Crysvita Injection
Product Images NDC 42747-304

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Crysvita (NDC 42747-304). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Kyowa Kirin, 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 (Crysvita 01)

A line graph showing serum phosphorus levels (mg/dL) over time (weeks) comparing treatment with CRYSVITA (Burosumab) versus oral phosphorus/vitamin D. The graph plots serum phosphorus from baseline to 64 weeks, displaying higher levels maintained with CRYSVITA treatment (blue circles and solid line) compared to oral phosphorus/vitamin D (black squares and dashed line). Error bars indicate variability at each time point.*

FDA Label Image

Figure 2 (Crysvita 02)

A line graph depicting serum phosphorus levels over time in weeks, divided into 'Double-Blinded Period' and 'Open-Label Period.' It compares two regimens: placebo switching to CRYSVITA and CRYSVITA continuously. Data points are shown with error bars for each regimen, illustrating trends in serum phosphorus concentrations during the clinical study period.*

FDA Label Image

Figure 3 (Crysvita 03)

A line graph depicting serum phosphorus levels (mean ± SD in mg/dL) over a period of 144 weeks. The graph includes two data series labeled as trough (blue circles) and peak (blue asterisks). The x-axis represents time in weeks, and the y-axis measures serum phosphorus concentration. A table below the graph indicates the number of subjects at each time point.*

FDA Label Image

Principal Display Panel (10 mg/mL Vial Carton)

CRYSVITA 10 mg/mL injection carton label for subcutaneous use. The label indicates a single-dose vial, with instructions to discard unused portion. Manufactured by Kyowa Kirin, Inc. in Princeton, NJ. Includes storage instructions and active ingredients list on side panel. NDC 42747-102-01 is shown.*

FDA Label Image

Principal Display Panel (30 mg/mL Vial Carton)

Carton label for CRYSVITA 30 mg/mL injection, a subcutaneous injectable solution containing burosumab. The label shows single-dose vial packaging with storage instructions to refrigerate at 2° to 8°C and protect from light. Labeler is Kyowa Kirin, Inc., Princeton, NJ. The label includes dosage form, strength, disposal instructions, and regulatory information.*

FDA Label Image

Principal Display Panel (20 mg/mL Vial Carton)

CRYSVITA 20 mg/mL injection packaging label for subcutaneous use. The single-dose vial is to discard unused portions. The label includes manufacturer information: Kyowa Kirin, Inc., Princeton, NJ. Storage instructions specify refrigeration at 2°C to 8°C and protection from light. The label shows the NDC 42747-203-01 and states no preservatives are included.*

FDA Label Image

Principal Display Panel (10 mg/mL Vial)

Label for CRYSVITA (burosumab-twza) 10 mg/mL injection in a 1 mL single-dose vial. The label includes the NDC 42747-102-01, with subcutaneous injection route implied by the product data. It is manufactured by Kyowa Kirin, Inc., displaying U.S. License No. 2077. The label also has space for lot number and expiration date.*

FDA Label Image

Principal Display Panel (20 mg/mL Vial)

Label for CRYSVITA 20 mg/mL injection, a 1 mL single-dose vial containing the active ingredient burosumab. The product is labeled for subcutaneous injection and is manufactured by Kyowa Kirin, Inc. The label includes the NDC code 42747-203-01 and displays lot and expiration date placeholders.*

FDA Label Image

Principal Display Panel (30 mg/mL Vial)

Label for CRYSVITA (burosumab) injection, 30 mg/mL strength in a 1 mL single-dose vial. The label displays the product name, active ingredient, dosage concentration, Kyowa Kirin, Inc. as the labeler, and space for lot number and expiration date.*

* 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.