysis with treatment comparison.*
Figure 4 (Orenitram 05)
A forest plot chart illustrating the difference in 6-minute walk distance (6MWD) change from baseline in meters for various populations treated with Orenitram (treprostinil). The chart compares active treatment versus placebo across overall populations, age groups, gender, etiology, and baseline walk distances, showing confidence intervals for each subgroup.*
Figure 5 (Orenitram 06)
A Kaplan-Meier survival curve showing the percentage of patients without an event over time in weeks, comparing Orenitram (treprostinil) extended release tablets with placebo. The graph includes number of patients at risk at different time points. Orenitram is represented with a solid line and placebo with a dashed line, illustrating a higher event-free survival rate for Orenitram over approximately 130 weeks.*
Figure 6 (Orenitram 07)
A Kaplan-Meier survival curve showing the percentage of patients without an event over time in weeks, comparing Orenitram (treprostinil extended-release tablets) to placebo. The graph includes a legend indicating the solid line represents Orenitram and the dashed line represents placebo. A table below details the number of patients at risk at various time points for each group.*
Figure 7 (Orenitram 08)
A forest plot showing hazard ratios comparing Orenitram and placebo treatments across various patient subgroups, including age, sex, baseline 6-minute walk distance, WHO functional class, pulmonary arterial hypertension etiology, geographic region, and background PAH therapy. The plot displays point estimates with confidence intervals, indicating relative treatment effects for each subgroup.*
Principal Display Panel (0.125 mg Tablet Bottle Label)
Orenitram 0.125 mg extended-release tablets label showing the drug name and strength with instructions to swallow whole and not to split, chew, crush or break tablets. The label includes the NDC 66302-300-01, quantity of 100 tablets, and manufacturer United Therapeutics Corporation. Dosage and storage instructions are provided, including taking with food and specific temperature ranges.*
Principal Display Panel (0.125 mg Tablet Blister Pack Carton)
Orenitram 0.125 mg extended-release tablets packaging label showing that each tablet contains 0.125 mg of treprostinil. The label includes storage instructions, dosing directions, and warnings against splitting or crushing the tablets. The carton indicates a package size of 10 tablets (1 x 10 tablet blister pack) and is manufactured by United Therapeutics Corporation.*
Principal Display Panel (0.25 mg Tablet Bottle Label)
Orenitram 0.25 mg extended-release oral tablets label from United Therapeutics Corporation. The label includes the proprietary and generic name treprostinil, tablet strength of 0.25 mg, and instructions to swallow whole without splitting, chewing, crushing, or breaking. It also provides dosage directions, storage temperature guidelines, and states the package contains 100 tablets, Rx only.*
Principal Display Panel (0.25 mg Tablet Blister Pack Carton)
Orenitram 0.25 mg extended-release oral tablets packaging label by United Therapeutics Corporation. The label indicates a 10 tablet blister pack with each tablet containing 0.25 mg of treprostinil. Instructions note that tablets should be swallowed whole and not split, chew, crush, or break. Storage instructions and manufacturer details are included.*
Principal Display Panel (1 mg Tablet Bottle Label)
Orenitram (treprostinil) Extended-Release Tablets 1 mg strength, oral dosage form. The label indicates a bottle containing 100 tablets, with instructions to swallow whole and not to split, chew, crush, or break tablets. It includes dosing advice to take with food and storage conditions. Manufactured by United Therapeutics Corporation.*
Principal Display Panel (1 mg Tablet Blister Pack Carton)
Packaging label for Orenitram (treprostinil) extended-release tablets, 1 mg strength. The label indicates 10 tablets per blister pack, manufactured by United Therapeutics Corporation. Instructions note to swallow whole and not to split, chew, crush, or break tablets. Storage and dosing details are also included, along with the NDC 66302-310-02.*
Principal Display Panel (2.5 mg Tablet Bottle Label)
Orenitram 2.5 mg extended-release tablets with the active ingredient treprostinil. The label shows 100 tablets in the package, oral dosage form, and includes storage instructions and usage warnings. The product is manufactured by United Therapeutics Corporation under NDC 66302-325-01. The label emphasizes swallowing tablets whole without splitting, chewing, crushing, or breaking.*
Principal Display Panel (2.5 mg Tablet Blister Pack Carton)
Packaging label for Orenitram (treprostinil) extended-release tablets, 2.5 mg per tablet. The label shows a 10 tablet blister pack with instructions to swallow whole and not to split, chew, crush, or break tablets. Manufactured by United Therapeutics Corporation. The label includes storage information and a note that the package is not child resistant.*
Principal Display Panel (5 mg Tablet Bottle Label)
Label for Orenitram 5 mg extended-release tablets containing treprostinil. The label states the quantity as 100 tablets and instructs to swallow whole without splitting, chewing, crushing, or breaking. It includes storage conditions, dosage directions to take with food, and notes the product is prescription only. Manufacturer is United Therapeutics Corporation.*
Principal Display Panel (5 mg Tablet Blister Pack Carton)
Orenitram (treprostinil) extended-release tablets packaging label for 5 mg strength. The label includes dosing instructions to swallow whole and cautions not to split, chew, crush, or break tablets. Each carton contains 10 tablets (1 x 10 tablet blister pack). Manufactured by United Therapeutics Corporation, with NDC 66302-350-02.*
* 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.
