Ganciclovir Injection, Powder, Lyophilized, For Solution
Product Images NDC 63323-315

8 FDA label images from Fresenius Kabi Usa, Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Ganciclovir (NDC 63323-315). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Fresenius Kabi Usa, Llc, 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

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Chemical structure of ganciclovir sodium displaying the molecular formula C9H12N5NaO4 and molecular weight of 277.22. The diagram shows the molecular arrangement of atoms in ganciclovir sodium, an antiviral agent.*
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Chemical structure diagram of ganciclovir showing its molecular formula C9H13N5O4 and molecular weight 255.23.*
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A line graph titled 'ICM 1653: Time to Progression of CMV Retinitis' depicting the proportion of patients without progression over time in days from the start of maintenance therapy. Two lines compare intravenous (IV) and oral treatments, showing decreasing proportions of patients without progression over approximately 150 days.*
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A line graph titled 'ICM 1774: Time to Progression of CMV Retinitis' showing proportion without progression over time from start of maintenance therapy in days, comparing intravenous (IV) and oral administration. The vertical axis represents proportion without progression ranging from 0 to 1, and the horizontal axis shows time intervals up to 120 days. The IV group is represented by a dashed line, and oral by a solid line, with the IV group showing a higher proportion without progression over time.*
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A line graph titled 'AVI 034: Time to Progression of CMV Retinitis' comparing the proportion of patients without progression over time from the start of maintenance therapy in days. It shows two lines representing intravenous (IV) and oral administration, with the x-axis labeled as time in days (0 to 150) and the y-axis as proportion without progression (0 to 1). The IV line is dashed, and the oral line is solid.*
FDA Label Image

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Ganciclovir 500 mg per vial injection, powder, lyophilized, for intravenous infusion only. The label states it is a potent cytotoxic agent and suspected carcinogen, with handling cautions. Manufactured by Fresenius Kabi USA, LLC. The vial is sterile and requires reconstitution prior to administration. The label includes NDC 63323-315-41 and barcode.*
FDA Label Image

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Label for Ganciclovir injection, lyophilized powder for solution, 500 mg per vial, by Fresenius Kabi USA, LLC. It is for intravenous infusion only, supplied as 25 vials of 10 mL each. The label includes a warning that it is a potent cytotoxic agent and suspected carcinogen. Storage and preparation instructions are also provided.*

* 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.