Bylvay Capsule, Coated Pellets
Product Images NDC 15054-3301

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Bylvay (NDC 15054-3301). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Ipsen Biopharmaceuticals, 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 (Bylvay 01)

Chemical structure of odevixibat dihydrate, the active ingredient in Bylvay capsules, showing its detailed molecular arrangement including functional groups and the 1.5 molecules of water of hydration.*

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Figure 1 (Bylvay 02)

A line graph showing scratching scores over six months for three groups: placebo, odevixibat 40 mcg/kg/day, and odevixibat 120 mcg/kg/day. The placebo group shows a relatively stable, higher score, while both odevixibat groups show a notable decrease in scratching scores over time with similar trends.*

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Figure 2 (Bylvay 03)

A line graph comparing scratching scores over six months between a placebo group and a group receiving odevixibat at 120 µg/kg/day. The vertical axis shows scratching scores from 0 to 4, and the horizontal axis shows time in months from 0 to 6. The graph illustrates a decrease in scratching scores over time in both groups, with the odevixibat group showing a more pronounced reduction than the placebo group.*

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Figure A (Bylvay 04)

Illustration showing a pair of hands holding a capsule labeled with directional arrows, positioned above a container or surface, likely demonstrating how to open or handle the capsule for oral administration.*

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Figure B (Bylvay 05)

An instructional illustration showing hands opening a capsule and emptying its contents into a small container or bowl. The image demonstrates how to prepare the contents of an oral capsule, which corresponds to the oral dosage form of the drug Bylvay (odevixibat).*

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Figure C (Bylvay 06)

An instructional illustration showing a capsule being opened with both hands. The capsule halves are separated, and small granules are released onto a flat surface below. The image demonstrates how to open a capsule and empty its contents.*

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Figure D (Bylvay 07)

An instructional illustration showing a hand holding a spoon and stirring its contents in a bowl with a circular arrow indicating a stirring motion.*

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Figure E (Bylvay 08)

An instructional illustration showing two hands opening a capsule with twisting motions, releasing the contents into a small glass below. This suggests the capsule contents can be emptied into a drink for oral administration.*

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Figure F (Bylvay 09)

An instructional illustration showing a hand pricking a finger with a lancet to obtain a blood drop, which is directed towards a small container or cup below. The image depicts a blood sample collection procedure.*

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Figure G (Bylvay 10)

An instructional illustration showing a person administering oral medication to a baby or young child using an oral syringe placed inside the child's mouth. The illustration depicts hand positioning for proper delivery of liquid medicine by mouth.*

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Principal Display Panel (200 mcg Capsule Bottle Carton)

Packaging label for Bylvay 200 mcg oral pellets capsules. The carton indicates the generic name odevixibat, contains 30 capsules, and is labeled for prescription use only. Manufactured and distributed by Ipsen Biopharmaceuticals, Inc., with origin stated as India. Storage instructions and a barcode are also visible on the label.*

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Principal Display Panel (400 mcg Capsule Bottle Carton)

Packaging label for Bylvay 400 mcg capsules, containing odevixibat, distributed by Ipsen Biopharmaceuticals, Inc. The label indicates 30 capsules per package, with storage instructions and a barcode. The product is prescription only and manufactured in India.*

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Principal Display Panel (600 mcg Capsule Bottle Carton)

Box packaging for Bylvay 600 mcg oral pellets capsules by Ipsen Biopharmaceuticals, Inc. The label includes the proprietary name Bylvay with the generic name odevixibat, strength of 600 mcg, and contains 30 capsules. Storage instructions and manufacturer location (India) are also printed on the label along with a barcode and NDC number 15054-3303-1.*

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Principal Display Panel (1,200 mcg Capsule Bottle Carton)

Box packaging label for Bylvay (odevixibat) capsules, 1,200 mcg strength. The label shows the product name, strength, dosage form as capsules, and a count of 30 capsules. Ipsen Biopharmaceuticals, Inc. is listed as the manufacturer and distributor. Storage instructions at 20°C to 25°C and a note to see prescribing information for dosage are included. The label also features barcodes and the Ipsen logo.*

* 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.