Xromi Solution
Product Images NDC 62484-0015

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Xromi (NDC 62484-0015). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Nova Laboratories, Ltd., 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 (Xromi 01)

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Picture Of Bottle And Oral Dispensing Syringes (Xromi 02)

Picture Of Bottle And Oral Dispensing Syringes (Xromi 02)
This is information about a bottle adaptor used with two syringes - a white syringe for doses more than 3 mL and a red syringe for doses of 3 mL or less. The marking on the adaptor indicates the oral dosing levels of 12 mL and 3 mL.*
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Figure A (Xromi 03)

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Figure B (Xromi 04)

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Figure C (Xromi 05)

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Figure D (Xromi 06)

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Figure E (Xromi 07)

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Figure F (Xromi 08)

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Figure G (Xromi 09)

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Figure H (Xromi 10)

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Figure I (Xromi 11)

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Figure J (Xromi 12)

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Xromi Bottle Label (Xromi Bottle Label)

Xromi Bottle Label (Xromi Bottle Label)
The text provides essential information about a medication called "Xromi" (hydroxyurea) in oral solution form with a concentration of 100 mg/mL. It includes details such as inactive ingredients, manufacturer, distributor, dosage instructions, storage conditions, and precautions. The medication is indicated for rare diseases and comes in 180 mL bottles. It is necessary to refrigerate the medication and not shake it before use. Additionally, the accompanying Medication Guide should be provided to each patient, and any unused portion should be discarded after 12 weeks from the first opening.*
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Xromi Carton Label (Xromi Carton Label)

Xromi Carton Label (Xromi Carton Label)
This is a description for Xromi, an oral solution containing 100 mg/mL of hydroxyurea. It is recommended for oral use only, with a warning that it is a hazardous drug and should not be shaken. The product is manufactured by Nova Laboratories Ltd in the United Kingdom and is intended for Rare Disease Therapeutics, Inc. in Tennessee. The solution comes in a 150 mL glass bottle and includes bottle adapters and oral dosing syringes. It also contains inactive ingredients such as methyl parahydroxybenzoate, purified water, and strawberry flavor. The Braille information provided on the packaging includes warnings and dosage instructions for patient safety.*

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