Rocuronium Bromide Injection
Product Images NDC 68083-365

8 FDA label images from Gland Pharma Limited · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Rocuronium Bromide (NDC 68083-365). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Gland Pharma Limited, 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

Rocuronium Carton1

Rocuronium Carton1
Packaging label for Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), intended for intravenous use. The label clearly shows the product name, strength, dosage form, and highlights the paralyzing agent warning. It also states 'For Intravenous Use Only' and is labeled by Gland Pharma Limited. The label includes barcode space and storage details.*
FDA Label Image

Rocuronium Carton2

Rocuronium Carton2
Rocuronium Bromide Injection 100 mg/10 mL (10 mg/mL) vial carton label for intravenous use only. The label includes a warning for a paralyzing agent and notes the product is sterile and non-pyrogenic. It is manufactured by Gland Pharma Limited. The packaging contains 10 multiple dose vials of 10 mL each. The label features a barcode and storage instructions.*
FDA Label Image

Rocuronium Structure1

Rocuronium Structure1
Chemical structure of Rocuronium Bromide, depicting the steroidal core with various functional groups including an ether, hydroxyl group, and a quaternary ammonium with a bromide counter ion, corresponding to the active ingredient Rocuronium Bromide.*
FDA Label Image

Rocuronium Structure2

Rocuronium Structure2
A scatter plot with box plots displaying time in minutes on the Y-axis and dosage in mg/kg on the X-axis. The data is grouped by age ranges: 18-64 years, ≥65 years, and 1-12 years, showing variability in the time measurements across different dosages and age groups.*
FDA Label Image

Rocuronium Structure3

Rocuronium Structure3
A box plot chart displaying data on duration in minutes for different age groups and dosage levels of Rocuronium Bromide injection. The x-axis categorizes age and dosage groups, and the y-axis shows time in minutes. Data points are shown with median, ranges, and outliers.*
FDA Label Image

Rocuronium Structure4

Rocuronium Structure4
A line chart depicting time in minutes on the vertical axis and dose number (1 to 5) on the horizontal axis. Two curves are shown representing dosages of 0.1 mg/kg and 0.15 mg/kg with sample sizes of 29 and 13, respectively, illustrating changes in minutes over the course of five doses.*
FDA Label Image

Rocuronium Vial Label1

Rocuronium Vial Label1
Label for Rocuronium Bromide Injection 50 mg/5 mL (10 mg/mL) from Gland Pharma Limited. The label states the product is sterile, nonpyrogenic, and a paralyzing agent for intravenous use in a 5 mL multiple dose vial. It includes a warning about respiratory arrest and storage instructions to refrigerate between 2 to 8°C without freezing. The label also notes that the packaging is latex-free and includes a barcode and space for lot and expiration dates.*
FDA Label Image

Rocuronium Vial Label2

Rocuronium Vial Label2
Label for Rocuronium Bromide Injection 100 mg/10 mL (10 mg/mL) by Gland Pharma Limited. The product is a sterile, nonpyrogenic intravenous injection for human use, supplied in a 10 mL multiple dose vial. The label includes warnings about its paralyzing agent properties, storage instructions, and manufacturer information with barcode and lot/expiration date fields.*

* 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.