Fulvestrant
Product Images NDC 68001-522

Product Visual Gallery

This gallery contains 19 technical images submitted to the FDA as part of the official labeling for Fulvestrant (NDC 68001-522). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Bluepoint Laboratories, 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

Fulvestrant Injection Bpl Carton (pharmez Site) Rev 06 22

Fulvestrant Injection 250 mg/5 mL (50 mg/mL) solution for injection carton from BluePoint Laboratories. The label states it is for intramuscular use only and contains two single-dose prefilled syringes. Storage instructions specify refrigeration at 2°C to 8°C (36°F to 46°F) and protection from light in the original carton until use. The label includes a barcode, manufacturer information, and usage instructions emphasizing the 500 mg dose requirement from two syringes.*

FDA Label Image

Fulvestrant Injection Bpl Label (pharmez Site) Rev 06 22

Label for Fulvestrant Injection 250 mg/5 mL (50 mg/mL) by BluePoint Laboratories. The label includes dosage strength, injection form, NDC 68001-522-86, and handling instructions emphasizing light protection and single-dose administration. Manufacturer details indicate Intas Pharmaceuticals Limited, India.*

FDA Label Image

Carton (Fulvestrant Injection Carton)

Packaging label for Fulvestrant Injection 250 mg/5 mL (50 mg/mL) by BluePoint Laboratories. The carton contains two single-dose prefilled syringes, each with 250 mg/5 mL fulvestrant, for intramuscular use only. Label notes refrigeration requirements and includes instructions and warnings. The product is Rx only, with SafetyGlide shielding needles included.*

FDA Label Image

Chemical Structure Fulvestrant (Fulvestrant Injection Chemical Structure)

Chemical structure of fulvestrant, showing its steroidal backbone with hydroxyl groups and a sulfonyl-containing side chain including trifluoromethyl groups.*

FDA Label Image

Figure 1 (Fulvestrant Injection Figure 1)

Instructional diagram illustrating the preparation of a FULVESTRANT injection syringe. The left panel shows hands twisting to open the syringe cap. The right panel labels three parts of the injection device: A (cap), B (syringe tip), and C (vial or container).*

FDA Label Image

Figure_10 (Fulvestrant Injection Figure 10)

A survival probability graph depicting overall survival probability (%) over time in months for patients receiving FULVESTRANT with either palbociclib or placebo. The chart includes two survival curves and a table showing the number of patients at risk at various time points for each treatment group.*

FDA Label Image

Figure 11 (Fulvestrant Injection Figure 11)

A Kaplan-Meier survival curve chart showing progression-free survival probability (%) over time (months) comparing two groups: Fulvestrant plus Abemaciclib (N=446) and Fulvestrant plus Placebo (N=223). The chart includes censored observations and a table listing the number of patients at risk over time for each group.*

FDA Label Image

Figure 12 (Fulvestrant Injection Figure 12)

A survival probability curve chart comparing Fulvestrant plus Abemaciclib versus Fulvestrant plus Placebo over time in months. The vertical axis shows survival probability percentage, while the horizontal axis represents time up to 57 months. Patient risk numbers are indicated below the time axis for both groups. Censored observations are marked on the curves.*

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Figure 13 (Fulvestrant Injection Figure 13)

A Kaplan-Meier survival curve showing event-free probability over 26 months for two groups: Fulvestrant + Ribociclib (N=484) and Fulvestrant + Placebo (N=242). The y-axis represents event-free probability percentage, and the x-axis shows time in months. The graph includes censoring times and patient counts at risk for both groups.*

FDA Label Image

Figure 14 (Fulvestrant Injection Figure 14)

A Kaplan-Meier survival curve chart displaying event-free probability over time in months for two groups: FULVESTRANT+Ribociclib and FULVESTRANT+Placebo. The chart includes censoring times and the number of patients at risk at various time points for each group.*

FDA Label Image

Figure 2 (Fulvestrant Injection Figure 2)

An instructional diagram showing how to remove the cap from a syringe or similar container. One panel illustrates hands pulling the cap straight up from the syringe, while the second panel labels parts of the cap mechanism as A, B, and C, depicting the sequence of removing the cap from the container.*

FDA Label Image

Figure 3 (Fulvestrant Injection Figure 3)

An instructional illustration showing two hands preparing a prefilled syringe. The top hand holds the syringe barrel steady, while the bottom hand pulls back the plunger. The image demonstrates syringe handling, likely related to the FULVESTRANT medication by BluePoint Laboratories.*

FDA Label Image

Figure 4 (Fulvestrant Injection Figure 4)

An instructional illustration showing a side view of a syringe with a needle. The image includes an enlarged circular close-up of the needle tip, highlighting its angled and beveled edge, demonstrating the needle’s design for injection.*

FDA Label Image

Figure 5 (Fulvestrant Injection Figure 5)

An instructional illustration showing a hand holding a syringe with an arrow indicating the removal of the needle cap. This image is associated with the administration process of Fulvestrant by BluePoint Laboratories.*

FDA Label Image

Fig 6 Kaplan-maier Pfs: Study 1 Itt Population (Fulvestrant Injection Figure 6)

A line chart titled 'Progression Free Survival (ITT Population)' showing the proportion of patients progression free over time in months for two dosage groups of Fulvestrant: 250 mg and 500 mg. The chart includes a table below indicating the number of patients at risk at various time points for each dosage group.*

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Figure 7 Kaplan-meier Os (minimum Follow-up Duration Of 50 Months): Confirm Itt Population (Fulvestrant Injection Figure 7)

A survival curve graph comparing the proportion of patients alive over time (in months) for Fulvestrant 500 mg and 250 mg doses. The Y-axis shows the proportion of patients alive, and the X-axis represents time in months up to 80 months. The graph includes at-risk patient counts and notes censored observations and statistical significance.*

FDA Label Image

Figure_8.jpg (Fulvestrant Injection Figure 8)

A Kaplan-Meier survival curve showing the probability of progression-free survival (PFS) over time in months from randomization. Two treatment groups are compared: Fulvestrant 500 mg and Anastrozole 1 mg, with respective patient counts at risk displayed below the x-axis for each time point.*

FDA Label Image

Figure_9 (Fulvestrant Injection Figure 9)

A Kaplan-Meier survival curve illustrating progression-free survival probability (%) over time in months for patients treated with fulvestrant combined with palbociclib versus fulvestrant with placebo. The graph includes patient numbers at risk for each treatment group at various time points, comparing the two regimens over a 14-month period.*

FDA Label Image

Label (Fulvestrant Injection Label)

Label for Fulvestrant Injection 250 mg/5 mL (50 mg/mL) by BluePoint Laboratories. The label includes product name, strength, dosage form, NDC 68001-522-86, barcodes, administration instructions, and portions with transparent and perforation areas. The label design is in purple, blue, and black text on a white background.*

* 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.