Hercessi Injection, Powder, Lyophilized, For Solution
Product Images NDC 69448-016

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Hercessi (NDC 69448-016). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Accord Biopharma 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

Figure 1 (Hercessi 01)

A line graph showing cumulative incidence over time in years from initiation of Paclitaxel/Herceptin. The x-axis represents time from 0 to 9 years, and the y-axis shows cumulative incidence from 0 to 0.5. Two lines are plotted, labeled AC->T+H and AC->T, with accompanying confidence intervals shaded around each line. The graph includes numbers at risk for both groups at various time points along the x-axis.*

FDA Label Image

Figure 2 (Hercessi 02)

A cumulative incidence chart comparing trastuzumab 1-year treatment versus observation only over 24 months from randomization. The x-axis shows time in months, and the y-axis shows cumulative incidence rates. The graph includes lines for trastuzumab 1-year and observation only groups, with numbers at risk displayed at intervals below the x-axis.*

FDA Label Image

Figure 3 (Hercessi 03)

A cumulative incidence line chart showing three treatment regimens over time in months up to 36 months. The x-axis represents time in months, and the y-axis shows cumulative incidence. The three plotted regimens are AC->T (doxorubicin + cyclophosphamide followed by docetaxel), AC->TH (doxorubicin + cyclophosphamide followed by docetaxel and trastuzumab), and TCH (docetaxel, carboplatin, and trastuzumab). A table below the chart lists the number of patients at risk at various time points for each regimen.*

FDA Label Image

Figure 4 (Hercessi 04)

A Kaplan-Meier survival curve chart depicting disease-free survival over 3.5 years, comparing two chemotherapy regimens: AC->TH (doxorubicin + cyclophosphamide followed by paclitaxel and trastuzumab) shown by a dashed line, and AC->T (doxorubicin + cyclophosphamide followed by paclitaxel) shown by a solid line. The y-axis shows the proportion event-free, and the x-axis shows years of disease-free survival. The number of patients at risk is listed below the x-axis for each time point.*

FDA Label Image

Figure 5 (Hercessi 05)

A Kaplan-Meier survival curve chart depicting overall survival in years versus proportion alive. The chart compares two treatment groups: AC->T (doxorubicin + cyclophosphamide followed by paclitaxel) shown as a solid line, and AC->T+H (doxorubicin + cyclophosphamide followed by paclitaxel plus trastuzumab) shown as a dashed line. Accompanying tables indicate numbers at risk at various time points up to 11 years.*

FDA Label Image

Figure 6 (Hercessi 06)

A Kaplan-Meier survival curve chart depicting disease-free survival over 5 years. The graph compares three treatment regimens involving doxorubicin, cyclophosphamide, docetaxel, carboplatin, and trastuzumab, showing the proportion of patients event-free on the vertical axis and disease-free survival time in years on the horizontal axis. Number at risk is also detailed below the chart.*

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Figure 7 (Hercessi 07)

A Kaplan-Meier survival curve chart titled 'Product-Limit Survival Estimates with Number of Subjects at Risk,' showing survival probability over duration in months. It compares two treatment groups: Fluoropyrimidine plus Cisplatin versus Fluoropyrimidine plus Cisplatin plus Trastuzumab (trastuzumab is the active ingredient in Hercessi). The chart includes censored data points and displays the number of subjects at risk at various time intervals up to 50 months.*

FDA Label Image

Principal Display Panel (150 mg Vial Carton)

Label for HERCESSI (trastuzumab-strf) injection, containing 150 mg per vial as a single-dose lyophilized powder for intravenous infusion. Manufacturer is Accord BioPharma Inc. Storage instructions include refrigeration at 2°C to 8°C and protection from light. Label includes barcode, NDC 69448-015-05, and handling instructions such as discarding unused solution, avoiding freezing and shaking after reconstitution.*

FDA Label Image

Principal Display Panel (150 mg Vial Carton)

HERCESSI 150 mg per vial injection, lyophilized powder for intravenous use. The carton label shows the product name with the generic name trastuzumab-strf, dosage strength, single-dose vial designation, storage instructions, and manufacturer Accord BioPharma Inc. It includes handling instructions such as reconstitution and storage temperature (2°C to 8°C). The label features orange and pink accents on a white background with manufacturer details and a barcode.*

FDA Label Image

Principal Display Panel (420 mg Vial Carton)

HERCESSI 420 mg per vial packaging label for trastuzumab-strf injection, powder, lyophilized, for intravenous use. The multiple-dose vial is labeled with usage instructions, storage requirements, and manufacturer information for Accord BioPharma Inc. The label highlights that the vial contains 420 mg of the active ingredient and is presented in a white and purple color scheme with Accord BioPharma branding.*

FDA Label Image

Principal Display Panel (420 mg Vial Carton)

Label of HERCESSI (trastuzumab-strf) injection, powder, lyophilized for solution, showing 420 mg per vial strength. The label states it is a multiple-dose vial for intravenous use. It includes storage instructions, reconstitution guidance, and manufacturer Accord BioPharma Inc. The label also displays the NDC 69448-016-11 and the US license number.*

* 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.