Capecitabine Tablet, Film Coated
Product Images NDC 16729-072

9 FDA label images from Accord Healthcare 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 Capecitabine (NDC 16729-072). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Accord Healthcare 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 (Capecitabine 150 Label)

Principal Display Panel (Capecitabine 150 Label)
Capecitabine 150 mg tablets USP film-coated oral dosage form by Accord Healthcare Inc. The label specifies each tablet contains 150 mg of capecitabine. The package contains 60 tablets. It includes storage instructions, dosage warnings, and barcodes. Manufactured by Intas Pharmaceuticals Limited, India.*
FDA Label Image

Principal Display Panel (Capecitabine 500 Label)

Principal Display Panel (Capecitabine 500 Label)
Label for Capecitabine Tablets USP 500 mg, film coated oral tablets. The label includes dosage strength, manufacturer Accord Healthcare Inc., and instructions for storage, handling, and dispensing. Package contains 120 tablets. Manufactured by Intas Pharmaceuticals Limited, India. The label also indicates the drug is cytotoxic and prescription only (Rx Only).*
FDA Label Image

Figure 1 (Capecitabine Fig1)

Figure 1 (Capecitabine Fig1)
A survival curve graph comparing treatment groups of Capecitabine and 5-FU plus Leucovorin. The x-axis represents months since randomization, and the y-axis shows survival proportion. Two lines, one solid for Capecitabine and one dashed for 5-FU plus Leucovorin, depict survival over time with corresponding patient counts at risk below the x-axis.*
FDA Label Image

Figure 2 (Capecitabine Fig2)

Figure 2 (Capecitabine Fig2)
A survival curve chart comparing two treatment groups: 5-FU + Leucovorin (dashed line) and Capecitabine (solid line). The x-axis represents months since randomization up to 96 months, and the y-axis represents survival probability from 0.0 to 1.0. At the bottom, the number of patients at risk for each group is listed at various time points.*
FDA Label Image

Figure 3 (Capecitabine Fig3)

Figure 3 (Capecitabine Fig3)
Kaplan-Meier survival curve comparing estimated probability over time (days) between two groups: 5-FU plus Leucovorin (Mayo Regimen) and Capecitabine 1250 mg/sqm twice daily intermittent dosing. The graph shows probability estimates from 0 to about 1500 days with both groups' survival probabilities declining over time.*
FDA Label Image

Figure 4 (Capecitabine Fig4)

Figure 4 (Capecitabine Fig4)
A Kaplan-Meier survival curve depicting estimated probability over time (days) comparing two treatment groups: Docetaxel 100 mg/sqm every 3 weeks (dashed line) and Capecitabine 1250 mg/sqm twice daily intermittently combined with Docetaxel 75 mg/sqm every 3 weeks (solid line). The graph shows survival probability declining over approximately 700 days for both groups, with marked time points at 128 and 186 days.*
FDA Label Image

Figure 5 (Capecitabine Fig5)

Figure 5 (Capecitabine Fig5)
A Kaplan-Meier survival curve chart showing estimated probability over time in days. It compares two groups: Docetaxel 100 mg/sqm every 3 weeks (dashed line) and Capecitabine 1250 mg/sqm twice daily intermittently with Docetaxel 75 mg/sqm every 3 weeks (solid line). Median survival times are indicated at 351.5 and 442.0 days.*
FDA Label Image

Chemical Structure (Capecitabine Met Path)

Chemical Structure (Capecitabine Met Path)
An illustration diagram showing the metabolic pathway of Capecitabine, highlighting chemical structures of Capecitabine, 5'-DFCR, 5'-DFUR, and 5-FU and enzymes involved such as Carboxylesterase, Cyd deaminase, and dThdPase.*
FDA Label Image

Chemical Structure (Capecitabine Str)

Chemical Structure (Capecitabine Str)
Chemical structure of capecitabine, showing its molecular components and bonds, consistent with the active ingredient capecitabine.*

* 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.