Uptravi Tablet, Coated
Product Images NDC 66215-606

20 FDA label images from Actelion Pharmaceuticals Us, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 20 technical images submitted to the FDA as part of the official labeling for Uptravi (NDC 66215-606). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Actelion Pharmaceuticals Us, Inc., 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 (Uptravi 01)

Chemical Structure (Uptravi 01)
An instructional illustration showing hands opening a medication vial by lifting or peeling a protective cap. The image demonstrates the first step in accessing the vial contents safely for use.*
FDA Label Image

Figure 1 (Uptravi 02)

Figure 1 (Uptravi 02)
An instructional illustration showing hands peeling off a protective seal or cover from a container or bottle. The image focuses on the action of removing the seal, indicated by an arrow pointing upwards.*
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Figure 2 (Uptravi 03)

Figure 2 (Uptravi 03)
Chemical structure of Selexipag, the active ingredient in UPTRAVI tablets. The diagram shows the molecular arrangement with various rings and functional groups characteristic of Selexipag.*
FDA Label Image

Figure 3 A (Uptravi 04)

Figure 3 A (Uptravi 04)
A fold-change chart comparing pharmacokinetic interactions between Selexipag and its active metabolite with various interacting drugs, including gemfibrozil, clopidogrel, lopinavir/ritonavir, rifampin, warfarin, ERA, PDE-5 inhibitors, and their combinations. The chart displays fold-change on a logarithmic scale for parameters AUC and Cmax relative to Selexipag alone, with point estimates and 90% confidence intervals.*
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Figure 3b (Uptravi 05)

Figure 3b (Uptravi 05)
A chart showing fold-change data of UPTRAVI (selexipag) interacting with drugs warfarin (R-warfarin and S-warfarin) and midazolam (midazolam and 1-OH-midazolam). The graph presents point estimates and 90% confidence intervals for AUC and Cmax fold-changes relative to each drug alone on a logarithmic scale ranging from 0.5 to 2.*
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Figure 3 C (Uptravi 06)

Figure 3 C (Uptravi 06)
A Kaplan-Meier survival curve chart comparing UPTRAVI (Selexipag) patients to placebo patients over 36 months from randomization. The y-axis shows the percentage of patients event free, with UPTRAVI represented as a solid line and placebo as a dotted line. The graph includes hazard ratio, confidence interval, and p-value statistics, as well as the number of patients at risk at multiple time points.*
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Figure 4 (Uptravi 07)

Figure 4 (Uptravi 07)
A line graph comparing the estimated cumulative probability over 36 months from randomization between patients treated with UPTRAVI and placebo. The x-axis shows months from randomization, and the y-axis shows estimated cumulative probability in percentage. UPTRAVI patients are represented by a solid line, and placebo patients by a dotted line. Numbers of patients at risk are listed below the x-axis at various time points for both groups.*
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Principal Display Panel (200 mcg Tablet Bottle Carton)

Principal Display Panel (200 mcg Tablet Bottle Carton)
A Kaplan-Meier curve showing estimated cumulative probability over months from randomization, comparing UPTRAVI (solid line) with placebo (dotted line). The graph includes the number of patients at risk over time for each group, demonstrating event probabilities up to 36 months.*
FDA Label Image

Principal Display Panel (400 mcg Tablet Bottle Carton)

Principal Display Panel (400 mcg Tablet Bottle Carton)
A line graph showing the estimated cumulative probability (%) over 36 months from randomization, comparing patients treated with UPTRAVI (Selexipag) to those receiving placebo. The graph includes the number of patients at risk for each group at different time points below the x-axis timeline. UPTRAVI is represented by a solid line and placebo by a dotted line.*
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Principal Display Panel (600 mcg Tablet Bottle Carton)

Principal Display Panel (600 mcg Tablet Bottle Carton)
A forest plot chart showing hazard ratios and 99% confidence intervals for various subgroups related to treatment effects of UPTRAVI (Selexipag). The chart compares treatment effect across factors like PAH therapy at baseline, WHO functional class, sex, race, age, PAH etiology, and geographical region, with data points indicating whether effects favor UPTRAVI or placebo.*
FDA Label Image

Principal Display Panel (800 mcg Tablet Bottle Carton)

