Xeloda
Product Images NDC 54868-4143

9 FDA label images from Physicians Total Care, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Xeloda (NDC 54868-4143). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Physicians Total Care, 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

Principal Display Panel (150 mg Tablet Bottle Label)

Principal Display Panel (150 mg Tablet Bottle Label)
Packaging label for Xeloda 150 mg tablets showing the labeler as Physicians Total Care, Inc. The label includes an NDC number (54368-4143-0), a count of 60 tablets, a lot number placeholder, and an expiration date placeholder. The manufacturer is Hoffmann-La Roche Inc., Nutley, NJ. A barcode and numeric code are present at the bottom.*
FDA Label Image

Principal Display Panel (500 mg Tablet Bottle Label)

Principal Display Panel (500 mg Tablet Bottle Label)
Xeloda 500 mg tablets label by Physicians Total Care, Inc. The label states the active ingredient capecitabine and indicates a total of 30 tablets per container. It includes cautionary information regarding federal law, dosage instructions, lot number, expiration date, and storage conditions. A barcode is visible on the right side of the label.*
FDA Label Image

Chemical Structure (Xeloda 01)

Chemical Structure (Xeloda 01)
Chemical structure diagram of the active ingredient in Xeloda, showing a fluorinated pyrimidine derivative with sugar moiety and ester functional groups.*
FDA Label Image

Chemical Structure (Xeloda 02)

Chemical Structure (Xeloda 02)
An enzymatic pathway diagram showing the conversion of Capecitabine to active metabolites. Capecitabine converts to 5'-DFCR via Carboxylesterase, then to 5'-DFUR via Cyd deaminase, and finally to 5-FU via dThdPase.*
FDA Label Image

Figure 1 (Xeloda 03)

Figure 1 (Xeloda 03)
Kaplan-Meier survival curve comparing two treatment groups: 5-FU + Leucovorin and Capecitabine, over months since randomization. The vertical axis shows survival probability, ranging from 0 to 1, and the horizontal axis displays time in months up to 96. Number of patients at risk for each group is listed below the graph at multiple time points.*
FDA Label Image

Figure 2 (Xeloda 04)

Figure 2 (Xeloda 04)
A survival curve graph comparing two treatment groups: 5-FU + Leucovorin (dashed line) and Capecitabine (solid line). The x-axis represents months since randomization, ranging from 0 to 96. The y-axis shows survival probability from 0.0 to 1.0. Below the graph, the number of patients at risk is listed over time for each group.*
FDA Label Image

Figure 3 (Xeloda 05)

Figure 3 (Xeloda 05)
A survival curve graph comparing estimated probability over time (days) between two treatment groups: 5-FU plus Leucovorin (Mayo Regimen) and Xeloda 1250 mg/sqm twice daily intermittent. The graph displays declining survival probabilities up to approximately 1500 days.*
FDA Label Image

Figure 4 (Xeloda 06)

Figure 4 (Xeloda 06)
A Kaplan-Meier survival curve comparing two groups: one treated with Docetaxel 100 mg/sqm every 3 weeks and the other with Xeloda 1250 mg/sqm twice daily intermittently combined with Docetaxel 75 mg/sqm every 3 weeks. The graph shows estimated probability on the vertical axis and time in days on the horizontal axis, illustrating survival over approximately 800 days.*
FDA Label Image

Figure 5 (Xeloda 07)

Figure 5 (Xeloda 07)
A survival probability Kaplan-Meier curve comparing two groups: Docetaxel 100 mg/sqm every 3 weeks and Xeloda 1250 mg/sqm twice daily intermittently with docetaxel 75 mg/sqm every 3 weeks. The y-axis shows estimated survival probability from 0 to 1, and the x-axis shows time in days up to 800, with notable median survival points marked at approximately 351 and 442 days for the respective groups.*

* 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.