Orladeyo Pellet
Product Images NDC 72769-111

Product Visual Gallery

This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Orladeyo (NDC 72769-111). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Biocryst 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.

FDA Label Image

Chemical Structure (Orladeyo 01)

Chemical structure diagram of berotralstat hydrochloride, the active ingredient in Orladeyo capsules, showing molecular bonds and atomic groups including fluorine, cyano, and trifluoromethyl substituents.*

FDA Label Image

Figure 1 (Orladeyo 02)

A chart titled 'Recommendation' showing geometric mean ratios and 90% confidence intervals for various CYP substrates and transporters interacting with Orladeyo. It compares AUC and Cmax values for drugs metabolized by CYP3A4, CYP2D6, CYP2C9, CYP2C19, P-gp, and BCRP, with corresponding dosing recommendations. The bottom note specifies Orladeyo dosages used in digoxin and rosuvastatin studies.*

FDA Label Image

Figure 2 (Orladeyo 03)

A line graph showing mean investigator-confirmed attack rates per month over six months for Orladeyo capsules at 110 mg and 150 mg doses compared to placebo. The x-axis represents time in months from baseline to six months, and the y-axis indicates attack rates. Data points include error bars reflecting SEM. Orladeyo 150 mg shows the lowest attack rates, followed by 110 mg, with placebo having the highest rates throughout the period.*

FDA Label Image

Principal Display Panel (150 mg Capsule Blister Card Shellpack Carton)

Packaging label for Orladeyo 150 mg capsules (berotralstat), an oral prescription drug. The label states it contains 28 capsules, a 28-day supply divided into 4 shellpacks each with a 7-capsule blister card. The labeler is BioCryst Pharmaceuticals, Inc. The label includes the NDC 72769-101-01 and relevant usage information.*

FDA Label Image

Principal Display Panel (110 mg Capsule Blister Card Shellpack Carton)

Packaging label for Orladeyo capsules 110 mg by BioCryst Pharmaceuticals, Inc. The box contains 28 oral capsules supplied as 4 shellpacks, each with a 7-capsule blister card. The label indicates prescription use only and displays the NDC 72769-102-01 along with manufacturer and contact information.*

* 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.