Orenitram Tablet, Extended Release
Product Images NDC 66302-310

View Photos of 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 66302-310). 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.

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Chemical Structure (Orenitram 01)

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Figure 1 (Orenitram 02)

Figure 1 (Orenitram 02)
This seems to be a table consisting of different medicines and their recommended dose adjustments in combination with another drug. The drugs listed are Gemfibrozil, Fluconazole, Rifampin, Sildenafil, Bosentan, and Esomeprazole. The quantity and duration of each drug are also mentioned. The table recommends whether the dose needs to be adjusted or not when co-administered with another drug. Additionally, the table lists the relative changes in PK, QO, Cmax, A, and AUCinf.*
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Figure 2 (Orenitram 03)

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Figure 3 (Orenitram 04)

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Figure 4 (Orenitram 05)

Figure 4 (Orenitram 05)
This appears to be a statistical analysis report of a clinical trial study. The report compares the number of participants in the active treatment group (239) and placebo group (18) and provides demographic information such as age and gender for each group. The primary analysis population includes 51 participants in the active group and 77 in the placebo group. The report also details the difference in the change in the six-minute walk distance from baseline for the two groups.*
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Figure 5 (Orenitram 06)

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Figure 6 (Orenitram 07)

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Figure 7 (Orenitram 08)

Figure 7 (Orenitram 08)
This text appears to be a table or chart containing information about subgroups of a population categorized by age, sex, geographic region, etiology of pulmonary arterial hypertension (PAH), baseline measurement of maximum walking distance (MWD), World Health Organization functional classification (WHOFC), and background PAH therapy. It also includes the number of events and patients for each treatment group (Orenitram and Placsbo) as well as a hazard ratio comparison between the two groups. The purpose and context of this table is not clear from the given text.*
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Principal Display Panel (0.125 mg Tablet Bottle Label)

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Principal Display Panel (0.125 mg Tablet Blister Pack Carton)

Principal Display Panel (0.125 mg Tablet Blister Pack Carton)
The text seems to be related to a medication in tablet form that contains treprostinildiolamine, with dosing information provided. The tablets need to be stored at 20-25°C (68-77°F) and are not child-proof, so they should be kept out of children's reach. Further instructions on swallowing the tablet whole and not splitting or crushing it are also provided. The text mentions that it should be accompanied by a patient information leaflet.*
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Principal Display Panel (0.25 mg Tablet Bottle Label)

Principal Display Panel (0.25 mg Tablet Bottle Label)
NDC 66302:302:01 is a medication with 100 tablets. It is advised to take the tablets with food according to the prescription. The medication's name is Orenitram (treprostinil) with EZ2X Extended-Release components in the tablets. Each tablet contains 0.25 mg of reprostinil dilamine equivalent to 0.25 ng of treprostinil. It is recommended not to split, chew, or crush the tablets. Additional literature for the medication is available.*
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Principal Display Panel (0.25 mg Tablet Blister Pack Carton)

Principal Display Panel (0.25 mg Tablet Blister Pack Carton)
This text is a description of a medication called Orenitram which comes in a 10-tablet blister pack. Each tablet contains 0.25mg of treprostinil diolamine. The medication should be taken with food as prescribed and should not be split, chewed, crushed, or broken. It should be stored at 20-25°C (68-77°F) with excursions permitted to 15-30°C (59-86°F). The accompanying literature should be consulted for dosing information. The medication should be kept out of reach of children and a child-resistant container should be used if it will be dispensed for outpatient use. The manufacturer is United Therapeutics Corp located in Research Triangle Park, NC.*
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Principal Display Panel (1 mg Tablet Bottle Label)

Principal Display Panel (1 mg Tablet Bottle Label)
NDC 66302:310-01 is a prescription drug in tablet form that contains treprostinil and is used for medical purposes. The recommended dosage and usage instructions are provided on the accompanying label. Each tablet contains treprostinil and must be swallowed whole without being chewed or broken.*
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Principal Display Panel (1 mg Tablet Blister Pack Carton)

Principal Display Panel (1 mg Tablet Blister Pack Carton)
This is a medication with extended-release tablets designed to be taken with food. Each tablet contains 1 mg of treprostinil and the patient information leaflet should be dispensed for each prescription. The literature accompanying the medication should be consulted for detailed dosing information. The medication should be kept out of reach of children and the tablets should be swallowed whole. The package is not child-resistant and should not be given to outpatients or children. The product is only available by prescription, with NDC code 66302-310-02.*
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Principal Display Panel (2.5 mg Tablet Bottle Label)

Principal Display Panel (2.5 mg Tablet Bottle Label)
Product: NDC 66302:325-01 - Orenitram (treprostinil) Tablets 2.5mg and 5mg Package: 100 Tablets in a bottle with child-resistant cap Storage: Store at 20-25°C (68-77°F), excursions permitted between 15-30°C (59-86°F). Also, see USP Controlled Room Temperature Dosage: Each tablet contains treprostinil diolamine equivalent to 2.5mg or 5mg of treprostinil. Swallow whole; do not crush or break tablets. Prescription: Rx only Safety: Keep out of reach of children.*
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Principal Display Panel (2.5 mg Tablet Blister Pack Carton)

Principal Display Panel (2.5 mg Tablet Blister Pack Carton)
This is a medication called Orenitram in its extended-release tablet form, manufactured by United Therapeutics Corp. Each tablet contains 2.5mg of the active ingredient Treprostinil. The medication should be taken as directed with food and stored at a controlled room temperature. This package contains ten tablets and is not child-resistant. It should be dispensed to the patient with the Patient Information Leaflet. The text also includes dosage and usage information but refers to accompanying literature for more detail.*
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Principal Display Panel (5 mg Tablet Bottle Label)

Principal Display Panel (5 mg Tablet Bottle Label)
This is a description of medication named Orenitram. It is taken orally and comes in tablet form with extended-release capabilities. Each tablet contains treprostinil dioamine equivalent. Patients are advised not to split, chew, crush or break the tablets and to swallow the whole tablet. It requires a prescription to obtain.*
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Principal Display Panel (5 mg Tablet Blister Pack Carton)

Principal Display Panel (5 mg Tablet Blister Pack Carton)
This is a medication for oral administration called Orenitram containing treprostinil diolamine, equivalent to 5mg of treprostinil per extended-release tablet. It should be taken with food exactly as prescribed, and the accompanying literature provides dosing information. It should be stored between 20-25°C (68-77°F), with excursions permitted to 15-30°C (59-86°F), while being kept out of reach from children. This unit-dose package is not child resistant, and a child-resistant container should be used for outpatient use. It comes in a 10-tablet blister pack and should be swallowed whole, not split, chewed, crushed or broken. The accompanying Patient Information Leaflet should be dispensed to each patient, and the tablets are manufactured by United Therapeutics Corp., Research Triangle Park, NC 27709.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.