Bortezomib Injection, Powder, Lyophilized, For Solution
Product Images NDC 63323-821

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

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Bortezomib (NDC 63323-821). 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

Bor00 0005 01

Bor00 0005 01
Chemical structure of Bortezomib, showing its molecular framework including boron-containing moiety linked to a peptide-like backbone with aromatic and nitrogen heterocyclic components.*
FDA Label Image

Bor00 0005 02

Bor00 0005 02
A Kaplan-Meier survival curve chart illustrating the percentage of patients over time in months. Two treatment groups are compared: Vc-MP (red line) and MP (blue dashed line). The chart includes a table of the number of patients at risk for each group at various time points and a p-value indicating statistical significance.*
FDA Label Image

Bor00 0005 03

Bor00 0005 03
A line chart depicting the percentage of patients over time (in months) comparing two treatment groups labeled Vc-MP and MP. The x-axis represents time in months up to 78, and the y-axis shows the percentage of patients from 0 to 100. The chart includes patient numbers at risk at various time points and notes a statistically significant difference with a p-value less than 0.05.*
FDA Label Image

Bor00 0005 04

Bor00 0005 04
A Kaplan-Meier curve chart comparing time to progression in patients treated with Bortezomib versus Dexamethasone in a relapsed multiple myeloma study. The y-axis shows the proportion of patients, and the x-axis shows time in days up to 480. Two survival curves are plotted, with Bortezomib showing a higher proportion of patients without progression over time compared to Dexamethasone. Patient numbers at risk and statistical significance (p<0.0001) are also noted.*
FDA Label Image

Bor00 0005 05

Bor00 0005 05
A line graph titled 'Figure 4: Overall Survival Bortezomib versus Dexamethasone (relapsed multiple myeloma study)' showing the proportion of patients over time (days). Two lines compare overall survival for Bortezomib and Dexamethasone, with Bortezomib maintaining a higher survival proportion throughout the study period up to 450 days. Patient counts at various time points are indicated along the x-axis.*
FDA Label Image

Bor00 0005 06

Bor00 0005 06
A survival curve chart comparing the percentage of patients over time (months) for two treatment groups labeled VcR-CAP and R-CHOP. The chart includes a log-rank test p-value of less than 0.001 and a table showing the number of subjects at risk at various time points for each group.*
FDA Label Image

Bor00 0005 07

Bor00 0005 07
A Kaplan-Meier survival curve graph depicting the percentage of subjects alive over months from randomization for two treatment groups labeled VcR-CAP and R-CHOP. The solid line represents VcR-CAP and the dashed line represents R-CHOP. The graph includes a hazard ratio with 95% confidence interval and shows the number of subjects at risk for each group at various time points.*
FDA Label Image

Bor00 0005 08

FDA Label Image

Bor00 0005 09

Bor00 0005 09
Packaging label for Bortezomib injection, powder, lyophilized, for solution, 3.5 mg per vial by Fresenius Kabi USA, LLC. The label indicates use for subcutaneous or intravenous injection. It includes reconstitution instructions for subcutaneous and intravenous use with 0.9% sodium chloride and notes the product is sterile and cytotoxic. The label displays the NDC 63323-821-10 and provides storage guidance.*
FDA Label Image

Bor00 0005 10

Bor00 0005 10
Label for Bortezomib injection 3.5 mg per vial, a sterile, lyophilized powder for solution, intended for subcutaneous or intravenous use. The vial contains 3.5 mg Bortezomib and 35 mg mannitol. The label notes storage instructions (20° to 25°C), cautions about cytotoxicity, and specifies the vial is single-dose with unused portions discarded. Manufactured by Fresenius Kabi USA, LLC.*

* 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.