Adempas Tablet, Film Coated
Product Images NDC 50419-253

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Adempas (NDC 50419-253). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Bayer Healthcare Pharmaceuticals 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.

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Chemical Structure (E9e1a668 1b31 4094 88b7 2004f94af53d 01)

Chemical structure of riociguat, the active ingredient in Adempas. The diagram shows the molecular arrangement of atoms and bonds specific to riociguat.*

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Effect Of Intrinsic Factors On Riociguat And M1 Pharmacokinetics (E9e1a668 1b31 4094 88b7 2004f94af53d 02)

A forest plot chart depicting the pharmacokinetic point estimates and 90% confidence intervals for riociguat and its metabolite M1. It compares changes due to hepatic impairment, renal impairment, age, and gender, showing values for AUC and Cmax relative to reference groups.*

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Figure 2: Effect Of Extrinsic Factors On Riociguat And M1 Pharmacokinetics (E9e1a668 1b31 4094 88b7 2004f94af53d 03)

A pharmacokinetic chart showing the effects of various substances on the exposure levels of riociguat and its metabolite M1. The graph plots point estimates with 90% confidence intervals of AUC and Cmax changes relative to reference for inhibitors, inducers, antacids, antiplatelet agents, anticoagulants, and smoking, with dosing recommendations summarized on the right side.*

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Chest-1 Mean Change From Baseline In The 6-minute Walk (E9e1a668 1b31 4094 88b7 2004f94af53d 04)

A line graph comparing the change from baseline to last visit in 6-minute walk distance (meters) over 16 weeks between Adempas and placebo groups. The x-axis represents weeks from baseline to 16, and the y-axis measures change in walk distance. Adempas shows a consistent increase, while placebo shows a smaller, fluctuating increase followed by a decline.*

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Figure 5: Mean Treatment Difference In Change From Baseline To Last Visit In 6-minute Walk Distance (meters) By Prespecified Subgroups (E9e1a668 1b31 4094 88b7 2004f94af53d 06)

A forest plot comparing the mean change in 6-minute walk distance (6MWD) between placebo and Adempas groups across different patient subpopulations, including inoperable CTEPH, postoperative CTEPH, and WHO functional classes. The plot shows least squares differences with 95% confidence intervals favoring Adempas in most comparisons.*

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Patent-1 Mean Change From Baseline In The 6-minute Walk Distance (E9e1a668 1b31 4094 88b7 2004f94af53d 07)

A line graph comparing change from baseline to last visit in 6-minute walk distance (in meters) over 12 weeks between Adempas and placebo groups. The graph shows Adempas group with a steady increase, reaching nearly 35 meters improvement, while placebo shows a smaller peak around 25 meters at 8 weeks then declines.*

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Patent-1 Distribution Of Patients By Change From Baseline In 6-minute Walk Distan (E9e1a668 1b31 4094 88b7 2004f94af53d 08)

A histogram chart depicting the percentage of patients experiencing change from baseline to last visit in 6-minute walk distance (meters) for Adempas versus placebo. The x-axis represents the change distance from worsening (negative values) to improvement (positive values), and the y-axis shows the percentage of patients. The data compare Adempas (black bars) and placebo (white bars) across various distance intervals.*

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Patent-1 Mean Treatment Difference In Change From Baseline To Last Visit In 6-minute Walk Distance (meter) By Prespecified Subgroups (E9e1a668 1b31 4094 88b7 2004f94af53d 09)

A forest plot chart showing the least squares mean differences in 6-minute walking distance (6MWD) change between placebo and Adempas (riociguat) across various patient subgroups. The chart includes patient counts, mean changes in 6MWD for placebo and Adempas groups, and confidence intervals for the difference in means, indicating the efficacy of Adempas in improving 6MWD relative to placebo.*

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Patent-1 Time (in Days) To Clinical Worsening (itt Analysis Set) (E9e1a668 1b31 4094 88b7 2004f94af53d 10)

A line graph depicting the percentage of patients with disease progression over time (days) comparing Adempas (riociguat) and placebo. The y-axis shows the percentage, and the x-axis shows days up to 84. The Adempas group has a consistently lower percentage of progression than the placebo group, which increases more steeply.*

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Birth Control Methods (E9e1a668 1b31 4094 88b7 2004f94af53d 11)

An illustration showing four acceptable birth control options presented in four separate columns. Each option outlines different combinations of contraceptive methods such as intrauterine devices, hormonal contraceptives, barrier methods like diaphragms and male condoms, partner's vasectomy, and other hormonal methods. The content provides guidance on selecting contraceptive methods in combination for effectiveness.*

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.5 Carton (E9e1a668 1b31 4094 88b7 2004f94af53d 12)

Packaging label for Adempas (riociguat) tablets, 0.5 mg per tablet, film-coated oral tablets by Bayer HealthCare Pharmaceuticals Inc. The label includes dosage strength, quantity of 90 tablets, NDC 50419-250-01, storage instructions, a barcode, and manufacturer information showing production in Germany. The label highlights that the product is prescription only.*

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1 Carton (E9e1a668 1b31 4094 88b7 2004f94af53d 13)

Packaging label for Adempas (riociguat) tablets, 1 mg per tablet, film-coated oral tablets. The label indicates a 90 tablet count per bottle and includes storage instructions, dosage form, and barcode. Manufactured by Bayer HealthCare Pharmaceuticals Inc.*

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1.5 Carton (E9e1a668 1b31 4094 88b7 2004f94af53d 14)

Packaging label for Adempas (riociguat) tablets 1.5 mg, film-coated oral tablets. The label indicates a bottle containing 90 tablets. Manufacturer is Bayer HealthCare Pharmaceuticals Inc. The label includes dosage, storage, and dispensing instructions. The design features orange and blue accents with a barcode and NDC numbers visible.*

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2 Carton (E9e1a668 1b31 4094 88b7 2004f94af53d 15)

Packaging label for Adempas (riociguat) tablets, 2 mg per tablet, film-coated oral tablets. The carton contains 90 film-coated tablets. The label includes manufacturer information for Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ, with manufacturing in Germany. The package features dosing advisory, storage instructions, a barcode, and a note to dispenser to provide a Medication Guide to the patient.*

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2.5 Carton (E9e1a668 1b31 4094 88b7 2004f94af53d 16)

Adempas (riociguat) tablets packaging label for the 2.5 mg strength. The label indicates 90 film-coated tablets per bottle. Manufacturer is Bayer HealthCare Pharmaceuticals Inc. The label includes storage instructions, a barcode, and directions to provide a medication guide with each patient and refill. The design features orange and purple highlights with Bayer branding.*

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Figure 4: Chest-1 Distribution Of Patients By Change From Baseline In 6-minute Walk Distance (Image 01)

A bar graph comparing the percentage of patients experiencing changes in 6-minute walk distance from baseline to the last visit between Adempas (riociguat) and placebo groups. The x-axis shows changes in meters ranging from worsening to improvement, while the y-axis shows the percentage of patients. The graph visually contrasts patient outcomes for Adempas versus placebo.*

* 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.