Principal Display Panel (800 mcg Tablet Bottle Carton)
Packaging label for Uptravi (selexipag) 200 mcg film-coated tablets, with 60 tablets per container. The label shows the proprietary and generic names, strength, dosage form, and that it is for prescription use only. It includes storage instructions, manufacturer information (Actelion Pharmaceuticals US, Inc. and Janssen), barcode, and dosage information.*
FDA Label Image

Principal Display Panel (1000 mcg Tablet Bottle Carton)

Principal Display Panel (1000 mcg Tablet Bottle Carton)
Packaging label for Uptravi (selexipag) 400 mcg film-coated tablets. The carton contains 60 tablets and is labeled as Rx only. The label shows the product name, strength, dosage form, and storage instructions. Manufactured for Actelion Pharmaceuticals US, Inc., a Janssen Pharmaceutical Company.*
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Principal Display Panel (1200 mcg Tablet Bottle Carton)

Principal Display Panel (1200 mcg Tablet Bottle Carton)
Packaging label for Uptravi (selexipag) 600 mcg film-coated tablets by Actelion Pharmaceuticals US, Inc. The label shows 60 tablets per package and indicates storage instructions between 20°C to 25°C with permitted excursions. It includes barcode, manufacturer information, and dosage form details.*
FDA Label Image

Principal Display Panel (1400 mcg Tablet Bottle Carton)

Principal Display Panel (1400 mcg Tablet Bottle Carton)
Packaging label for Uptravi (selexipag) 800 mcg film-coated tablets. The carton indicates 60 tablets per package and is labeled for prescription use only. Manufactured by Actelion Pharmaceuticals US, Inc., a Janssen Pharmaceutical Company, with storage instructions and barcode details visible. The label emphasizes reading the prescribing information before use.*
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Principal Display Panel (1600 mcg Tablet Bottle Carton)

Principal Display Panel (1600 mcg Tablet Bottle Carton)
Packaging label for Uptravi (selexipag) tablets, 1000 mcg strength. The label indicates 60 film-coated tablets per bottle. It includes storage instructions, usage warnings, NDC number 66215-610-06, and manufacturer details for Actelion Pharmaceuticals US, Inc. The label design features green and orange accents with the Janssen logo.*
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Principal Display Panel (Kit Carton)

Principal Display Panel (Kit Carton)
Packaging label for Uptravi (selexipag) 1200 mcg coated tablets. The label indicates a prescription-only medication with a package count of 60 film-coated tablets. The label includes storage instructions, barcode, manufacturer details indicating it is made in the UK by Actelion Pharmaceuticals US, Inc., a Janssen Pharmaceutical Company, and a web address for patent information.*
FDA Label Image

Uptravi 17

Uptravi 17
Box packaging label for Uptravi (selexipag) 1400 mcg film-coated tablets. The label indicates prescription use only, with 60 tablets per container. Manufactured for Actelion Pharmaceuticals US, Inc., a Janssen Pharmaceutical Company. Storage information, lot number, and expiration date details are also present on the label.*
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Uptravi 18

Uptravi 18
Packaging label for Uptravi (selexipag) tablets, 1600 mcg strength. The label indicates the product contains 60 film-coated tablets for oral use. It is marked as Rx only and manufactured by Janssen, a subsidiary of Actelion Pharmaceuticals US, Inc. Storage instructions and a barcode are also visible on the label.*
FDA Label Image

Uptravi 19

Uptravi 19
Packaging label for Uptravi (selexipag) tablets oral dosage form, a human prescription drug by Actelion Pharmaceuticals US, Inc. This titration pack contains 200 mcg and 800 mcg strengths of film-coated tablets. The pack includes a 140-count bottle of 200 mcg tablets and a 60-count bottle of 800 mcg tablets. Label states storage conditions and manufacturer information.*
FDA Label Image

Uptravi 20

Uptravi 20
Packaging label for UPTRAVI (selexipag) for injection, 1,800 mcg per vial, by Actelion Pharmaceuticals US, Inc. The label indicates the product is for intravenous infusion only and must be reconstituted and diluted prior to use. It specifies single-dose vial usage with disposal instructions for unused portions, storage requirements at 2°C to 8°C, and lists inactive ingredients. The label includes manufacturer details and barcode.*

* 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.