Fulvestrant Injection, Solution
Product Images NDC 70700-284

17 FDA label images from Xiromed, Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Fulvestrant (NDC 70700-284). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Xiromed, 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.

Product Images & Figures Index

FDA Label Image

Figure-1.jpg (Figure 1)

Figure-1.jpg (Figure 1)
An instructional diagram showing the process of twisting and removing parts of a medical device, likely a syringe or injection component. The parts labeled A, B, and C are shown as separate components being detached or assembled. The illustration emphasizes proper handling technique with a twisting motion indicated.*
FDA Label Image

Figure-2.jpg (Figure 2)

Figure-2.jpg (Figure 2)
An instructional diagram depicting the removal of a cap from a syringe by pulling it upward. The diagram includes labels A, B, and C on different parts of the syringe to indicate components or steps.*
FDA Label Image

Figure-3.jpg (Figure 3)

Figure-3.jpg (Figure 3)
An instructional illustration showing two hands preparing a syringe, depicting the process of drawing medication from a vial into the syringe, likely related to the intramuscular injection of fulvestrant 50 mg/mL solution.*
FDA Label Image

Figure-4.jpg (Figure 4)

Figure-4.jpg (Figure 4)
An instructional illustration showing how to properly prepare the syringe for injection by removing a protective cap or covering from the needle. The diagram includes a close-up view of the needle tip with the cap being lifted off and the fully prepared syringe ready for use.*
FDA Label Image

Figure-5.jpg (Figure 5)

Figure-5.jpg (Figure 5)
An instructional illustration showing a hand holding a syringe with an arrow indicating upward movement, likely demonstrating how to draw or handle the injection solution. This image is associated with the FULVESTRANT 50 mg/mL injection, solution for intramuscular use by Xiromed, LLC.*
FDA Label Image

Structure.jpg (Structure)

Structure.jpg (Structure)
Chemical structure of fulvestrant, the active ingredient in FULVESTRANT injection, solution.*
FDA Label Image

Figure-6.jpg (Figure 6)

Figure-6.jpg (Figure 6)
A survival curve chart titled 'Progression Free Survival (ITT Population)' comparing the proportion of patients progression free over time in months for Fulvestrant 250 mg and Fulvestrant 500 mg doses. The chart shows two declining lines representing each dose, with an accompanying table of the number of patients at risk at various time points up to 45 months.*
FDA Label Image

Figure-7.jpg (Figure 7)

Figure-7.jpg (Figure 7)
A Kaplan-Meier survival curve chart depicting the proportion of patients over time (months) for fulvestrant injections at doses of 500 mg and 250 mg. The x-axis represents time in months, while the y-axis shows the proportion of patients remaining. The chart includes tick marks indicating censored observations and a table of patients at risk below the x-axis.*
FDA Label Image

Figure-8.jpg (Figure 8)

Figure-8.jpg (Figure 8)
A Kaplan-Meier survival curve chart showing the probability of progression-free survival (PFS) over time in months from randomization. It compares two treatment groups: Fulvestrant 500 mg and Anastrozole 1 mg, with corresponding patient numbers at risk listed below the graph. The y-axis represents the probability of PFS, ranging from 0 to 1, and the x-axis shows time in months up to 39.*
FDA Label Image

Figure-9.jpg (Figure 9)

Figure-9.jpg (Figure 9)
A Kaplan-Meier survival probability curve showing progression-free survival over 14 months. The graph compares treatment groups: fulvestrant plus palbociclib and fulvestrant plus placebo, with survival probability on the y-axis and time in months on the x-axis. The plot includes the number of patients at risk for each group at various time points.*
FDA Label Image

Figure-10.jpg (Figure 10)

Figure-10.jpg (Figure 10)
A Kaplan-Meier survival curve chart comparing overall survival probability over time (months) between two groups treated with fulvestrant plus palbociclib versus fulvestrant plus placebo. The chart includes a table showing the number of patients at risk at various time points up to 54 months.*
FDA Label Image

Figure-11.jpg (Figure 11)

Figure-11.jpg (Figure 11)
A Kaplan-Meier survival curve showing progression-free survival probability (%) over time in months for two groups: patients treated with fulvestrant plus abemaciclib (solid line) and fulvestrant plus placebo (dashed line). The graph also includes patient counts at risk at various time points up to 27 months and indicates censored observations for both groups.*
FDA Label Image

Figure-12.jpg (Figure 12)

Figure-12.jpg (Figure 12)
A survival curve chart showing event-free probability (%) over time (months) comparing FULVESTRANT + Ribociclib (N=484) and FULVESTRANT + Placebo (N=242). The graph includes censoring times and a table below indicating the number of patients still at risk at various time points up to 26 months.*
FDA Label Image

Figure-14.jpg (Figure 14)

Figure-14.jpg (Figure 14)
A Kaplan-Meier survival curve chart showing event-free probability over time (months) comparing two groups: Fulvestrant+Ribociclib (N=484) and Fulvestrant+Placebo (N=242). The x-axis represents time in months, and the y-axis shows event-free probability percentage. The chart also includes numbers of patients at risk for each group at specified time points.*
FDA Label Image
Xiromed-logo.jpg (Xiromed Logo)
The image shows the carton of FULVESTRANT injection, solution with a strength of 50 mg/mL. The product is labeled for intramuscular use and manufactured by Xiromed, LLC. The packaging is primarily white with blue and gray design elements, and the brand name 'XIROMED' appears prominently.*
FDA Label Image

Carton-label.jpg (Carton Label)

Carton-label.jpg (Carton Label)
Fulvestrant Injection 250 mg/5 mL (50 mg/mL) carton label for intramuscular injection, containing 2 single-dose prefilled syringes. Manufactured for Xiromed, LLC. The label includes dosing instructions, storage conditions (refrigerate 2° to 8°C), and syringe administration illustrations. The product is Rx only with NDC 70700-284-98.*
FDA Label Image

Container-label.jpg (Container Label)

Container-label.jpg (Container Label)
Label for Fulvestrant Injection 250 mg/5 mL (50 mg/mL), an intramuscular solution by Xiromed, LLC. The label includes dosage strength, administration instructions, and storage advice to protect from light. It features two identical panels with NDC 70700-284-98, barcodes, and spaces for lot, expiration date, and administration details. The label indicates the product is manufactured in Spain for Xiromed, NJ.*

* 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.